Technical Director Salary in Cambridge, MA

West Creek 2 (12072), United States of America, Richmond, VirginiaDirector, Machine Learning Cyber EngineerCyber security is one of the biggest threats of our day. In this role, you will have the opportunity to do work that protects our company and our customers. We're looking for someone who is passionate about cyber security and will help us achieve our business needs by driving delivery of Cyber tools and by integrating with software and processes across the company. Ensuring that Capital One's Cyber Detection and Mitigation system capabilities are able to continually grow to address the newest/latest threats.As a Capital One Machine Learning Cyber Engineer, you'll be providing technical leadership to Agile teams dedicated to productionizing machine learning applications and systems at scale. You'll participate in the detailed technical design, development, and implementation of machine learning applications using existing and emerging technology platforms. Working within an Agile environment, you'll serve as a technical domain expert in machine learning, guiding machine learning architectural design decisions, developing and reviewing model and application code, and ensuring high availability and performance of our machine learning applications. You'll have the opportunity to continuously learn and apply the latest innovations and best practices in machine learning engineering. You'll also mentor other engineers and further develop your technical knowledge and skills to keep Capital One at the cutting edge of technology. What you'll do in the role: Deliver ML models and software components that solve challenging business problems in the financial services industry, working in collaboration with the Product, Architecture, Engineering, and Data Science teams.Drive the creation and evolution of ML models and software that enable state-of-the-art intelligent systems.Own the business or technical vision, collaborate with large cross-functional teams, secure commitments on deliverables and unblock teams to land business impactLead large-scale ML initiatives with the customer in mind.Leverage cloud-based architectures and technologies to deliver optimized ML models at scale.Optimize data pipelines to feed ML models.Use programming languages like Python, Scala, or Java.Evangelize best practices in all aspects of the engineering and modeling lifecycles.Attract and develop high-performing software engineers with an inspiring leadership style.Leverage your strong interpersonal, presentation/storytelling, and communications skills.Demonstrate Machine Learning industry impact through conference presentations, papers, blog posts, open source contributions, or patents.Basic Qualifications Bachelor's degreeAt least 7 years of experience designing and building data solutions using distributed computing.At least 6 years of experience programming with Python, Scala, or Java.At least 5 years of people management experience.At least 3 years of experience with the machine learning development lifecycle.Preferred Qualifications5+ years of experience delivering technical solutionsMaster's or doctoral degree in computer science, electrical engineering or mathematics.8+ years of experience within a data focused multi-line business environment.5+ years of experience designing, building, implementing, and scaling production-ready data pipelines for ML models.Capital One will consider sponsoring a new qualified applicant for employment authorization for this position.The minimum and maximum full-time annual salaries for this role are listed below, by location. Please note that this salary information is solely for candidates hired to perform work within one of these locations, and refers to the amount Capital One is willing to pay at the time of this posting. Salaries for part-time roles will be prorated based upon the agreed upon number of hours to be regularly worked.New York City (Hybrid On-Site): $274,800 - $313,600 for Director, Machine Learning EngineeringCandidates hired to work in other locations will be subject to the pay range associated with that location, and the actual annualized salary amount offered to any candidate at the time of hire will be reflected solely in the candidate's offer letter.This role is also eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). Incentives could be discretionary or non discretionary depending on the plan.Capital One offers a comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being. Learn more at the Capital One Careers website. Eligibility varies based on full or part-time status, exempt or non-exempt status, and management level.This role is expected to accept applications for a minimum of 5 business days.No agencies please. Capital One is an equal opportunity employer committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, citizenship, immigration status, protected veteran status, or any other basis prohibited under applicable federal, state or local law. Capital One promotes a drug-free workplace. Capital One will consider for employment qualified applicants with a criminal history in a manner consistent with the requirements of applicable laws regarding criminal background inquiries, including, to the extent applicable, Article 23-A of the New York Correction Law; San Francisco, California Police Code Article 49, Sections 4901-4920; New York City's Fair Chance Act; Philadelphia's Fair Criminal Records Screening Act; and other applicable federal, state, and local laws and regulations regarding criminal background inquiries.If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation, please contact Capital One Recruiting at 1-800-304-9102 or via email at [email protected]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.For technical support or questions about Capital One's recruiting process, please send an email to [email protected] One does not provide, endorse nor guarantee and is not liable for third-party products, services, educational tools or other information available through this site.Capital One Financial is made up of several different entities. Please note that any position posted in Canada is for Capital One Canada, any position posted in the United Kingdom is for Capital One Europe and any position posted in the Philippines is for Capital One Philippines Service Corp. (COPSSC).

Harvard UniversityDescription: 03-Apr-2024Assistant Technical DirectorAmerican Repertory Theater 65502BRJob SummaryThe American Repertory Theater (A.R.T.) at Harvard University is a leading force in the American theater, producing groundbreaking work in Cambridge and beyond. A.R.T. produces a mainstage subscription season, as well as additional artistic projects, which expand the boundaries of theater by transforming the ways in which work is developed, programmed, produced, and contextualized, always including the audience as a partner. A.R.T. produces a broad range of theatrical entertainment including new works, pre-Broadway premieres, co-productions and transfers, and international tours.Through groundbreaking and transformational theatrical experiences, A.R.T. believes that theater has the power to heal and imagine collective pathways forward. A.R.T. affirms and celebrates a multitude of perspectives and experiences that reflect the diversity of our country and world, and is dedicated to making a welcoming and accessible space for people of any identity, background, or ability.As the professional theater on the campus of Harvard University, A.R.T. is committed to the collaborative and creative exchange among a wide range of academic departments, institutions, students, and faculty members. A.R.T. plays a central role in Harvard’s undergraduate Theater, Dance & Media concentration and also mentors students in the Harvard Radcliffe Dramatic Club at the Loeb Drama Center.The Assistant Technical Director (ATD)— is responsible for the technical design and drafting of scenery as well as coordination with the shop supervisor, purchaser, scenic charge and other relevant stakeholders regarding necessary scheduling, staffing, material acquisition, product research, prototyping, and similar to complete construction on time, safely, and to standards of quality expected by ART. Attention to trucking, touring, structural integrity, reliability, efficiency in manufacturing, load-in, and strike, as well as a high standard of finish are critical to success. Additionally, the ATD will actively participate in load-in activities, attend tech rehearsals as needed, supervise load-in and strike operations, and oversee the archiving of shows. Clear communication with colleagues, along with promoting training and safe practices among theater staff, are essential aspects of the role. The ATD will also be responsible for designing and executing mechanical and motion control systems as required, collaborating with contracted experts on areas such as code compliance, engineering, and automation. Participation with maintenance and other project work will also be required.Position DescriptionPosition Responsibilities Promote an inclusive and safe work environment:Foster a culture of community, anti-racism equity, diversity, inclusion, and respect among staff and guest artists.Foster a culture of safety, both psychologically and physically, and ensure safe work environment and practices are observed.Participate in companywide anti-racism and anti-oppression initiatives.Attending all company, department, shop meetings, and as necessary, safety training. Support Artistic Vision and Goals:Uplifts the mission, vision, and values of A.R.T with staff and overhireWorks with the entire scenery department to implement scenic designs.Technical Design, Research, & PrototypingRemain within budgetary and timeline parameters, develop technical solutions that are mindful of rep, transfer, scene shifts, truck loading, code, structural concerns, rigging parameters, visual (design) requirements, and performer requirements,Coordinate with other production department needs when scenic element directly affects them. Lead product research when necessary—often working with Purchaser.Collaborate with shop supervisor and staff fabricators to develop prototypes of solutions to scenic problems or new techniques. This is generally done in close coordination with the Technical Director (TD) to identify and resolve specific areas of concern.Some interfacing with designer to clarify specific needs and details as well as communicate progress and concerns.DraftingIn accordance with drafting standards, generate detailed construction drawings in AutoCAD for all fabricated scenery.Provide clarity on design drawings for scene shop team and coordinate with designers if intentions in drawings are unclear, as needed.Ensure accurate conversions of design drawings from other platformsAutomation & FX DevelopmentCollaborate with the TD to devise appropriate automation solutions, including hydraulic, winches, pneumatics, hoists, etc., as needed.Collaborate with the TD to devise suitable special effects (FX) solutions such as rain, fog, magic, water/pools, flame/pyro, flying, rigging, etc., when required.Coordinate cross departmental needs with other departmental heads (rigging requirements, power and distribution needs, etc.).Work directly with both ART staff and outside vendors when suitable to effectively execute automation and/or FX solutions.Load in, Tech, & StrikeCoordinate load-in plans with heads of other A.R.T. production departments.Prepare detailed documentation for shows, including but not limited to piece lists, truck packs, assembly drawings/instructions, and operational requirements.Attend select technical rehearsals and/or previews to representing scene shop interests.General CommunicationAttend and contribute to brief daily morning meetings with full scene shop staff.Remain up to date with rehearsal and performance reports as well as communications internal to the scene shop.Collaborate in coordinating fabrication with paint and other relevant departments.Comprehensive hand-off of drafting to fabricators.Regular follow-up communication with project advancement on the floor.Contribute to shared shop systems of records, drafting templates, archiving, general record keeping and conventions, etc.Engage with stage management, stage operations department members, and other heads of departments to address load-in/strike requirements, scenic operation and maintenance requirements, safe automation operations and protocols, and similar.Foster an environment of safety, professionalism, diligence, appropriate conduct, collaboration, and growth.Basic QualificationsTwo years of college or equivalent and four years in a scenic fabrication environment—educational or professional.Command of engineering fundamentals and experience with their applied application to non-theoretical problems.Proficient with AutoCAD and MS Outlook and Excel.Demonstrated expertise in adhering to safe and industry-standard rigging practices, with hands-on experience in building rigging systems.Ability to thrive in a fast-paced environment with multiple concurrent priorities, maintaining effectiveness and composure.Strong working knowledge of Microsoft Office Programs, including Outlook, Word, and Excel. Sharepoint experience preferred.Excellent communication abilities, both in expressing ideas and actively listening to others.Punctuality and a proven track record of meeting deadlines consistently.Self-motivated, detail-oriented individual with a proactive approach to planning and problem-solving.Dedication to craftsmanship, coupled with a strong work ethic, commitment to safety, teamwork mentality, and a continuous drive for learning and improvement.Maintain and promote a safe work environment by following and enforcing all safety regulations, providing safety equipment, training employees on safe practices, reporting incidents, managing record keeping, staying up to date on safety issues, and advising on safety-related policy and decisions.With advanced notice, ability to work a flexible schedule including morning, evening, and weekend hours.Additional Qualifications and SkillsIf you believe this is a role that you will be excited to work in, even if you do not have the following we encourage you to apply:Hands-on experience with the execution/application of a range of automated systems such as motors and their control, pneumatics, hydraulics, etc. as well as the design of such systems.Have a class D driver’s license and the ability to drive 26’ trucks in urban settings.Experience with TIG welding, CNC routing, sewing, Creative Conners, PRG Automation, Hudson Automation, Cybermotion, machining, wiring, budgeting, sculpting, painting, plastics fabrication techniques, aluminum, etc.ETCP certification.Experience building in off-site facilities, touring, repping, and working with transfers to commercial and other venues is helpful as is prior professional experience fabricating for the entertainment industry.Physical RequirementsComfortable working at heights—climbing scaffold, stairs to grid, or similar. Ability to sit in workstation, type and work with a computer for extended periods of time.Ability to lift 50 pounds and work in confined quarters when working on automation and FX systems.Additional InformationMonday through Friday. Full Time. 7:30a – 4:00p; some Saturday, & Sunday calls to meet deadlines; and additional required hours including evenings during periods of tech, strike, load-in, etc.The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up to date on CDC-recommended vaccines. Work Format DetailsThis position is based primarily on-campus, in Massachusetts. This may include in-person during emergency situations (if applicable). Additional details will be discussed during the interview process. Certain visa types may limit work location. Individuals must meet work location sponsorship requirements prior to employment.BenefitsWe invite you to visit Harvard's Total Rewards website (https://hr.harvard.edu/totalrewards) to learn more about our outstanding benefits package, which may include: Paid Time Off: 3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers. Health and Welfare: Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date. Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more. Retirement: University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service. Tuition Assistance Program: Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools.Tuition Reimbursement: Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions. Professional Development: Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning.Commuting and Transportation: Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more. Harvard Facilities Access, Discounts and Perks: Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston.Job FunctionArts Department Office LocationUSA - MA - Cambridge Job CodeAR0255 Stage Associate I Work FormatOn-Site Sub-Unit------------ Salary Grade055DepartmentProductionUnion00 - Non Union, Exempt or Temporary Time StatusFull-time Pre-Employment ScreeningEducation, IdentityScheduleMonday through Friday. Full Time. 7:30a – 4:00p; some Saturday, & Sunday calls to meet deadlines; and additional required hours including evenings during periods of tech, strike, load-in, etc.Commitment to Equity, Diversity, Inclusion, and BelongingHarvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs, and values.EEO StatementWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.LinkedIn Recruiter Tag (for internal use only)#LI-KP1 PI239108251

The Role:Reporting directly to the Senior Director or Executive Director of Medical Writing, this pivotal role carries the significant responsibility of ensuring the delivery of high-quality clinical and regulatory writing. From meticulous planning and coordination to delivering the final drafts, the role demands a keen eye for detail and a robust understanding of the clinical development landscape. This individual will form an integral part of Moderna's clinical development team, working closely with them to understand and contribute to the broader objectives of Moderna's clinical development program. This is not just a job, it's an opportunity to drive change and make a difference in the world of biotechnology.Here's What You'll Do:Functional Knowledge: Demonstrate a comprehensive understanding of concepts and principles for overseeing the managing medical writing and regulatory writing across multiple clinical development programs.Document Planning & Project Management: Oversee the planning, writing, and reviewing of clinical and regulatory documents and responses.Cross-Functional Collaboration: Work closely with cross-functional teams to ensure timely delivery of high-quality documents.Regulatory Compliance: Ensure all documents comply with regulatory guidelines.Data Interpretation: Interpret clinical and statistical data to prepare clear, concise documents.Quality Control: Implement and oversee quality control processes for medical writing.Document Updates: Manage the updates and revisions of documents as required.Problem Solving: Direct the resolution of highly complex or unusual business problems applying advanced critical thinking.Impact: Guided by functional plans, impact the quality and timeliness of the functional area and results, and develop area plans.Develop and Implement Departmental Strategies: Set goals and objectives for the medical writing team that align with the company's overall strategy.Line Management: Oversee and manage the performance of a high-performing medical writing team, providing guidance, feedback, and mentorship. Responsible for hiring, training, and professional development of team members. Ensure resources are allocated effectively and deadlines are met consistently. Foster a collaborative and positive team environment.Here's What You'll Bring to the Table:Education and Years of Experience: Advanced degree (preferred) with approximately 10 years of relevant experience OR bachelor's degree with approximately 15 years of relevant experience.Interpersonal Skills: Ability to influence others internally and/or externally, including colleagues in other departments. Some negotiation with limited impact may be required.Leadership Skills: Ability to lead dynamically through senior managers or professionals. Translate and execute functional business strategy across multiple related disciplines and contribute to strategic planning for medical writing.Business Expertise: Apply market knowledge to drive integrated results across multiple related teams.Communication Skills: Excellent written and oral communication skills.Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.Technical Skills: Proficiency in MS Office and familiarity with medical writing software.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-MM1-

The Role:Moderna Infectious Disease is seeking an exceptionally talented, highly creative, and motivated senior scientific leader with a broad skill base in computational protein design, structural informatics, in vitro evolution, and vaccine design, to lead computational antigen design within Moderna's Antigen Design and Selection team. The Director, Computational Antigen Design and In Vitro Evolution, will be part of a highly collaborative, multi-disciplinary, and fast-paced team that is translating Moderna's mRNA technology into an exceptionally broad portfolio of vaccines and therapeutics against infectious diseases. The Director will employ their extensive expertise in computational design, including both deep learning-based design and design specifically for nucleic acid delivery, bioinformatics, in vitro evolution, protein biochemistry and biophysics and vaccinology to lead a growing team of scientists focused on the development of novel antigens or therapeutics proteins that can be successfully encoded via Moderna's mRNA technology. The Director will work closely with the VP, Antigen Design & Selection, the Senior Director, Structure-Guided Antigen Design, and the VP, Immunology, as well as other members of the Research, Clinical Development and Clinical Biomarker teams to advance novel candidates to the clinic, conduct exploratory trials to inform the generation of improved vaccine antigens and dissect immune responses elicited by vaccination.This is a unique opportunity to work in an innovative environment on a truly transformative infectious diseases platform.Here's What You'll Do:Reporting to the Vice President for Antigen Design & Selection, the Director will:Lead the computational design, bioinformatics, and in vitro evolution teams within Antigen Design & Selection, to drive the iterative optimization of vaccines and therapeutics for Moderna Infectious Disease ResearchGuide team members in cutting edge computational design, informatics, and methods development including but not limited to deep learning-based methodsGuide team members to develop creative, structurally and immunologically targeted design solutions for a wide range of vaccine and therapeutic challengesCollaborate with other members of the Moderna infectious disease research leadership team to formulate strategy for development of vaccines and therapeuticsContribute structure-guided design and iterative optimization workflows to collaborations with other Moderna therapeutic areas for development of additional vaccines and therapeuticsExplore, test and implement innovative tools and practices that will optimize the potential of the mRNA platform for Infectious Disease Research.Contribute to the broader scientific and platform community at Moderna TherapeuticsContribute to the communication of R&D data for Infectious Disease Research through internal and external presentations and publications.Identify and nurture relationships with CROs and leading academic centers with state-of-the art capabilities for protein design, characterization andAs a member of the Research Leadership team, help shape the overall portfolio of approaches and problem-solve their technical executionHere's What You'll Bring to the Table:PhD in Biochemistry, Molecular Biology, Biophysics, Computer Science, Immunology, Structural biology, or related field relevant to the role with 10 years of experience in computational protein design and informatics in Academia or industryExtensive experience in computational protein design, structural informatics, in vitro evolution, design of vaccines and antibodies for nucleic acid delivery, computational algorithm development, protein biochemistry and biophysics, and animal studies and vaccine evaluationProven record of discovery of several vaccines with successful proof-of-concept studies in animal models and, ideally, in human studiesExperience in carrying projects through to IND or other equivalent early clinical milestoneAbility to effectively lead and collaborate in a dynamic, cross-functional matrixed environment.Experience working with and overseeing partnerships with academic, industrial, governmental and other non-governmental organizationsOutstanding communication skills (verbal and written) Ability to manage multiple projects in a fast-paced environmentStrong leadership experience, including strategy and team managementCandidate will be curious in exploring new path for drug discovery, bold in proposing creative experimental designs and ideas.Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomesModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-KF1-

The Role:Moderna is seeking a Director of Epidemiology, Early HEOR & Patient-Centered Outcomes Assessment (Epi, & PCOA) to support the strategy, design and implementation of evidence generation activities activities targeted towards supporting the regulatory approval and reimbursement of Moderna's Rare Disease mRNA technologies within its Therapeutics portfolio at the global level. The candidate has responsibility, under the supervision of the Epi Director, who is the Program Lead for various Rare Disease to lead one of these indications. This includes the design, development, conduct, analysis, reporting and publication of pharmacoepidemiologic research studies, PCOA measurement and development strategy (where warranted), plan and execute the early reimbursement/HEOR activities and provide epidemiologic and methodologic input towards the clinical development needs of mRNA technologies.Specifically, the candidate will support and/or lead as appropriate, activities focusing on generating observational evidence to support mRNA technologies (early and late stage) associated with Inborn Errors of Metabolism. The role will report to the Director, Epidemiology Lead. The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to ground-breaking drug development with potential to transform multiple diseases with very high unmet medical need. The candidate must have excellent oral and written communication skills, innovative approaches, a willingness to learn new concepts and a collaborative mindset. As this is a global role, the candidate may be called upon to work across different time zones at times. The candidate will be charged with understanding the observational data needs and opportunities to enhance drug development with the mRNA platform, and build expertise as needed within the Rare Disease portfolio.Here's What You'll Do: Epidemiology:Under the guidance and strategic leadership of the Senior Epi/ PCOA lead, accountable for the development and execution of the overall Epi/PCOA strategy for Propionic Acidemia (PA) and other future indications as determined by the needs of the portfolio.Provide Epi input to the product development, including clinical, safety, and economic outcomes and contribute to the integrated evidence plans for PADesign and execute pre-launch, launch and post-marketing epidemiology/real world evidence plans, as neededResponsible to support the strategy, vision and execution of high-quality pharmacoepidemiologic data outputs, for PA including:Develop protocols, data analysis plans, study reports and peer-reviewed publications.Conduct Literature reviews and gap analyses for safety, effectiveness, and impact studies.Conduct studies from conceptualization, through publication of descriptive, cohort, cross-sectional, or observational studies or registriesDesign and input into clinical trial or external control studies to ensure value-drivers for provider/patient/payer evidence needs from launch through LOE are includedProvide epidemiologic analysis, literature reviews, or literature-based indirect treatment comparisons to fill knowledge gaps and inform (data contextualization, event rates, population descriptors, etc)Active leader and team member providing strategic input in terms of observational data and strategy to the development team in collaboration with cross-functional partners on the clinical development plan, regulatory interactions, clinical study design, efficacy and safety endpointsSupport mRNA development by strategic contribution to the assessment of need for use of observational data, evaluation of data sources, design and conduct of observational studies for RD needs and/or developing mRNA technologies With guidance and direction from Indication Epi Lead, serve as a cross functional partner for HTA advice & building of economic models at global levelProvide epidemiologic support to other RD Moderna therapeutics programs as neededPreferred: Analytical skills and technical knowledge of registries/real world data studies; general understanding of global (US, EU) payer and market access evidentiary needs and reimbursement environment and the processes associated with reimbursement and formulary access to enable input into CDP and other evidence generation needsReal World Evidence & Early HEOR:Identify evidence gaps and needs from regulatory and reimbursement perspectives, resolve these challenges and define evidence generation priorities to support payers and regulatorsLeading early payer scientific advice with global stakeholders including strategic insights on PROs, economic models and trial designDefining and delivering the RWE and early HEOR strategy to support specified assets, and leading the integrated evidence teams to execute the activities needed for advancing assets through to launchProvide innovative solutions on RWE for use as a synthetic/historical or concurrent control, including expertise on methodological considerations to account for confounding, missing variable, temporal or other biases and/or methodological challenges which may need to be thought through, including alternative methodological approaches (Bayesian, Adaptive, etc)Develop research methodologies and implement innovative analytical approaches for Epi & RWEDevelop protocols for RWD analysis of claims data or electronic health records and execution of RWE studies to identify and fill gaps and ensure delivery of robust evidence alongside clinical development and value-based RWE needsProactively prepare for mRNA use and exposure by establishing epidemiological and RWE on the key disease, population, demographic and clinical variablesLead RWE publications for congresses and peer-reviewed journalsDevelop and maintain strong, collaborative relationships with the broader Moderna organization and with external expertsPatient-Centered Outcomes Assessment (PCOA):Support PCOA, including the development, validation (or adaptation) and creation of Clinical Outcome Assessments (COA) and psychometric measurement strategy Select & incorporate COA endpoints and implement strategy and input into COA measurement section protocols and CDP and to develop briefing documents in support of and attend regulatory interactions as the Moderna subject matter expertHere's What You'll Bring to the Table:PhD in Epidemiology, Pharmacoepidemiology or Health Economics strongly preferred and MPH/MS in Epidemiology in combination with other advanced degrees considered. Preference given to candidates with previous experience in drug developmentMinimum 5-7 years' experience in an industry setting, preferably in a related therapeutic area and at least 8-10 years experience in consultancy supporting RWE/HEOR type activitiesProven track record in:Planning and execution of Epidemiology/RWE and HEOR Plans to enhance value and accelerate developmentDeliver high-quality results within established timelinesLead cross-functional teams and work streamsAbility to interact with local and or regional stakeholdersInnovation in trial design including leveraging synthetic controls and real-world dataAbility to thrive and multi-task in a fast-paced environment is ESSENTIALAttention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goalsExcellent analytical, problem-solving and strategic planning skillsStrong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functionsExceptional written and oral communication skills to meet the needs of varied audiencesModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

Center 1 (19052), United States of America, McLean, VirginiaDirector, Cybersecurity Product ManagementCapital One is seeking a technical security product leader to deliver game-changing cybersecurity solutions based on threat, data, and design thinking. We are a technology-oriented company delivering financial products to market through modern technology and constant innovation at a massive scale. That innovation includes leveraging technology to deliver the best cybersecurity solutions for our internal and external customers. As a candidate for this role, you're able to seamlessly switch from executive-level risk conversations to diving deep into controls and technology to driving high level, strategic discussions around roadmaps and security solutions. You are naturally curious and stay on top of emerging trends and threats. You are not afraid to question any existing processes and solutions, yet you display a keen sense of business value proposition and focus on the right priorities. You are a clear thinker, thrive in working across teams, and an expert in dealing with ambiguity. You believe that a core component of security's role is to enable the business, not just to secure it, and the solutions you bring to life are aligned to the needs of our engineering community and business partners. You thrive in working in a fast paced, technologically forward leaning environment and are not afraid to push the boundaries of security capabilities. What you'll do...Develop and communicate a risk-based and data-driven strategy and outcome-driven roadmaps for enterprise security services, solutions, and capabilities, in partnership with engineering and operations partners, customers, and other stakeholdersAnalyze and select alternatives based on threat, risk, desirability, feasibility, and viabilityKeep abreast of advances in industry to address the threat landscapeAdvise executive decision makers based on business and technology risk grounded in threatFacilitate build vs. buy decisions to identify optimal strategies for addressing business and technology risksDevelop and lead RFI/RFPs to assess the market and/or procure effective cyber solutionsMaintain technical and risk credibility with your own team and with partners across the enterpriseMaintain close ties to various stakeholders, developers, and engineers across the company, ensuring the services we create meet their needs as products evolveIterate quickly and see the products through to production and scaleEstablish product value propositions, metrics, and key indicatorsRecruit, motivate, mentor, and lead those around you to be their bestAbout You...You have built and led teams of senior level product managersYou have strong consulting and analytical skillsYou have the ability to foster collaborative, open, working relationships with technology groups and other stakeholders, including vendor relationshipsYou have demonstrated clear communication skills and ability to interact effectively at all levels of an organization, and to influence senior management and executives (Including translating technical information based on specific audiences)You have experience managing multiple high-visibility and high-impact enterprise cybersecurity programs with cross-functional teams while maintaining superior results including planning, development and management of technical requirements, design, testing and deployment of security solutionsYou have a proven track record of managing all aspects of a successful product throughout its lifecycleProven ability to develop product strategies and effectively communicate recommendations to executive managementYou have a passion for cybersecurity.Basic Qualifications:Bachelor's degreeAt least 7 years of experience in cybersecurityAt least 5 years of people management experienceAt least 5 years of experience translating cybersecurity strategy and analysis into product and service requirementsPreferred Qualifications:Advanced degree in Computer Science5+ years of experience in public cloud security3+ years of experience in Cloud Networking3+ years of experience in Product Management1+ years of experience in regulated financial service organizationsIndustry recognized professional certifications (CISSP, GIAC, CISM, CCSP, CISA, CRISC, SAFe Product Management, AWS Security, AWS Advanced Networking Specialty, AWS Solutions Architect)At this time, Capital One will not sponsor a new applicant for employment authorization for this position. The minimum and maximum full-time annual salaries for this role are listed below, by location. Please note that this salary information is solely for candidates hired to perform work within one of these locations, and refers to the amount Capital One is willing to pay at the time of this posting. Salaries for part-time roles will be prorated based upon the agreed upon number of hours to be regularly worked.San Francisco, California (Hybrid On-Site): $291,100 - $332,300 for Director, Cyber TechnicalCandidates hired to work in other locations will be subject to the pay range associated with that location, and the actual annualized salary amount offered to any candidate at the time of hire will be reflected solely in the candidate's offer letter.This role is also eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). Incentives could be discretionary or non discretionary depending on the plan.Capital One offers a comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being. Learn more at the Capital One Careers website. Eligibility varies based on full or part-time status, exempt or non-exempt status, and management level.This role is expected to accept applications for a minimum of 5 business days.No agencies please. Capital One is an equal opportunity employer committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, citizenship, immigration status, protected veteran status, or any other basis prohibited under applicable federal, state or local law. Capital One promotes a drug-free workplace. Capital One will consider for employment qualified applicants with a criminal history in a manner consistent with the requirements of applicable laws regarding criminal background inquiries, including, to the extent applicable, Article 23-A of the New York Correction Law; San Francisco, California Police Code Article 49, Sections 4901-4920; New York City's Fair Chance Act; Philadelphia's Fair Criminal Records Screening Act; and other applicable federal, state, and local laws and regulations regarding criminal background inquiries.If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation, please contact Capital One Recruiting at 1-800-304-9102 or via email at [email protected]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.For technical support or questions about Capital One's recruiting process, please send an email to [email protected] One does not provide, endorse nor guarantee and is not liable for third-party products, services, educational tools or other information available through this site.Capital One Financial is made up of several different entities. Please note that any position posted in Canada is for Capital One Canada, any position posted in the United Kingdom is for Capital One Europe and any position posted in the Philippines is for Capital One Philippines Service Corp. (COPSSC).

The Director of Quality Development will oversee the managers responsible for the quality of our IRIS and HealthShare products and DevOps. This person will collaborate extensively with other department leaders to ensure a high quality delivery of our products Solution Partners and End Users.. InterSystems take pride in the quality of our products we deliver to the client, and your departments act as the final seal of approval to ensure its meeting the companies high standards. Duties and Responsibilities: Lead a team of Managers responsible for overseeing individual contributors working in various technical roles across Quality Development Work across all Scrum Teams to ensure there is high attention to problem solving, quality, performance, and deadlines. Regularly inspect current team processes, third-party software, and departmental best practices to ensure consistent, thorough, high quality deliverables from the team. Foster and maintain a learning culture that is innovative, collaborative, and supportive and motivating. Maintain and develop an in-depth knowledge of product functional areas. Required: 8+ years experience leading software development and/or engineering teams of at least 10 people Experience developing or testing software products in varied environments Software development or software QA leadership including managing technical staff Effective communication and analytical skills Curiosity and aptitude for acquiring new technical skills and knowledge in a dynamic and highly technical environment Creative leadership Desirable: Experience with distributed systems and networking Experience with relational databases Experience with software test tools and automation methodologies Experience with software development in an Agile environment Experience with cloud, container, and provisioning technology such as Docker and Kubernetes Experience with one or more of the following programming lanugages -: Python, C, C++ Experience with UI development (Angular, Typescript, JS) and UI test automation (Selenium) Education and Training: BS/MS or higher in Computer Science, STEM or Engineering Degree About InterSystems Established in 1978, InterSystems provides innovative data solutions for organizations with critical information needs in the healthcare, finance, and logistics sectors and beyond. Our cloud-first data platforms solve interoperability, speed, and scalability problems for organizations around the globe. InterSystems also develops and supports data management in hospitals through the world's most proven electronic medical record, as well as unified care records for health systems and governments through a powerful suite of healthcare data integration solutions. The company is committed to excellence through its award-winning, 24×7 support for customers and partners in more than 80 countries. Privately held and headquartered in Cambridge, Massachusetts, InterSystems has 25 offices worldwide. For more information, please visit InterSystems.com .

To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan.To develop human resources for appropriate business operations and enhance organizational capabilities by improving the problem-solving skills and mutual assistance system as a section.Financial Outcome Draw up budget plans necessary for the implementation of operations as PV Regulatory, confirm that these plans have been appropriately implemented, and modify the plans as necessary.Operation and Improvement Prepare package insert for the approval application/coordinate to revise package insert in post-marketing phase when necessary and submit and disclose the package insert approved by the regulatory authority.Negotiates and coordinates with the regulatory authorities in pharmacovigilance activities as the primary contact and gives advice on materials to be submitted to the regulatory authorities. Collect and analyze information on local regulatory requirements, policies and guidelines related to PV activities, promptly notify any information with potential local and global impact and support reflecting it to procedures appropriately.InnovationIn preparation for global expansion, cooperate formulating G-SOPs and SOPs, and establishing a global safety management system.Establish and maintain a system to share and advise on domestic regulatory information related to pharmacovigilance activities (regulatory intelligence).Talent Development and Organization Growth To develop human resources for appropriate business operations and enhance organizational capabilities by improving the problem-solving skills and mutual assistance system as a section.External/Internal RelationshipInvolve internal and external stakeholders (Including departments, related departments, headquarters, partner companies) to proactively implement the PDCA for pharmacovigilance activities.Educational RequirementsBachelor of Science (B.S.) degree from an accredited educational institution, or the equivalent in experience required. A Master of Science (M.S.), Doctorate of Pharmacy (Pharm.D.), or Doctorate of Philosophy (Ph.D.) degree in the life or physical sciences is preferredExperienceTen (10) years of regulatory experience for small molecules and biologics within the pharmaceutical or biotechnology industry, along with demonstrated success as a PV, Regulatory Affairs organizational leader, able to lead, direct and develop member of the PV regulatory function. Knowledge and experience in US and EU regulations, PMDA, ICH guidelines, and understanding of Individual Case Safety Reports (ICSR), safety database and safety gateway are required.Significant work experience and management experience in the PV, Regulatory Affairs department of an established United States-based pharmaceutical company, having worked directly with the Food and Drug Administration (FDA) to successfully obtain drug approval is required for this position. Although the scope of responsibility for this position is primarily domestic (United States, it is preferred that the incumbent possess knowledge and experience in European and Japanese PV, Regulatory Affairs.)Technical SkillsThorough understanding of all aspects of pharmaceutical product development and regulatory requirements.Cognitive Skills Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomesLanguage/Interpersonal Skills Ability to communicate with internal and external stakeholders Physical Demands Work is generally sedentary in nature, but may require standing, walking, grasping, to maintain a neat and organized work environment.Work Environment The noise level in the work environment is usually quiet.Business Travel This role requires the incumbent to travel (domestic and/or international) based upon the needs of the business, up to 30% of the time.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)

ABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets with next-generation precision medicines. QurAlis' proprietary platforms and unique biomarkers enable the design and development of drugs that act directly on disease-causing genetic alterations. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a deep pipeline of antisense oligonucleotides and small molecule programs including addressing sub-forms of ALS that account for the majority of ALS patients. SUMMARY OF POSITION The Director of Drug Substance Manufacturing at QurAlis plays a pivotal role in developing and optimizing chemical processes for Oligonucleotides production and overseeing the refinement of external manufacturing processes. This leader is tasked with steering a team through process development, scale-up, analytical, and technology transfer to manufacturing sites, including managing operations and coordinating with Contract Manufacturing Organizations. His responsibilities are critical to ensuring the consistent delivery of high-quality drug substances for clinical and commercial use, adhering to stringent regulatory standards. By optimizing manufacturing strategies and fostering collaboration with cross-functional teams, the Director plays an instrumental role in enhancing efficiency, quality, and safety, driving innovation, and ensuring that manufacturing practices are in sync with QurAlis' core values. Primary Job Responsibilities: Oversee the operation of drug substance manufacturing at our Contract Manufacturing Partners, ensuring compliance with all regulatory, safety, and quality standards. Develop and optimize scalable chemical processes for the synthesis of drug substances, focusing on efficiency, yield, and purity. Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence. Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Manage relationships with contract manufacturing organizations and ensure they meet our quality and production requirements. Oversee technology transfer of drug substance processes to CMOs. Prepare technical reports and presentations to communicate results and progress to internal and external stakeholders. Contribute to the preparation and filing of IMPD, IND, and NDA documentation. Develop and manage the DS budget, ensuring efficient use of resources and cost-effective processes. Implement continuous improvement initiatives to enhance manufacturing efficiency, reduce costs, and improve product quality. Collaborate with regulatory affairs to support regulatory submissions and inspections. Stay informed about industry trends, technological advancements, and regulatory changes to ensure our manufacturing processes are competitive and compliant. Primary Job Requirements: Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent, with significant experience in Oligo chemistry. Proven track record in Active Pharmaceutical Ingredient process development, including scale-up and technology transfer, coupled with a deep understanding of synthetic organic chemistry. Proficient in synthesizer operation, chromatography, and principles of process optimization and scale-up. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing. Experience in working with CMOs and managing external partnerships. Excellent communication, organizational, and project management skills. Ability to think strategically and solve problems effectively. Commitment to fostering a collaborative and inclusive work environment.

The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support INT within the Oncology programs. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA oncology products as unprecedented new drug modality in the U.S. and other markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate. Prior regulatory experience with Oncology development preferred.Here's What You'll Do: Serve as global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the projectRepresent Regulatory Affairs on cross-functional project teams.Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate.Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the Regulatory Affairs Management Team, Project Development Team and senior management, as relevant.Collaborates with internal teams and Moderna partners to achieve project goals, including development content and management of submissions to Health Agencies.Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related supplements and amendments.Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.Monitors regulatory developments related to mRNA platform and advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes.Establishes and maintains excellent relationships with regulatory agency personnel.Negotiates directly and effectively with health agencies regarding company's filings. Responds to requests for additional data, organizes and manages participation in meetings.Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.Serves as regulatory science representative to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.Supports development and maintenance of the Target Label Profile and the Company Core Data Sheet.Identifies areas in need of improvement and lead the development and implementation of process improvements Conducts risks and gaps assessment and identifies potential areas of regulatory concern and responds to new government/regulatory developments.Manages resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverablesHere's What You'll Bring to the Table:BA/BS degree in a scientific/engineering discipline required. PharmD, Masters or PhD preferred.10+ years of experience in the Pharmaceutical industry8+ years of experience in Regulatory strategy, including specifically: Oncology DevelopmentExpert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Oncology programs.Strong experience with CTD format and content regulatory filingsExperience with developing and implementing competitive regulatory strategies Demonstrated track record in securing product approvals and maintaining a complex portfolio is preferredKnowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance - preferably from at least both US and EU Direct experience of leading regulatory authority meetings in different phases of drug development Regulatory knowledge across therapeutic areas including Oncology development is preferable. Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)Ability to work independently to manage multiple projects in a fast-paced environment. Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones.Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, the Project Team and senior management, as relevant.Identify areas in need of improvement and lead the development and implementation of process improvements.Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-JW2-