Escalation Manager Salary in Cambridge, MA

Job DescriptionJob Overview:The Access and Reimbursement Manager (ARM) plays a pivotal role in securing and maintaining patient access to Biogen MS therapies by engaging with Key Neurology Accounts and TOUCH Authorized Infusion Providers. This role demands expertise in reimbursement and payer access, coupled with a deep understanding of local marketplace dynamics. The ARM collaborates across all levels of healthcare providers and systems, driving innovative strategies to optimize patient access and enhance outcomes. Responsibilities include implementation of patient access strategy, site of care management, and resolving complex reimbursement issues. The ARM serves as a key liaison between internal teams and external stakeholders, ensuring alignment and execution of tactical plans.Principal Responsibilities:Neurology Account Engagement:Develop business plans for Priority Accounts in collaboration with matrix team.Conduct Biogen Portfolio Overviews to enhance revenue optimization and improve provider and patient satisfaction.Deliver provider education through ARM-led and Peer to Peer programming.Infusion Site Management:Develop regional infusion site strategy and oversee its implementation.Ensure compliance with REMS program, medical and site of care policies, including REMS certification.Provide education and support on billing/coding, coverage/payment, and clinical aspects of MS therapies.Patient Access & Provider Reimbursement:Navigate patient services escalations and resolve complex reimbursement issues.Initiate and maintain patient access to Biogen therapies across the MS portfolio.Cross-functional Leadership & Collaboration:Analyze business trends and opportunities as part of the Regional Director Leadership Team.Lead regional initiatives related to patient access and collaborate with local field teams and patient services.Provide ongoing education on services, solutions, and access across the matrix team.Who You Are:The ideal candidate is a detail oriented and analytical with exceptional interpersonal and presentation skills, adept at navigating complex, matrixed environments with ease. They excel in strategic business planning, leveraging their strong written and verbal communication abilities to drive impactful results and foster organizational success.QualificationsMinimum Experience Requirements:Minimum 5-7+ years of pharmaceutical/biotech experience.Track record in field reimbursement, clinical education, or pharmaceutical sales/management.Experience navigating complex accounts.Strong presentation and communication skills.Knowledge of Managed Care and patient privacy laws.Valid driver's license.BS/BA Required, MBA Preferred Candidates must live within the assigned territory; (MD, DE, Eastern PA, Southern NJ)Key Competencies:Customer Focused: Prioritizes patient, payer, and physician needs, fostering strategic relationships.Problem Solving: Demonstrates creative problem-solving abilities and innovative thinking.Manages Complexity through Collaboration: Integrates complex information and maintains connections with stakeholders.Healthcare and Reimbursement Business Acumen: Stays updated on healthcare policy, payers, and market trends.Engaging Others Through Effective Communication: Delivers persuasive presentations and builds effective relationships.Impact and Influence: Executes influence strategies to advance shared business goals.Additional: The ARM will be field based and require significant travel that may extend from 40-80% depending on the territory geography, customer requirements, meetings and required training.The ARM must demonstrate a long-term track record of adherence to Corporate Compliance Policies.Additional InformationThe base compensation range for this role is $150,000 to $217,500. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.Why Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9baf3a35-ab91-41f9-9a2c-de2ce0cfd6e9

The Role:As the Manager of HR Operations, reporting to the Associate Director, you will lead the supervision and enhancement of HR processes, ensuring service excellence and continuous improvement. Your role involves strategic partnership with stakeholders, managing escalated issues, maintaining compliance, and contributing to HR projects. You will be instrumental in refining our HR systems, particularly Workday, and upholding a culture of professionalism and privacy within the team. This position is key for an HR professional dedicated to operational excellence and strategic growth.We work collaboratively as a team, we are relentless in the pursuit of excellence, we are curious and will boldly challenge the status quo if we can provide a better way, and we aim to strike a balance between process efficiency, effectiveness, and controls and compliance. We are committed to delivering accurate, timely, and insightful information with a high level of customer service, while striving to continuously improve our processes to help scale our operations to support future growth.Here's What You'll Do:Supervise all HR operational processes, implementing best practices and continuous improvement strategies.Partner with Tier 2 stakeholders to refine operational processes.Proactively assist with HR inquiries and requests from employees in the US and Canada, ensuring prompt resolutions and maintaining a superior level of service.Resolve issues encountered by the Tier 1 support team across the U.S. and Canada, ensuring efficient troubleshooting and customer satisfaction.Offer strategic guidance for HR Operations on project charters, focusing on enhancements to Workday and overall process optimization.Serve as the HR Operations delegate in the quarterly SOX security reviews, maintaining compliance and internal control standards.Strategically manage and improve the escalation process for complex inquiries through various communication channels.Curate and administer the HR Operations internal knowledge base, ensuring that FAQs and standard responses are regularly reviewed and updated on the team's site to provide accurate Tier 1 support and keep HR processes streamlined, while strategically planning for the continual relevance and accuracy of the information.Act as the primary tester for HR processes within Workday, including onboarding, goal setting, performance evaluations, talent assessments, and calibration sessions.Reflect on the current HR metrics audits (Work vs. Home Locations, Cost Center vs. Company, and Remote vs. Alternate Work Locations) to evaluate their effectiveness in maintaining data integrity and supporting decision-making.Foster a professional and customer-focused culture within the HR team, emphasizing the importance of employee privacy and confidentiality.Participate in strategic HR projects as assigned.Additional duties as may be assigned from time to time.Here's What You'll Bring to the Table:BA/BS degree or equivalent is required; equivalent work experience required.At least 5 years of experience with HR Shared Services or similar roles.Proficiency with HRIS systems like Workday and case management tools like ServiceNow.Demonstrated ability to build strong collaborative relationships and influence stakeholders without compromising on quality or outcomes.Outstanding written and verbal communication skills.Ability to thrive in a matrix environment, displaying flexibility, collaboration, and a commitment to deadlines.Excellent organizational skills with a keen eye for detail and a results-driven approach.Proven track record of managing multiple tasks effectively and prioritizing workload.Skilled at decomposing complex business requirements into operational solutions.Analytical, critical thinking, and problem-solving abilities.High-level proficiency in Microsoft Office suite.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-DP1-

Responsibilities Location Cambridge, MassachusettsUS Job ID REQ-052298 Key Responsibilities:Document procedures, policies, troubleshooting and best practicesExecution of Peer reviews of PerkinElmer related checklists for Commissioning, Decommissioning and AIQ tasks. Escalates IT issues that are not resolved via regularly identified support channels.Manage ServiceNow requests and incidents to SLAActs as an interface between client, business and corporate IT teams.Conduct daily ticket scrums Provide weekly/monthly/quarterly/yearly agreed upon governance reports Conduct regular 1-1s with team membersWork collaboratively with the account and product managersImplements, monitors and provides technical support of customer laboratory IT environments, typically integrated with instrumentation Implements customer specified benchtop computing design and processesAdministers and assures connectivity of customer's Windows based platformConduct and maintain inventories of client systems Support of the operating system, desktop hardware and peripherals, instrument-controlled software, core desktop applications and imagining of computers Manage On-boarding, retirement and relocation of equipmentImplements Windows based security, including but not limited to: user / group permissions, file / folder permissions, group policies, local security policies, etc.Analyzes, identifies, and implements enhancements, upgrades and/or solutions to improve the overall support of the desktop platform in a timely mannerActs as the technical support contact for instrument vendorRepairing and troubleshooting instrument related computers and escalating issues to the client infrastructure teamsProvides technical support for new system validations and change management effortsCreate and maintain a physical inventory of lab equipment, PC's, software and any other information specified by the clientEnsure weekly Engineer reports are received by COB on the last business day of the weekActs as client Liaison for software/hardware related inquiries Participate in client team meetingsHire new staff, perform regular performance reviews, provide coaching as requiredWork with Delivery and Product Managers to develop and grow the service Provides support across all PerkinElmer Enterprise practices as required Act as the technical expert to handle escalations and be a mentor to junior team membersComplete administrative tasks to maintain compliance with PerkinElmer time and attendance standards and ensure employee completion Critical Skills:Excellent customer service skills complimented by an ability to listen to and interpret client requests.Ability to troubleshoot complex instrument and technology issues.Strong verbal and written communication skills.Ability to identify, track and complete tasks for multiple projects under prescribed timeframes.Knowledge of laboratory safety practices.Basic Qualifications:Bachelor's Degree5+ years of relevant technical experience in lab IT or regulated IT environment2 + years of supervisory experience in ITPreferred Qualifications:Experience in a Lab GxP environment if applicableExperience with scientific instrumentationExperience in SOP creations and change control management if applicableExperience as team lead in an IT environmentOther Requirements:Must be able to remains in a stationary position more than 25% of the timeThe person in this position needs to occasionally move inside and outside labsFrequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function. Regularly move or lift up to 25 pounds and occasionally move or lift up to 100 pounds Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position. Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printerThe annualcompensation range for this full-time position is $99,840.00 to $149,760.00 The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.PDN-9b6ad194-46fe-41dc-8adb-ee8d55451c59

Center 3 (19075), United States of America, McLean, VirginiaManager, Cyber Product Owner (Cyber Intelligence)Capital One is seeking a product owner to help deliver game-changing cybersecurity solutions based on threat, data, and design thinking. At Capital One, we believe in the values of Excellence and Doing the Right Thing. We are a technology-oriented company delivering financial products to market through modern technology and constant innovation at a massive scale. Part of that innovation is leveraging technology to deliver the best cybersecurity solutions for our business. As a Product Owner supporting the Cyber Intelligence Service, you will be accountable for contributing to and delivering upon the strategic agenda for our core cyber products to drive meaningful progress for our customers and our business. In this capacity, you will drive product vision into our development teams, translate vision into delivery objectives, provide customer-informed guidance to shape products, and work with cross-functional teams to deliver well-managed and sustainable features that bring that vision to life. You will use your deep technical knowledge and subject matter expertise in cybersecurity and systems engineering to drive impactful improvements to our cyber capabilities. What you'll do:Communicate the Intelligence delivery roadmap to our stakeholders and leverage the product vision to inspire the teamsClearly articulate and advocate target persona, customer benefit, and value of features across teamsLeverage Intelligence experience and technical knowledge of how systems work to effectively support engineering teams in delivering valueUtilize strong cybersecurity background, customer research and insights to represent the voice of the customer to the engineering team(s)Incorporate design thinking and analytics to inform product designActively participate in research or design sessions for new featuresContribute to the development of a healthy product backlog, collaborating with the Product Manager, Engineering, and Solution Architects to break down business epics, document user stories (to also include things like addressing technical debt, SRE, etc.), design details and comprehensive acceptance criteriaLead internal backlog refinement sessions to refine cyber and customer intent, prepare business epics and stories for technical breakdown and planning, and ensure requirements are well understood by the engineering teamsPrioritize the Product Backlog to maximize business and customer outcomes by balancing technical and non-technical aspects while also incorporating cyber and operational risk reduction outcomes and activitiesEnsure the timely delivery of product deliverables by staying abreast of dependencies & impedimentsAct as a technical advisor to the product manager, engineering, and other stakeholdersCollaborate across multiple cross-functional teams and the Product Owner community and play a key role in key Agile and SAFe ceremoniesSupport teams through escalation and resolution of impedimentsDrive performance and innovation with data-driven insights and a culture of continuous improvementProactively identify opportunities when key metrics on security, resilience and performance for your product (s) are not performingMaintain technical and risk credibility with your own team(s) and with partners across our technology organizationAbout you:You have excellent written & verbal communication skills with a track record of being able to explain complex concepts to diverse audiencesYou 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 developer community, customers, and business partners.You have experience leveraging Threat Intelligence to reduce risk or improve security controlsYou thrive in working in a fast paced, technologically forward leaning environment and are not afraid to push the boundaries of security capabilities.You seek to create enduring value by delivering reusable, extensible and resilient cybersecurity capabilities to address the evolving threat landscapeYou actively solve for cyber technical challenges in collaboration with engineering and architectureYou are naturally curious and stay on top of emerging trends and threats.You have a comprehensive understanding of iterative software delivery to connect effectively and in a meaningful way with software and platform engineersYou seek to understand the business and technology landscape and cross-functional dependencies to inform product vision and integration with larger organizational goalsYou are a clear thinker, thrive in working across teams, and an expert in dealing with ambiguity.You understand and track key metrics on security, resilience and performance for your product (s) and understand levers that drive these metricsYou have strong consulting and analytical skills and a risk management mindsetYou have the ability to foster collaborative, open working relationships with technology partners and other stakeholdersYou demonstrate balanced judgment in decisions and incorporate risk factors accordinglyYou have a strong bias for actionBasic Qualifications: High School Diploma, GED or equivalent certificationAt least 6 years of experience working in cybersecurity or information technologyAt least 3 years of experience in product managementPreferred Qualifications:Bachelor's Degree in Cybersecurity, Systems Engineering, or Computer Science3+ years of experience solving cyber technical challenges4+ years of experience translating business strategy and analysis into products3+ years of Cyber product owner experience2+ years of experience in technical writingExperience in regulated financial services organizations or tech companies2+ years of hands-on JIRA and Confluence experience1+ year of experience with MITRE and Cyber Kill Chain Frameworks2 or more professional certifications (SAFe PM/PO, CISSP, GIAC, CISM, CCSP, AWS Cloud Practitioner, AWS Security)?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.New York City (Hybrid On-Site): $201,400 - $229,900 for Manager, Cyber TechnicalSan Francisco, California (Hybrid On-Site): $213,400 - $243,500 for Manager, 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).

Job DescriptionAbout This RoleThe R&D IT Senior Business Analyst (BA) will play an active role in supporting GXP applications in the Clinical Sciences business area, specifically the electronic Trial Master File (eTMF). The BA has responsibility for the health and success of eTMF and related projects within a matrixed organization with direct relationships with various groups in the business as well as IT.This role requires the ability to:Monitor, manage, and ensure predictable delivery of eTMF projects in a deadline-driven, regulated environment. Act as Project Manager for small projects.Drive delivery and accountability of internal staff as well as vendors and third-party project managers. Own the quality of the project deliverables.Enable early identification and escalation of risks and issues that require assistance, attention, or executive resolution.Own the eTMF system lifecycle management process and compliance requirements.Effectively communicate system and project status to leadership; verbal or written. What You'll DoThe BA is responsible for ensuring that system compliance and project deliverables are of high quality and meets GxP compliance standards. The BA works with project teams to deliver with high quality and timely cadence. The BA will facilitate activities of Biogen-internal resources, external vendors and other partners.The key activities for this position include:Develop GxP-compliant SDLC deliverables.Document business processes and use cases.Translate business to technical requirements. Drive understanding of deliverables.Provide appropriate technical/functional software support throughout product and project lifecycles.Assist testing staff in designing test plans and test scripts to validate functional requirements.Co-author operational support documentation.Support deployment and hypercare activities.Complete other ad hoc tasks, as requested.QualificationsWho You AreAbility to operate effectively in a GxP matrix environment; team player yet able to work independently with minimal direction.Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and SaaS vendors.Excellent oral and written communication skills; able to organize and clearly present ideas in a convincing and compelling manner.Required Skills5+ years' experience as a Sr. Business Analyst, with working command of requirements engineering, analysis tools and techniques.Highly experienced in SDLC management and iterative systems development methodologies with emphasis with eTMF system management.BA or BS in Computer Sciences or Data Sciences required.IT System Owner (Product Manager) - change and release management, validation planning and execution, and system lifecycle managementFamiliarity with GxP, CFR 21 Part 11 and systems validation.Knowledge:Regulatory audit and inspection supportTools and Technology awareness: IQVIA eTMF, Veeva eTMF, CAPA/Deviation management, system management reviews, ServiceNow, ALM VERA, Document Management system, MS Project, MS Visio and standard MS Office products.Preferred SkillsAdvanced degreeCBAPAdditional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bd5722a-dca1-4d24-8fe2-23077e5c72c2

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.Culture is key and all Bicycle employees actively embrace and role model our company values:WeareAdventurous.We believe it'sthewaytodeliverextraordinaryresultsforourpatients.WeareDedicatedtoourMission.Youcan'tchangetheworldifyoudon'thavedetermination.WeareOneTeam.Weonlysucceedwhenweworktogether.Job DescriptionSenior Manager, Quality provides Quality oversight for Bicycle's development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the team tasked with product development, the position serves as a Quality and compliance business partner, engaging with multiple collaborators. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. The position will be a member of the Development Quality group, reporting to the Head of Development Quality.Collaborate with global program teams to ensure protocol, procedural, GCP / regulatory compliance and inspection readiness throughout all stages of product developmentDevelop and maintain quality dashboards/ metricsAnticipate, identify, communicate, and manage quality issues to resolution, including escalation to key stakeholders across the business.Contribute during internal cross-functional meetings to review and document oversight of company Quality initiatives.Support applicable change management pertaining to new and/or evolving global regulations, and anticipate any changes that may impact the development strategies for programsSupport the review of key clinical trial documents (INDs, manuals, study plans, etc.) for compliance with existing policies and procedures, ICH GCP and applicable global regulatory requirementsParticipate in the planning, conduct, management, review, documentation, communication and follow up of internal and external quality audits, vendor qualification and assessmentsContribute to the development and delivery of Quality training modules for internal company employees enabling a culture of quality throughout companySupport preparation for, and coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspectionsSupport vendor selection/qualification activities (including but not limited to vendor audits and maintenance of preferred vendor list)Provide expert quality consultation to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of applicable regulations. Identify and partner with key collaborator functions and business partners as appropriate.Assist development team business partners with development and documentation of CAPAs and effectiveness checks, as applicable.Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.QualificationsThe position requires a Batcheler's degree in a science or healthcare fieldDemonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GCP quality/compliance roleKnowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS)Knowledge of GLP /GCLP preferredStrong familiarity with eTMF requirementsExperience conducting audits, reviewing audit reports and following up on CAPAsExperience leading quality event investigations/ root cause analysisA thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturingHighly collaborative, strong relationship building skills with high level of integrity.Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutionsDemonstrated ability to work proactively using solid communication and influencing skills to effectively execute program goalsExhibits flexibility and is a self-starter with a strong attention to detailDemonstrated ability to adapt working style to those of others for effective communication; able to multi-task and support multiple teams with varying levels of complexityAble to work effectively in highly complex and fast-paced environmentsStrong organizational and time management skillsFamiliarity with Electronic Document Management (EDM) systems and Microsoft Office suitePosition requires both domestic and international travel up to 10% of timeAdditional InformationFlexible working environmentCompetitive reward including annual company bonusMedical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the CompanyHealth and Dependent Care Flexible Spending Accounts401(k) plan with a 4% Company match and immediate vestingEligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional daysEmployee assistance programEmployee recognition schemes10 Company holidaysCompetitive Family Leave PolicyEligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.All your information will be kept confidential according to EEO guidelines.Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.

Harvard UniversityPosition Title: Sr Analyst Process ImprovementReq ID: 65600BRSchool or Unit: Harvard Kennedy SchoolDescription: Job SummaryThe Senior Analyst for Process Improvement seeks to improve, streamline, and document the standard operating procedures underlying the executive education programs of the Bloomberg Harvard City Leadership Initiative (BHCLI). There is a great deal of work to be done to evolve the systems and workflow that undergird the work of these teams to effectively and efficiently meet the associated needs of all stakeholders - involving coordination across teams as well as with administrative and finance teams at both the Bloomberg Center for Cities and Harvard Kennedy School (HKS) Executive Education. The Senior Analyst will play a key role in managing and delivering on projects to achieve these ends - and will analyze, design, and develop new and improved processes and workflows. This is a term position because we are at a key inflection point of scale and seek to align processes across HKS teams as much as possible.Over the last two years, the Bloomberg Harvard City Leadership Initiative programming has grown in size and complexity, building and expanding on the forty years of operational Executive Education expertise resident within the Kennedy School. City leaders now participate in ten programs over multiple locations and online, involving faculty from several schools, and more than 570 participants. Participants engage both as individuals and as teams representing cities. The successful execution of the programs requires delivery of services provided across four highly integrated teams: Executive Education, City Support and Student Engagement, Curriculum Development, and Impact and Evaluation. Collectively these teams aim to come together to create a seamless experience and support for participants (city leaders), faculty, the donor, and each other.As the Senior Analyst, you will work closely with the broader Bloomberg Harvard City Leadership Initiative, Bloomberg Philanthropies and Executive Education to identify, lead and implement improvements to standard operating procedures across Bloomberg programming, sharing excellent practices with HKS Executive Education as well.Position DescriptionKey functional responsibilities include:Process improvement and business analysisDocument and evaluate existing processes, operations and services; identify pain points, inefficiencies, risks, and opportunities for automation, streamlining, and future business practices to identify high impact areas for improvement.Assess and document user requirements.Serve as a cross-functional resource, securing input and fostering ongoing communication across teams in developing process and operational improvements.Recommend workflows, configurations, and designs; assess impact of proposed changes.Design tests of change, as appropriate, to refine plans for change.Build tools, spreadsheets, Salesforce configurations and other solutions as needed.Document and develop training materials. Measure success to ensure that new processes are indeed improvements.Project managementDevelop and manage project pans, track ongoing progress, and perform project resourcing and budgeting (money and/or people).Effectively communicate status, collaborate, and problem-solve with relevant stakeholders.Identity, mitigate, and manage risk on projects.Revise project planning as needed.Manage partners, internal or external vendors, and developer to deliver products, tools, applications and/or support as needed. For projects - ensuring execution proceeds with the rigor, discipline, and adaptability needed for success.Provide regular updates to BHCLI and HKS Executive Education leadership, ensuring transparent communication and the ability to leverage recommended improvement across the full array of HKS Executive Education programming. Key projects may include:Admissions workflow. Define requirements for and develop improvements to the process flow for admissions including improvements to content and communication, usability across mayors and teams, user testing, reporting, and communications with donor. SOP and training documentation. Identify gaps and develop new materials as needed. Consolidate and ensure ease of access in applicable project management tools. Update Salesforce documentation to reflect changes and updates since initiative moved from the Executive Education-instance to the Center-instance. Evaluation data. Harmonize and optimize workflow, processes and feed of data across Executive Education and Bloomberg Center organizations. Ensure key stakeholders, including faculty, receive timely and useful data. Checklists and workflow documentation. Revamp checklists and program templates to reflect the most recent realities of initiative programming in New York City, Cambridge, and online. Ensure comprehensive across entire initiative: clarify roles and responsibilities in functions across Executive Education, City Support and Student Engagement, Curriculum Development, and Impact and Evaluation.Correspondence templatization. Provide updated and accurate templates for a range of correspondences including onboarding, information for participant support and administrative staff, Canvas invites, and various follow ups.Participant travel. Develop documentation and guidelines for participant-related travel. Surface need for policies, workflows, and escalation protocols. Data to donor. Simplify, automating where possible, processes for sending data to donor or other collaborators about participation, program design, and other agreed-upon coordination points. Develop templates for standard for communication of key items (i.e. admissions decisions, curriculum preview, etc.).Spread Innovation. Cross-check planned improvements with HKS Program Delivery leads, to enable improvements and innovations to spread broadly across BHCLI and HKS Executive Education. Create and exercise a routine cadence for exchanging improvements and testing in different programs.Basic QualificationsBachelor's degree and a minimum of 5 years of directly related program management experience.Additional Qualifications and SkillsIf you have some, but not all, of the following qualifications and skills, we encourage you to apply; we value employees with a willingness to learn.Knowledge of Customer Relationship Management Systems; Salesforce configuration skills.Intimate knowledge of the Bloomberg Harvard City Leadership Initiative and HKS Executive Education systems and procedures. A demonstrated record of success in leveraging technology in the delivery of service operations.Strong organizational and communication skills. Project management experience. Demonstrated success in launching, implementing, or improving systems or standard operating procedures.Strong team-builder with an ability to build productive relationships and lead work across all levels across a diverse organization.Skill in managing multiple diverse activities simultaneously, while operating with speed, accuracy, and strong judgment.Proven creative problem-solving and analytical skills.Additional InformationThis position is a fully benefits-eligible term appointment ending June 30, 2025, with possibility of renewal.This is a part-time position, required to work a minimum of 21 hours per week. Learn more about our work culture and see yourself at Harvard Kennedy School.We regret that the Harvard Kennedy School does not provide visa sponsorship.Harvard University requires pre-employment reference and background checks. Harvard University is committed to supporting a healthy, sustainable learning and working environment.This is a hybrid position based on our campus in Cambridge, MA. As a campus-based institution, we place a high value on the in-person experience, cross-team collaboration, and strong community building in order to create a vibrant campus for our students, faculty, staff, and research fellows. The position is required to work in-person on campus a minimum of 1 day per week during the academic year, or as determined by business need. Specific days and schedule will be determined between you and your manager.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.Salary Range: $74,200 - $126,200Note: Starting salaries typically fall in the lower half of the salary range; however, they are ultimately determined by the scope of the position, the candidate's relevant experience, and internal equity.About UsAbout the Bloomberg Harvard City Leadership InitiativeThe Bloomberg Harvard City Leadership Initiative-the flagship program of the Bloomberg Center for Cities at Harvard University-is a collaboration between Harvard Kennedy School, Harvard Business School, and Bloomberg Philanthropies to equip mayors and senior city officials to tackle complex challenges in their cities and improve the quality of life of their residents.Launched in 2017, the Initiative has worked with 465 mayors and 2271 senior city officials in 524 cities worldwide. The Initiative advances research and develops new curriculum and teaching tools to help city leaders solve real-world problems. By engaging Harvard graduate students in research and field work, the Initiative supports current city leaders while investing in future generations. The Initiative also advances the field of city leadership through teaching, research, and new curricular materials that help city leaders drive government performance and address pressing social problems.About the Bloomberg Center for CitiesFounded in 2021 with Bloomberg Philanthropies, the Bloomberg Center for Cities at Harvard University is a fast-growing global community committed to improving public management, leadership, and governance. The center's unprecedented cross-Harvard collaboration unites expertise focused on cities across disciplines and schools to produce research, train leaders, and develop resources for global use.Building on Harvard faculty research and teaching and Mike Bloomberg's ongoing commitment to cities-and belief in their ability to drive change around the world-the center is designed to have a widespread impact on the future of cities, where more than half of the world's people now live, by informing and inspiring local government leaders, scholars, students, and others who work to improve the lives of residents around the world.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.Department Office Location: USA - MA - CambridgeJob Code: 358057 Admin Pro/Indiv ContribJob Function: General AdministrationWork Format: Hybrid (partially on-site, partially remote)Sub Unit: ------------Salary Grade: 057Department: Bloomberg Center for CitiesSalary Range: $74,200-$126,200Union: 00 - Non Union, Exempt or TemporaryTime Status: Part-timePre-Employment Screening: Education, IdentityCommitment to Equity Diversity Inclusion and Belonging: Harvard Kennedy School's Mission and Commitment to Diversity, Equity, and Anti-RacismAt Harvard Kennedy School, fostering a diverse and inclusive community where everyone feels they belong is a matter of basic fairness consistent with our core values as an institution. It is also essential to our mission of improving public policy and leadership-because recruiting the best people and creating an environment where they can thrive make us better at what we do, because we learn more from people with different perspectives, and because we work in diverse groups and serve diverse societies.Learn more about Harvard Kennedy School's commitment to Diversity Equity, and Anti-Racism.EOE Statement: We 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.PI239885340