Project Management Salary in Florham Park, NJ

RESPONSIBILITIES:Kforce client located in Florham Park, NJ is seeking an experienced Communications/PR & Investor Relations Manager to join their growing team. This is a direct hire and hybrid opportunity. Summary:Reporting to the Chief Executive Officer, the Communications/PR & Investor Relations Manager will lead the planning, management, and execution of all investor relations and communications activities at the Company. This role will be critical in furthering the client's mission by conveying the company's vision, strategy, values to both internal and external communities.Responsibilities: Develop, integrate, and execute comprehensive investor relations and corporate communications strategies Continue to evolve the communications strategy to align with changes to the business Lead a strategic communications plan that advances business goals and resonates with key audiences externally and internally Acts as liaison between the company and the public Facilitates the company's quarterly earnings calls, which may include creating and reviewing the agenda, developing the materials and speaking notes/storyline, and other related tasks Build and maintain strong relationships with current and potential investors; provide analysts and investors with accurate and timely information about the company's strategy In partnership with executive leadership team, HR, and PR/IR firm, manage and further develop our social media strategy and website Manage external agencies and vendors that are supporting investor relations and corporate communications activitiesREQUIREMENTS: Bachelor's degree in Public Relations, Marketing, Corporate Communications, Business, or related field required; MBA or other advanced degree in a scientific area is preferred At least five years of business experience is required - 2 years minimum in the biotech industry required Excellent verbal and written communication skills Excellent interpersonal and networking skills with a variety of personalities and positions Ability to convert complex financial information into understandable text The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future. We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave. Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law. This job is not eligible for bonuses, incentives or commissions. Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

The Vice President of Medical Science serves as the Global Medical Leader, overseeing compounds targeting rare diseases and assuming the crucial responsibility of Medical Monitor for clinical studies. Responsibilities include providing comprehensive medical and scientific guidance, ensuring alignment of company clinical programs with the overarching Global Clinical Development Plan for assigned assets. Extensive interactions with Regulatory Authorities, including the FDA, as well as engagement with clinical experts and investigators, are integral to the role. Collaboration with functions such as Project Management, Regulatory Affairs, and Clinical Operations is essential to drive seamless integration of development plans, medical strategy, and operational execution. This role is both tactical and strategic, requiring hands-on involvement while shaping long-term vision and strategy. RESPONSIBILITIES  Leading the design and execution of clinical trials specific to rare diseases, ensuring adherence to regulatory standards and ethical guidelines. Developing comprehensive medical strategies tailored to address the unique challenges and considerations of rare diseases, including patient recruitment, endpoint selection, and data analysis. Overseeing safety monitoring activities, including the review and analysis of adverse events, safety signals, and risk management strategies specific to rare diseases. Providing medical oversight throughout all phases of clinical development, including protocol development, site selection, patient monitoring, and data interpretation. Coordinating the preparation of clinical study reports, investigator brochures, and other regulatory documents relevant to rare disease clinical trials. Leading the dissemination of study results through publications in peer-reviewed journals, presentations at scientific conferences, and engagement with medical and patient advocacy communities. Collaborating with cross-functional teams including Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Medical Affairs to ensure alignment of medical objectives with broader organizational goals. Coordinating the preparation of clinical study reports, investigator brochures, and other regulatory documents relevant to rare disease clinical trials. Establishing and maintaining relationships with Key Opinion Leaders (KOLs), external experts in the field of rare diseases to gather insights, facilitate investigator-initiated studies, and advance scientific knowledge. Staying abreast of advancements in the field of rare diseases through ongoing education, participation in scientific meetings, and engagement with professional networks to ensure the application of best practices and innovative approaches in clinical development. Developing and delivering educational initiatives for internal stakeholders, investigators, and patient communities to raise awareness and understanding of rare diseases and ongoing clinical research efforts. Evaluate external assets for potential in-licensing or acquisition, considering medical value, strategic alignment, and therapeutic relevance. Collaborate with business development teams to provide medical insights and support due diligence assessments. Conduct comprehensive evaluations of internal pipeline products, analyzing clinical data, market potential, and competitive landscape to inform strategic decisions. Provide recommendations for resource allocation, prioritization, and portfolio management to maximize asset value and strategic alignment. Other duties as assigned. MINIMUM JOB REQUIREMENTS  Qualifications Medical degree (MD or equivalent) with board certification preferred. Minimum of 14 years of experience in the pharmaceutical industry required; 5 years of continuous clinical development experience in rare diseases, serving as a medical expert/medical monitor for Phase 2 and/or Phase 3 studies, or as a clinical leader for a product in Phase 2 and/or Phase 3. Substantial experience in clinical development within the pharmaceutical or biotechnology industry, with a focus on rare diseases. Proven track record of successful leadership in designing and executing clinical trials for rare diseases, resulting in regulatory approvals. Strong understanding of regulatory requirements and guidelines governing rare disease drug development. Ability to write regulatory documents in clear language. Thorough knowledge of Good Clinical Practices (GCPs) and regulatory reporting requirements, particularly in the US and internationally, for product safety is necessary. Experience in writing and reviewing scientific and clinical research reports for regulatory submission and scientific publication is preferred. Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. Demonstrated ability to think strategically, analyze complex medical data, and make informed decisions. Commitment to continuous learning and professional development in the field of rare diseases. Ability to travel up to 25%, including international travel (e.g., to Japan), may be necessary. Competencies Deep understanding of rare diseases, including their pathophysiology, natural history, and clinical manifestations, is essential. Strong clinical knowledge and experience in diagnosing and managing rare diseases. Comprehensive knowledge of drug development processes, including clinical trial design, regulatory requirements, and safety monitoring procedures specific to rare diseases. Familiarity with orphan drug regulations and incentives is also important. Ability to think strategically and develop comprehensive medical strategies to address the unique challenges associated with rare diseases. This includes identifying innovative approaches to patient recruitment, endpoint selection, and data analysis. Strong leadership skills are essential for guiding cross-functional teams and driving the successful execution of clinical development programs. Ability to inspire and motivate team members toward common goals. Excellent communication skills, both verbal and written, are crucial for effectively communicating complex medical concepts to diverse stakeholders, including internal teams, external experts, regulatory agencies, and patient advocacy groups. Ability to collaborate effectively with cross-functional teams, including Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, is essential. Ability to foster a culture of teamwork and collaboration to achieve shared objectives. Strong analytical and problem-solving skills are necessary for identifying and addressing challenges that arise during the clinical development process. Able to quickly analyze data, identify trends, and develop solutions to overcome obstacles. Committed to upholding the highest ethical standards and ensuring compliance with regulatory requirements throughout the drug development process, prioritizing patient safety and data integrity at all times. Ability to adapt to changing priorities, timelines, and circumstances is critical in the fast-paced environment of clinical development. Commitment to continuous learning and professional development is essential for staying abreast of advancements in the field of rare diseases and emerging trends in clinical research methodologies. Other Requirements This position has significant managerial and decision-making authority. Ability and willingness to travel approximately 25% of the year both domestically and internationally Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month ESSENTIAL PHYSICAL REQUIREMENTS  Ability to articulate clearly and conduct verbal presentations with large and small audiences. Ability to travel via automobile and/or airplane. Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time. Ability to operate a computer keyboard and telephone. Ability to sit for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifteen (15) pounds. To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications. DISCLAIMER The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.  You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. EEO  Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Clinical Development

The Senior Trial Manager, Clinical Operations is responsible for conduct of global clinical studies.  With minimal oversight, manages CRO and vendor performance to ensure that clinical studies are completed in accordance with contract specifications and management’s expectations. RESPONSIBILITIES  Oversee and manage all operational aspects of phase I – IV global clinical trials in order to achieve a high quality product for the marketplace and business success for Shionogi Inc. Manage external partners, consultants, vendors and budget to ensure the timely and cost-effective implementation of clinical trials. Coordinate the assessment of CROs and preferred vendors for implementation of clinical development plan. Review contracts, work orders and invoices prior to submission to senior management for approval. Establish and maintain effective communication and collaboration with functional area peers including Pharmacovigilance, Drug Supply, Quality Assurance, Regulatory Affairs, Legal, Medical Writing, Biostatistics and Data Management to meet program objectives and support achievement of goals. Responsible for resource requirements (time, financial, manpower) within Clinical Research and management within agreed upon parameters. Responsible for completeness and accuracy of the study synopsis, protocol, case report and informed consent forms, clinical study reports, Annual Reports, and IB. Responsible for leading protocol and study specific clinical and operational meetings. Contribute to and support selection of all study-related vendors. Specific Duties Accountable for working closely with Shionogi Biometrics, Data Management, Pharmacovigilance and the CRO (when appropriate) to complete data management and bio-statistical analysis and oversee adherence to study timelines and data quality. Oversight includes the following areas: query resolution, logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File. Responsible for initial RFP obtainment and contributes to CRO/vendor selection Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs); as well as oversee scope change negotiations. Responsible for negotiating site CTAs in conjunction with the Legal Department and CRO. Responsible for patient recruitment and retention plans Responsible for the set-up of all third party vendor specifications (ie. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables. Responsible for collecting, preparing and reviewing regulatory documentation for IRB submission prior to study start-up. Responsible for participating and presenting at Investigator Meetings. Responsible for program level budget forecasting and quarterly review. In conjunction with Drug Supply, responsible for assuring sufficient clinical drug supply is packaged, available and shipped to sites for study start up, and that sufficient supply are maintained during the study. Responsible for assuring accurate drug accountability/reconciliation for IP issued during the study to the site and at the end of the study. In conjunction with CRO responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.). Responsible for preparing and/or presenting executive management slide decks. MINIMUM JOB REQUIREMENTS  BA/BS in life sciences or equivalent; or RN/BSN. Advanced degree or certification preferred At least 6 – 8 years of clinical research experience, with a minimum of 4 years having effectively led a project from inception to completion coupled with demonstrated ability to hold team members accountable with minimal oversight. Demonstrated expertise in daily oversight of CRO relationships and activities and a track record for completing trials on time and within budget. Knowledge of pharmacokinetics and pharmacodynamics with other supportive scientific and/or medical background. Experience and knowledge dealing with Phase 1 studies is an advantage. Significant knowledge of pharmaceutical industry, drug development and regulatory processes in order to maintain compliance with all applicable regulatory guidelines, GCP and Company SOPs and policies. Proficient computer skills and knowledge of standard office software. Ability to travel 10%-15% including possible international travel. PREFERRED SKILLS & EXPERIENCE  Previous experience as a Clinical Research Associate preferred, but not mandatory Strong written and verbal communication skills along with excellent interpersonal skills. Able to make effective presentations across functions and to senior management. Demonstrated ability to resolve multifaceted problems and lead multiple projects of diverse scope, analyze data and exercise sound judgment. High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines. Work comfortably within a fast-paced and dynamic work environment and ability to embrace change. Ability to work cross-culturally and lead by example in establishing a close partnership and maintain flexibility in a cross-cultural environment.  ESSENTIAL PHYSICAL REQUIREMENTS  Ability to articulate clearly and conduct verbal presentations with large and small audiences. Ability to travel via automobile and/or airplane. Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time. Ability to operate a computer keyboard and telephone. Ability to sit for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifteen (15) pounds. To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications. DISCLAIMER The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.  You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. EEO Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.  Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Clinical Development

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases. We have licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Phathom currently markets VOQUEZNA® (vonoprazan) tablets for the treatment of Erosive GERD and associated heartburn in adults, as well as VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. In addition, the company is actively investigating the use of vonoprazan as a treatment for Non-Erosive GERD, with a New Drug Application currently under review by the FDA and a separate Phase 3 trial planned to initiate in 2024.We believe we can change the status quo of treatment for acid-related disorders and have assembled a team of seasoned GI and pharmaceutical industry experts with deep expertise in developing blockbuster therapeutics, including anti-secretory agents. Our team of highly driven professionals are passionate in our mission to address unmet needs for patients and improve their quality of life. Phathom is looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced environment and contributing to our growth.The Manager, Investor Relations and Business Development will be responsible for supporting all operational activities related to the function including coordination of investor events, providing investor intelligence, monitoring analyst perceptions, crafting strategic messages, and assisting with relevant business development transactions. This role will have the opportunity for exposure to members of the C-suite and will be privy to core elements of company strategy. We are seeking candidates with strong communication skills, analytical acumen, attention to detail, and interest in being fundamental to the success of the overall organization. We welcome candidates with various background experience, with a focus on those driven to learn and excel.ACCOUNTABILITIES:Supporting the ongoing refinement and positioning of strategic external messagesAssisting in the development of materials required for quarterly earnings calls and board meetings Maintaining a pulse on biotech/pharma capital markets, investor sentiment, and peer messagingSupporting the coordination of all investor events (e.g., conferences, roadshows, fireside chats)Preparing management for investor interactions as the primary source of account intelligenceAnalyzing and drawing actionable insights from data (e.g., industry deals, stock performance)Owning the latest understanding of PHAT's shareholder base (i.e., using reporting and surveillance)Performing in-depth reviews of wall-street analysts' research reports and valuation modeling, including monitoring of assumptions and resulting consensus estimatesMonitoring business development transactions and competitive activity across the industryAssisting in the execution of relevant corporate transactions by providing supporting information (e.g., valuation estimates, due diligence materials, ad-hoc deal analytics) EDUCATION & EXPERIENCE:Bachelor's degree in finance, business, engineering, or a related field; MBA preferredAt least 5 years total working experience across biotech, pharmaceuticals, strategy consulting, management consulting, or data analytics related roles; public company exposure preferredPrevious roles in IR, commercial analytics, or the finance function are advantageous, but not required; strong aptitude for learning and growth potential prioritized Exceptional oral and written communication skills, including the ability to simplify and explain complex topics to various audiences (e.g., financials, modeling/analytics, scientific data)Ability to craft clear, concise, and visually appealing messages through presentation building; proficiency in Microsoft PowerPoint requiredFamiliarity with financial concepts and model building (e.g., accounting, DCF valuation, forecasting); proficiency in Microsoft Excel requiredExcellent organizational skills with an ability to effectively coordinate multiple projects, prioritize based on criticality, and deliver quicklyCapacity to digest data sets, organize information, draw conclusions, and predict implications

ADP is hiring a Change Management Specialist **This is a hybrid role based out of our Roseland or Florham Park, NJ office. Qualified candidates must reside within commutable distance to either location.** Strategist. Communicator. Facilitator. As a member of ADP's Commercial Operations Sales Enablement team , you will leverage your entrepreneurial spirit and consultative approach to orchestrate the people side of change introduced by the Commercial Operations function's most complex and transformative initiatives. With your organizational savvy, and solid knowledge of business processes, systems technology, and organization structures, you will drive faster adoption, higher utilization and increased proficiency for initiatives that position ADP for continued growth.Responsibilities:With your robust and diverse toolbelt of change methodologies and frameworks and passion for helping people thrive, you will partner with initiative leads and cross-functional working teams to:Assess change management needs for assigned initiatives and design and execute change management activitiesIntegrate change management activities into initiative project plansDefine adoption and utilization metrics; establish success measures and recommend incentives that promote, reinforce, and sustain changeDevelop communications, talking points, FAQs and presentations for a range of audience (front-line associates, front-line leaders, and senior leaders)Leverage ADP's proprietary change management HeaRT methodology and toolset to roll out change management efforts Skills & Qualifications:If you are a pragmatic, forward-focused, creative, independent thinker who:Has 5+ years in a formal change management role, preferably in a Technology organizationCombines strong, concise written and oral skills with a "user-centered" communication styleIs exceptionally organized with a strong attention to detailUnderstands management processes and systemsUses intermediate Excel and PowerPoint capabilities to analyze and present data and metrics to gain alignment/buy-in on priorities and decisions in a highly-matrixed environmentSolidly understands enterprise systems such as Salesforce, SAP, Sales Enablement and Operations platforms, etc.Is competent in agile methodologies (e.g., Scrum, Kanban, SAFE, etc.)Strong executive presence to be able to navigate ADP's leadership....then come join our team!Preferred Qualifications:A college degree is great but not required. What's more important is having the skills to do the job. Other acceptable experiences could include:Experience with Change Management.Experience with Sales Engagement Platforms helpful.At least two years' experience in a similar role.Exceptional leadership, organizational, and time management skills.Strong analytical and problem-solving skills.Excellent interpersonal and communication skills.Diversity, Equity, Inclusion & Equal Employment Opportunity at ADP: ADP affirms that inequality is detrimental to our associates, our clients, and the communities we serve. Our goal is to impact lasting change through our actions. Together, we unite for equality and equity. ADP is committed to equal employment opportunities regardless of any protected characteristic, including race, color, genetic information, creed, national origin, religion, sex, affectional or sexual orientation, gender identity or expression, lawful alien status, ancestry, age, marital status, or protected veteran status and will not discriminate against anyone on the basis of a disability. We support an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance.Ethics at ADP: ADP has a long, proud history of conducting business with the highest ethical standards and full compliance with all applicable laws. We also expect our people to uphold our values with the highest level of integrity and behave in a manner that fosters an honest and respectful workplace. Click https://jobs.adp.com/life-at-adp/ to learn more about ADP's culture and our full set of values.

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases. We have licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Phathom currently markets VOQUEZNA® (vonoprazan) tablets for the treatment of Erosive GERD and associated heartburn in adults, as well as VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. In addition, the company is actively investigating the use of vonoprazan as a treatment for Non-Erosive GERD, with a New Drug Application currently under review by the FDA and a separate Phase 3 trial planned to initiate in 2024.We believe we can change the status quo of treatment for acid-related disorders and have assembled a team of seasoned GI and pharmaceutical industry experts with deep expertise in developing blockbuster therapeutics, including anti-secretory agents. Our team of highly driven professionals are passionate in our mission to address unmet needs for patients and improve their quality of life. Phathom is looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced environment and contributing to our growth.The Senior Product Manager, Consumer/Patient Marketing will be a key member of the brand marketing team driving the development and execution of consumer/patient strategies. This position will help drive the growth of a new branded product.Accountabilities:Support development of strategies and tactical plans to support unmet patient needs and drive brand uptake.Drive development and execution of consumer marketing tactics to generate market differentiation and patient demand.Partner with multiple agencies to produce deliverables on strategy, within timelines, on budget, and measures outcomes across multiple channels.Collaborate with market research and analytics teams to develop research stimuli and manage project plans.Ensure research insights are implemented within tactical execution.Coordinate key performance indicators / metrics to enable performance reporting.Execute rep-delivered educational materials to support initiation of new patient starts.Manager development of multiple marketing assets through the LMR process.Day to Day contact for key tactical projects including creative brief approvals, launch timeline management, and financial management.Coordinate and collaborate with cross-functional teams.Coordinate budget tracking to enable accurate financial reportingEducation & Experience:Bachelor's Degree in marketing, communications, or related field requiredA minimum of 5+ years in product marketing or advertising focused preferably on consumers or patients in the biotech / pharmaceutical industry.Demonstrated understanding of consumer/patient marketing best practices, promotional strategy, and commercial policies and practices required.Proven track record of delivering successful execution across multiple promotional channels including digital media, SEM/SEO, patient support materials, point-of-care, social media, and others.Experience with earned media and social influencer campaigns strongly preferred.Previous experience in marketing, market research and/or advertising/communications agency experience recommended.Strong understanding of project management and budget trackingDemonstrated ability to work in a fast-paced environment, managing multiple projects, and working with minimal shared services.High learning agility and ability to lead projects strategically and purposefully through ambiguity and change.

The Senior Director, Global Commercial Lead (GCL) will work closely with our Japan HQ to shape product development plans and implement global commercialization strategies in multiple therapeutic areas. The GCL is a high visibility role to lead projects of considerable value to the organization. As GCL, you will direct and coordinate cross-functional teams dispersed across Japan, US and Europe to create value for Shionogi and the patients and caregivers we serve. You will lead formation, alignment and execution of global strategies, optimizing the life cycle of the product. This will be achieved by providing global perspective and strategic direction at each step of the R&D process to improve decision making across the organization, including to senior management, and gain an overall competitive advantage in the marketplace. The therapeutic areas for this role may include Metabolic Disease, CNS and/or Rare Disease. RESPONSIBILTIES  Establish global strategy and commercialization plan for assigned products; developing and driving global commercial strategy from early development stages through the brand’s life cycle. Lead the Global Commercial Matrix Team (GCMT) to develop and implement key global commercial strategies/activities including but not limited to the following: global commercial strategic documents, customer insights, global branding, global positioning, key messages, global communications plan, and associated budgets. Interact with Regional and Global Marketing Teams and in all countries where Shionogi has established commercial operations to ensure that all key launch milestones are delivered to time, target and budget. Responsible for frequent interactions with senior management and obtaining necessary endorsement from global commercial decision-making bodies for key commercial decisions. Provide integrated, global commercial input into the Global Development Plan and other key decisions. Develop the lifecycle management strategy, adapting the plan to address best the market needs. Obtain feedback and drive consensus among key internal stakeholders on key commercial decisions, including payer/reimbursement, health outcomes, clinical, regulatory, and project management. Accountable for ensuring patient, physician and payer unmet needs and insights are incorporated into the clinical development plans and the overall Global Development Plans to ensure commercial success across all major markets. Propose areas of value creation that may be outside the single brand scope. MINIMUM JOB REQUIREMENTS  Bachelor’s Degree (MBA or graduate degree in related discipline preferred). Minimum of twelve (12) years of pharmaceutical industry experience including eight (8) plus years of direct experience in global commercial strategy and/or marketing. Global or Company product launch experience is a plus. Therapeutic area marketing experience with include Metabolic Disease, CNS and/or Rare Disease preferred. An extensive and successful track record of developing commercial strategy for early-stage compounds, and product launch experience including development and delivery of strategic launch plans. Experience in new product market analysis, developing market insights and leveraging data for optimal decision making and forecasts. Demonstrated experience setting and managing a brand P&L. Demonstrated experience working independently to lead complex projects to successful conclusion. Highly developed planning, project management and prioritization skills to lead projects. Strong track record of commercial leadership in both country (major country) and above-country roles, working in the context of a complex and highly matrix global organization, in a multi-cultural environment and leading through influence. Demonstrated experience in leading successful cross-functional teams. Competencies Strong collaborative skills and interpersonal skills including ability to communicate effectively and influence at all levels across the entire Shionogi organization. Working knowledge of the global drug development process from proof of concept. Self-starter with the ability to manage multiple tasks/assignments to demanding deadlines with minimal supervision and without compromising quality. Exceptional analytical skills, strategic thinking, creativity and problem-solving capabilities. Excellent communication and presentation skills. Fluent in written and verbal business English. Other Requirements Ability and willingness to travel approximately 25% of the year. Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 2-3 days per week. ESSENTIAL PHYSICAL REQUIREMENTS  Ability to articulate clearly and conduct verbal presentations with large and small audiences. Ability to travel via automobile and/or airplane. Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time. Ability to operate a computer keyboard and telephone. Ability to sit for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifteen (15) pounds. DISCLAIMER  The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.  You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. EEO  Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Business Development

The CompanyIncedo Inc. is a New Jersey headquartered, data, analytics, design and technology solutions firm with offices all around the globe. We work across Wealth Management, Banking, Life Science, and Hi-Tech sectors. We are a global digital transformation expert empowering companies to realize sustainable business impact from their digital investments. We focus on select emerging technologies and build domain-specific solutions which will make the biggest difference to our clients' business.Description:As a Design Trainee, you'll work with a cross-functional, highly capable team of UX Designers, researchers, product managers, and engineers, inventing and iterating end-to-end product experiences. We are looking for designers who are passionate yet capable to analyze customer behaviors and identify opportunities while being able to articulate human-centered approaches in a fast-paced environment. We're a young and passionate team committed to creating a convenient, delightful and intelligent user experience. Job Description:You will be working with our US design team, involved in the end-to-end design process for various products (mobile and web) to serve the global market audience.You will have experience in defining and communicating design guidelines to maintain competitiveness.You will influence and work to bring teams together to drive towards a singular goal of making a product design successful.You will have a chance to collaborate with cross-functional teams to define, design and deliver forward-looking solutions.You will have a chance to experience cross-platform designs (Web/App) and develop your ideas with user research, prototypes, wireframes, storyboards and evaluate your success through usability testing.Collaborate with internal and external stakeholders to test ideas and to quickly iterate on products/featuresWhat you'll getProject experience and a portfolio case study reviewed by our hiring managers to leave with.Domain expertise in either Financial Services, Telecom, or HealthcareExperience working with global teams in India and North AmericaMentorship in a team with a rock-solid Design Process Requirements:Bachelor's/Master's degree in Human-Computer Interaction, UX Design, Interaction Design, or another program with outstanding fundamental design skills and genuine interest to venture into a career in digital design. OR a UX/UI Bootcamp program0-3 years of experience designing mobile sites, web applications, SaaS platforms, or enterprise software (internships count)Good understanding of the design philosophy and practical experience in user experience design and related fields.General understanding of research methodologies.Ability to move, adapt to change, and iterate quickly. Capable of working in collaborative teams to define use cases, and requirements and deliver the best experience for millions of customers.Experience with Figma is a must.Please provide your portfolio in addition to your resume. It can be an attached soft copy or a URL. Profiles without a portfolio included will not be considered.

The Senior Director, Clinical Operations holds accountability for developing strategic objectives and overseeing the tactical implementation of global or regional clinical programs for the rare disease franchise, aiming to deliver high-quality products and ensure business success for Shionogi in the marketplace. This pivotal role involves providing input to the leadership team on global strategies and functional initiatives with financial implications for organizational performance. Additionally, the Senior Director directly manages teams and provides oversight and mentoring to project team members. Responsibilities encompass aligning clinical programs with organizational goals and regulatory requirements, fostering cross-functional collaboration, managing risks, engaging stakeholders, driving global alignment and excellence, and ensuring compliance and quality assurance across clinical programs. Through effective leadership and strategic direction, the Senior Director plays a critical role in driving success and achieving Shionogi's objectives in the clinical operations domain. RESPONSIBILITIES  Provide strategic direction for global or regional clinical programs, ensuring alignment with organizational goals and regulatory requirements. Collaborate with leadership to develop and execute plans with financial implications for organizational success. At the project/study level, identifies and develops necessary internal and external inputs to ensure that protocol designs align with scientific and regulatory standards. Engages relevant external stakeholders, such as patient advocacy groups, to ensure patient-centricity in adherence to guidelines. Foster alignment with cross-functional teams to support project strategic plans, regulatory requirements, and commercial goals. Anticipate market factors that could influence strategies and the company’s position. Collaborate with Risk Management to identify and mitigate program/study risks. Implement and monitor mitigation plans across studies to ensure compliance and minimize impact on timelines and quality. Lead the identification, selection, and management of CROs and other vendors. Serve as the operational interface with external partners to address issues and ensure timely and cost-effective implementation of clinical programs/studies. Establish and maintain effective communication with internal stakeholders and external partners. Cultivate relationships with key counterparts in functions such as Research, Regulatory, Data Management, and Commercial. Externally, interact with a diverse range of scientific external experts (e.g. regulators, CROs/vendors, consultants, investigators and industry partnerships) Drive alignment, integration, and excellence in clinical management activities on a global scale. Implement innovative procedures and establish global standards to enhance clinical trial execution. Other duties as assigned. MINIMUM JOB REQUIREMENTS  Qualifications Bachelor’s degree in a relevant field such as life sciences, pharmacy, nursing, or business administration. Advanced degrees preferred. Project management certification is desirable. Minimum of 12 years of progressively responsible experience in clinical operations within the pharmaceutical or biotechnology industry, with a proven track record of leadership in overseeing global or regional clinical programs. Extensive experience in clinical operations within the pharmaceutical or biotechnology industry, including a track record of successful leadership in developing and implementing strategic objectives for global or regional clinical programs. Demonstrated leadership capabilities with experience in directly managing teams and providing oversight and mentoring to project team members. Strong understanding of regulatory requirements and industry best practices in clinical trial execution, with the ability to ensure alignment with organizational goals and regulatory standards. Excellent communication, negotiation, and relationship-building skills, with the ability to effectively collaborate with cross-functional teams, internal stakeholders, and external partners. Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable. Proven ability to identify and mitigate program/study risks, implement risk mitigation plans, and monitor their effectiveness to ensure compliance and minimize impacts on timelines and quality. Experience in identifying, selecting, and managing CROs and other vendors, with a focus on ensuring timely and cost-effective implementation of clinical programs/studies. Ability to drive alignment, integration, and excellence in clinical management activities on a global scale, implementing innovative procedures and establishing global standards to enhance clinical trial execution. Experience in maintaining compliance with regulatory standards and ensuring inspection readiness across clinical programs, including reviewing contracts, budgets, and financial reports to identify trends and issues and implementing corrective actions as needed. Flexibility to handle various responsibilities and adapt to changing priorities in a dynamic and fast-paced environment. Competencies Ability to provide strategic direction and inspire teams to achieve organizational goals. Excellent verbal and written communication skills to effectively convey ideas and information to diverse stakeholders. Capacity to develop long-term plans and align them with organizational objectives. Strong collaborative skills to work effectively with cross-functional teams and external partners. Aptitude to identify issues, analyze root causes, and develop effective solutions. Deep understanding of regulatory requirements and ability to ensure compliance across clinical programs. Skill in identifying, assessing, and mitigating risks to minimize impact on timelines and quality. Proficiency in selecting and managing vendors to ensure cost-effective and timely implementation of clinical programs. Ability to understand and navigate global regulatory landscapes and cultural nuances in clinical operations. Commitment to maintaining high-quality standards and ensuring inspection readiness across clinical programs. Flexibility to adapt to changing priorities and navigate complex challenges in a dynamic environment. Other Requirements This position has significant managerial and decision-making authority. Ability and willingness to travel approximately 10% of the year both domestically and internationally Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month ESSENTIAL PHYSICAL REQUIREMENTS Ability to articulate clearly and conduct verbal presentations with large and small audiences. Ability to travel via automobile and/or airplane. Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time. Ability to operate a computer keyboard and telephone. Ability to sit for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifteen (15) pounds. To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications. DISCLAIMER  The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.  You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. EEO  Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Clinical Development

The Senior Director of Drug Development Project Management is accountable for providing project management and drug development expertise to global project teams within the rare diseases franchise. This role involves strategic development and execution of integrated product development plans to ensure alignment with organizational goals and objectives. Collaborating with cross-functional teams, the Senior Director oversees the planning, execution, and monitoring of drug development programs, ensuring they are completed on time, within budget, and in compliance with regulatory requirements. Furthermore, the Senior Director represents Shionogi Inc. in global workstreams to ensure consistency across regions. This entails playing a pivotal role in stakeholder communication, risk management, and relationship management with internal and external partners. Additionally, this is responsible for driving the integration of key internal and external functions necessary for successful delivery of development projects. Moreover, this role is accountable for establishing, managing, and leading High-Performing Teams (HPT) within the organization, fostering a culture of excellence and collaboration to achieve project objectives. RESPONSIBILITIES Provide strategic direction and leadership in rare disease drug development project management, aligning projects with organizational goals and objectives. Develop comprehensive project plans, timelines, and budgets for drug development programs, overseeing their execution and ensuring adherence to timelines and budget constraints. Identify potential risks to project timelines, budgets, and objectives, and develop and implement mitigation strategies to address them. Manage resources effectively across projects, ensuring optimal allocation of personnel, budget, and other resources to achieve project goals. Communicate project updates, progress, and challenges to stakeholders, including senior management, ensuring transparency and alignment with organizational objectives. Ensure compliance with regulatory requirements, quality standards, and best practices in drug development project management. Monitor and evaluate project performance against key metrics and milestones, identifying areas for improvement and implementing corrective actions as necessary. Oversee relationships with external vendors, including contract research organizations (CROs) and other service providers, to ensure timely and quality delivery of outsourced activities. Drive continuous improvement initiatives in project management processes, tools, and methodologies to enhance efficiency and effectiveness. Develop and manage project budgets, tracking expenses and ensuring financial accountability throughout the project lifecycle. Collaborate with cross-functional teams including research, clinical development, medical and regulatory affairs, and commercial teams to drive successful drug development programs. Provide strategic guidance and decision support to senior management on project priorities, resource allocation, and risk management. Represent the project management function in internal and external meetings, conferences, and forums, advocating for the needs and priorities of the project management team. Act as the secretariat for key development-related meetings, including Clinical Development Leadership and departmental meetings for Clinical Operations and Medical Science, as well as future Protocol Review Committee and DSMB meetings. Build and/or manage high-performing project teams, including providing direction, coaching, and support to team members to maximize their potential and achieve project objectives. Develops working collaborations with rare disease organizations and patient advocacy groups and ensures Shionogi representation at national and international rare disease forums. Other duties as assigned. MINIMUM JOB REQUIREMENTS  Qualifications Advanced degree in a relevant field such as life sciences, pharmaceutical sciences, project management, or a related discipline. Minimum of 12 years of experience in drug development project management or related roles within the pharmaceutical, biotechnology, or healthcare industry. Extensive experience in clinical development of treatments for rare diseases, ideally overseeing an asset from early development stages through to approval and commercialization. Project Management Professional (PMP) certification required. Demonstrated experience in leading cross-functional teams and managing complex drug development projects from initiation through to commercialization or regulatory approval. Strong understanding of drug development processes, including clinical trial phases, regulatory requirements, and project management methodologies. Proven track record of successfully delivering projects on time, within budget, and meeting quality standards. Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization. Experience in strategic planning, resource allocation, and budget management for drug development projects. Proficiency in project management software and tools, as well as Microsoft Office Suite (e.g., Excel, PowerPoint, Word). Knowledge of regulatory submissions and processes, including NDA submissions, FDA regulations, and ICH guidelines. Leadership skills, including the ability to mentor and coach team members, drive change, and foster a culture of continuous improvement. Proven track record of successful leadership and management of teams, with demonstrated ability to develop and execute regulatory strategies, drive regulatory submissions, and achieve regulatory approvals. Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines, with experience in interacting with regulatory authorities. Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and regions. Strategic mindset with the ability to anticipate challenges, identify opportunities, and develop innovative solutions to achieve regulatory objectives. Competencies Demonstrated technical proficiency and deep understanding of drug development processes, including familiarity with relevant scientific and medical concepts, regulatory requirements, and industry standards. Knowledge of regulatory requirements and guidelines governing drug development processes, including FDA regulations, ICH guidelines, and GCP standards, to ensure compliance throughout the project lifecycle. Proficiency in project management methodologies, tools, and techniques to plan, execute, and monitor drug development projects from initiation to completion as recognized by the Project Management Institute (PMI). Ability to lead cross-functional teams, inspire collaboration, and drive project teams toward common goals while demonstrating strategic vision and decision-making skills. Proven ability to effectively interface and collaborate with multicultural development teams and management, demonstrating adaptability, cultural sensitivity, and strong communication skills to foster cohesion and drive successful project outcomes across diverse cultural backgrounds. Strong verbal and written communication skills to effectively convey project status, issues, and recommendations to stakeholders at all levels of the organization, including executive management. Capacity to think strategically and align project objectives with organizational goals, ensuring that drug development projects contribute to the company's overall success. Aptitude for identifying, analyzing, and solving complex problems that may arise during the course of drug development projects, including risk management and mitigation strategies. Ability to build and manage high-performing project teams, including providing direction, coaching, and support to team members to maximize their potential and achieve project objectives. Skill in managing relationships with internal and external stakeholders, including clinical teams, regulatory agencies, vendors, and partners, to ensure alignment and collaboration throughout the project lifecycle. Proficiency in resource allocation, budget management, and forecasting to ensure optimal utilization of resources and adherence to project timelines and budgets. Ability to adapt to changing project requirements, priorities, and environments, while maintaining focus on project objectives and delivering results in dynamic and fast-paced settings. Commitment to continuous learning and improvement, including staying abreast of industry trends, best practices, and emerging technologies to enhance project management capabilities and drive operational excellence. Upholding ethical standards and integrity in all aspects of project management, including adherence to regulatory requirements, data integrity, and patient safety. Possess strong presentation skills with the capability to tailor presentations to diverse audiences, ensuring clear and impactful communication of complex information and ideas. Other Requirements This position has significant managerial and decision-making authority. Ability and willingness to travel approximately 25% of the year both domestically and internationally Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month ESSENTIAL PHYSICAL REQUIREMENTS  Ability to articulate clearly and conduct verbal presentations with large and small audiences. Ability to travel via automobile and/or airplane. Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time. Ability to operate a computer keyboard and telephone. Ability to sit for extended periods of time – up to four (4) hours at a time. Ability to lift, tug, pull up to fifteen (15) pounds. To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications. DISCLAIMER The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.  You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. EEO  Shionogi Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Clinical Development