Executive Director jobs at Gilead Sciences - 124 jobs

* Responsible for leading all End-to-End Clinical and Commercial Supply Planning for Finished Product and Critical Input/Raw Materials Planning including internal and external Viral Vector Supply.* Partners with Commercial, Clinical, Process Development on demand forecast and supply plans for non-patient demand, clinical & commercial Vector and finished product.* Responsible for all ES&OP/S&OE governance and processes, projecting forward-looking inventory positions and financial implications to deliver target customer service levels, total costs and inventory health for Kite Manufacturing Network and C-level executives.* Responsible for all Clinical, Commercial Launch, Product Variation Management, Packaging & Labeling operations. Serves as advocate to shape CMC strategy and product decisions, deliver TechOps readiness for clinical trials and commercial launches, manages E2E process for labeling and packaging compliance with regional and global regulations.* Represents Global Supply Chain as a member of the Global Manufacturing Leadership Team/ CMC-TC seeking risk mitigation strategies across Supply Chain to ensure continuous patient supply.* PhD degree with 12+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry OR* MA / MS degree with 12+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry OR* BS / BA degree with 14+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry OR* High School Degree with 18+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry* Strong track record of clinical/lifecycle management and commercial planning in pharmaceutical or biopharmaceutical industry* Proven track record in strategic work in collaboration with Manufacturing organizations across a variety of settings and topics in the pharmaceutical or biopharmaceutical industry* Strong experience in program and operational management including communicating across the organization to align on shared goals, identifying options and facilitating decisions to enable programs to move forward, resourcing and managing teams to meet goals and deliverables* Proven ability to effectively manage complex and ambiguous projects, influence stakeholders without direct authority, effectively network across the organization and communicate with executives/senior leaders all within a very dynamic, fast paced environment* Excellent analytical, interpersonal, influencing and leadership skills will be essential* Ability to effectively communicate cross-functionally with all levels of management through exceptional verbal and written communication skills* Exemplifies a Lean/continuous improvement mindset to drives tangible operational improvements* Experience with data analytics development lifecycle and methodology to ensure strong, accurate, and reliable analytical tools and dashboards* Strong people leader with an excellent ability to motivate, coach, develop and recruit others under their direct or indirect management* Highest level of integrity and management of confidential information* Be comfortable and efficient in a demanding, fast-paced, dynamic, often fluid environment.* Passion for Kite's mission and deep desire to have a meaningful impact on patient lives Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. #J-18808-Ljbffr

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Executive Director, Global Clinical Supply Chain (GCSC) - Virology KEY RESPONSIBILITIES: The Executive Director, Global Clinical Supply Chain is responsible for leading clinical planning function within an assigned therapeutic area (TA). The incumbent is an end-to-end leader who inspires and motivates teams while leading the overall strategy supporting the GCSC function. Provides subject expertise on a diverse portfolio of development programs and different therapeutic modalities including small molecules, biologics and cell gene therapy for Gilead's global clinical trials. The Executive Director works internally with members in GCSC and other functions including Development Operations, Clinical Operations and Process Development and Manufacturing (PDM) to develop strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes end-to-end elements of clinical planning and execution from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide. FOCUS AREA: Establishes strategies to ensure uninterrupted clinical supply for the overall development portfolio, including clinical development programs and studies at all phases as well as managed access programs. May lead large complex projects within department and represent GCSC in cross-functional projects. Leads, develops and manages team, which includes recruitment, onboarding, and succession planning. Drives excellence and is accountable for setting clear goals and consistently delivering. Accountable for setting team goals in alignment with department and enterprise goals. Responsible for developing and maintaining a culture of continuous improvement. Mobilizes teams to develop plans, works cross-functionally within PDM and at the enterprise level to identify and implement best practices. Performs sponsor roles as requested. Champions clinical demand and operation planning (CD&OP) interfacing with leaders from Clinical Operations, PDM sub-teams. Manages across enterprise functions and partners to ensure on time in full delivery of investigational medicinal product (IMP). Ensures efficient and robust resource allocation for PDM sub-teams and clinical study teams. Partners across several PDM functions and with other enterprise functions to ensure the on time in full (OTIF) delivery of IMP to initiate and resupply clinical studies. Responsible for decision-making and directing the long-term vision of optimal supply chain strategies including labeling and distribution activities. Responsible for risk balancing by allocating work. Identifies and champions areas where process improvements are imperative. Drives resolution of complex issues, through partner sponsors as needed. Responsible for planning SOPs, Work Instructions, business policies and procedures to ensure GxP compliance. Influences cross-functional SOP content and reviews/approves as required. Oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication. Serves as the PDM sub-team for RFD assets, leading supply management for first in human (FIH) clinical trials. Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision. Responsible for the departmental budgeting process - forecasts clinical supply spends, estimates headcount requirements as well as department-related expenses (contractors, consultants, recruitment, project expenses, etc.). Leads TA level allocations decisions and influences and negotiates partner performance. Basic Qualifications: 16+ Years of relevant industry experience with BA/BS. OR 14+ Years with MA/MS or MBA, PHD or PharmD. Has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. The candidate must demonstrate hands-on end-to-end clinical supply knowledge and experience with clinical trials in therapeutic areas of virology while maintaining elevated, strategic oversight at portfolio level. Preferred Skills: Degree in a science-related field; MS, PharmD, or MBA desirable. Strong clinical supply management experience/knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations. Prior experience in complex virology trials is highly preferred. Proven strong and effective collaboration, influencing and negotiation skills to work successfully with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs. Demonstrated ability to collaborate and build strategic relationships with internal and external stakeholders. Possesses experience with clinical blinding practices in global studies, from Phase 1 to Late Phase. Possesses expert experience in sourcing and managing comparator drugs and other co-meds for clinical studies, and, in comparator sourcing strategy. Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses. Expert in leading through ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines. Excellent verbal, written and interpersonal communication skills are required. Must have the ability to write clear, concise and error-free documents/presentations. Must be a confident communicator and presenter to all organizational levels. Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus. Ability to effectively manage resources and timelines for multiple teams with studies of different complexities. Ability to lead or manage TA, department level and cross-functional projects. Gilead Core Values • Integrity (Doing What's Right) • Accountability (Taking Personal Responsibility) The salary range for this position is: $274,635.00 - $355,410.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. #J-18808-Ljbffr

United States - California - Foster City, United Kingdom - Uxbridge Commercial/Sales Operations Regular Gilead has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a better, healthier world for all people. We have commercialized more than 25 innovative medicines, helping to transform treatment for people living with HIV, viral hepatitis, cancer and other life‑threatening diseases. Through our ongoing bold and transformative science, we're driving innovations that have the potential to become the next generation of life‑changing medicines. We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams. Every member of Gilead's team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together. We are now hiring for the role of Executive Director, Global Value and Access, HIV. This role reports to our Global Head of Value and Access, and has responsibility for leading our value and access strategy for Gilead's HIV portfolio. Key Responsibilities Lead a high‑performing team to develop and execute robust global value and access strategies across the HIV therapeutic area (TA), including: Setting a clear direction for value strategy across the TA Providing guidance and input to strategic decisions including development, study design and acquisitions Developing new capabilities to deal with emerging threats and opportunities Oversee the generation of the global V&A strategy, integrated evidence plans, value story, and stakeholder engagement planning for TA‑specific assets Partner with Global Strategy Marketing (GSM) TA Lead to ensure alignment of V&A strategy with the global brand strategy. Partner with key markets to develop new funding streams for HIV prevention Understand potential and value propositions for pipeline concepts Ensure collaboration with cross‑functional partners (Clin Dev, Medical Affairs, Government Affairs, and other global and local commercial counterparts) to develop a comprehensive TA strategy and business priorities. Represent TA from a V&A perspective, providing a comprehensive view of the global priority Affiliates (G9) to the team and cross‑functional partners, including Clin Dev, and ensuring the payer perspective is reflected in the overall product commercial and development strategy. Guide the development and implementation of global value and access strategies for TA‑specific assets throughout the product lifecycle, from pre‑clinical to post‑launch, drawing on health economics, pricing models, payer landscapes, and global evidence requirements to maximize product value and patient access. Deliver strategic leadership as an active member of GV&A's leadership team (LT) and shaping the team's strategy, priorities, and activities. Basic Qualifications Bachelor's Degree and Fourteen Years Experience OR Masters' Degree and Twelve Years' Experience OR Ph.D. and Twelve Years' Experience Preferred Qualifications 15+ years commercial experience in the biotech or pharmaceutical industry, including some market access‑related activities Experience working at a global/regional level or in more than one country Preferred: Advanced degree in life sciences, health policy or medical degree Demonstrated ability to shape policy environment to support development of new funding streams Understanding of payer environment, including coverage and reimbursement, pricing and contracting, formulary management, HTA, and payment policy. Expertise in strategic pricing, contracting and negotiation, including innovative approaches and experience developing pricing strategies and business cases. Advanced understanding of the pharmaceutical product lifecycle, including experience with market access launch planning, execution, and drivers of value. Significant experience developing global V&A strategies, including developing global value messages, integrated evidence planning and creating tools to support implementation in key markets. Experience with early‑stage assets, including conducting commercialization assessments and providing V&A guidance into target product profiles and development plans. Proven track record managing a high‑performing team, building a distinctive team culture in a globally dispersed team, and developing people through coaching and mentoring. Demonstrated ability to lead and influence cross‑functionally while serving as a highly‑skilled facilitator, negotiator, and counselor. Experience in HIV treatment or prevention is helpful but not required Broader commercial experience beyond value and access is a plus Job Requisition ID R0044410 Full Time/Part Time Full-Time Job Level Director #J-18808-Ljbffr

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T‑cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Responsibilities Lead study concept development and execution of incidence/prevalence, burden of illness and natural history of disease assessments for business and development and early‑development indications. Provide strategic and tactical support for cross‑functional RWE development including registries and burden of illness/natural history of disease for regulators, payers and clinicians. Provide leadership and oversight of non‑interventional study protocols, regulatory documents and scientific publications. Provide excellent people leadership to the team, fostering a candid, constructive feedback culture, cultivating the team's development and investing in succession planning. Adapt performance metrics and dashboards for RWE projects to quantify and enhance impact. Provide expertise on RWE and observational research to cross‑functional teams including brand strategy teams for assigned brand/pipeline, newly launched and marketed product(s). Assess research gaps and objectives across key partners and disease areas to determine proactive RWE/observational research strategy. Possess superb communication skills with adaptability to address technical and non‑technical audiences, and comprehensive understanding of strategies to translate observational research methods and results for patient benefit. Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research. Provide RWE expertise and input for regulatory filings (e.g., BLA, sBLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications, filing procedures or pharmacovigilance/safety inquiries. Develop, execute and deploy integrated evidence generation plans, develop contingency plans, provide technical and strategic advice and meet milestones and budgets. Provide RWE leadership in scientific forums and interact with clinical investigators, thought leaders, external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs and Commercial). Benefits & Compensation Salary range: $221,000.00 - $286,000.00 Kite considers a variety of factors when determining base compensation, including experience, qualifications and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary by role), paid time off and a benefits package. Benefits include company‑sponsored medical, dental, vision and life insurance plans.* * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit ******************************************************************* Equal Employment Opportunity Statement Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. Kite Pharma 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 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, (c) consistent with the legal duty to furnish information or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. We promote and support individual differences and diversity of thoughts and opinion. #J-18808-Ljbffr

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Key Responsibilities Medical Excellence Leadership Partner with the Medical Excellence Leadership team to define and execute the global Medical Excellence strategy. Lead initiatives that elevate consistency, quality, and impact of medical engagement planning, execution, and measurement. Drive continuous improvement of Medical Affairs processes, tools, and operating models. Collaborate with other GMSO teams including Digital, Insights and Analytics, Scientific Communications and Content Strategy, and Medical Affairs Technology to build programs that leverage the connection across capabilities. Partner with Regional Medical Excellence to ensure consistent deployment and execution across the regional teams. Develop and deploy frameworks, tools, and support that help local and regional medical teams translate global medical strategy into effective engagement plans. Define standard methodologies, templates, and tools that optimize planning, execution, and measurement across all engagement channels (Field Medical, Medical Information, Digital, etc.). Collaborate with Channel Leads (digital, personal, and print) to establish clear principles for channel selection, integration, and sequencing, ensuring the right interaction at the right time for the right stakeholder. Support country and regional teams in operationalizing omnichannel approaches that align with scientific and compliance standards. Process & Capability Development Identify and improve cross‑functional Medical Affairs processes that enhance agility, effectiveness, and alignment. Lead projects to simplify workflows, clarify decision ownership, and reduce duplication across global, regional, and local teams. Partner with Learning & Development to design capability‑building programs (training, toolkits, playbooks) that embed best practices. Drive continuous improvement through feedback loops, metrics, and lessons learned from across the organization. Partner closely with cross‑functional leaders in Field Medical, Strategy and Operations, Medical Governance and Compliance to ensure process alignment and scalability. Serve as a strategic adviser to global and regional medical leadership teams to drive adoption of best practices. Lead global working groups and communities of practice that foster peer learning and consistency. Act as a change leader, influencing, communicating, and embedding a culture of excellence across the global Medical Affairs network. Measurement & Impact Define and monitor key success metrics for Medical Excellence initiatives and engagement effectiveness. Partner with analytics teams to design dashboards and scorecards that enable data‑driven decision making. Ensure that process improvements translate into measurable enhancements in scientific engagement, compliance, and stakeholder satisfaction. Worldwide Engagement Strategy Enablement Develop and deploy frameworks, tools, and support that help local and regional medical teams translate global medical strategy into effective engagement plans. Define standard methodologies, templates, and tools that optimize planning, execution, and measurement across all engagement channels (Field Medical, Medical Information, Digital, etc.). Collaborate with Channel Leads (digital, personal, and print) to establish clear principles for channel selection, integration, and sequencing, ensuring the right interaction at the right time for the right stakeholder. Support country and regional teams in operationalizing omnichannel approaches that align with scientific and compliance standards. Collaboration & Change Leadership Partner closely with cross‑functional leaders in Field Medical, Strategy and Operations, Medical Governance and Compliance to ensure process alignment and scalability. Serve as a strategic adviser to global and regional medical leadership teams to drive adoption of best practices. Lead global working groups and communities of practice that foster peer learning and consistency. Act as a change leader, influencing, communicating, and embedding a culture of excellence across the global Medical Affairs network. Qualifications 12 years of relevant experience with an Advanced degree (MS, MBA, PharmD, PhD or equivalent) in a scientific or business discipline. 10+ years of experience in Medical Affairs, preferably with global or regional leadership role. Demonstrated success in Medical Excellence, process optimization, capability building, or strategic operations. Proven track record leading cross‑functional initiatives that improve effectiveness and alignment. Experience supporting engagement strategy or omnichannel medical planning strongly preferred. Excellent communication, facilitation, and stakeholder management skills. Strong analytical mindset and familiarity with metrics‑driven performance improvement. Demonstrated ability to work effectively in a highly matrixed, global organization. Personal Attributes Strategic systems thinker, able to connect process design to business impact. Collaborative and credible partner who influences without authority. Change‑oriented leader who inspires confidence and adoption. Comfortable operating at both conceptual and tactical levels. Passionate about advancing scientific engagement and improving patient outcomes. Impact of the Role This position will help ensure that Medical Affairs operates as a strategic, insights‑driven, and impact‑focused function, fully aligned with Gilead's vision of transforming care for people with life‑threatening diseases worldwide. By embedding consistent frameworks, capabilities, and engagement excellence, this leader will help global and local teams work smarter, faster, and more cohesively, ultimately amplifying Gilead's scientific voice and medical impact. People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. Benefits and Compensation The salary range for this position is: $281,010.00 - $363,660.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. Gilead Sciences 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, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. #J-18808-Ljbffr

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID‑19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the virology therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early‑stage or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on cross‑functional core and sub‑teams. You will typically serve as a Gilead contact to and for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled in either Foster City, CA or Parsippany, NJ. EXAMPLE RESPONSIBILITIES: As needed, represent Gilead in negotiations with regulatory authorities. Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities. Represent Regulatory Affairs and may serve as Regional Regulatory Lead or Global Regulatory Lead on cross‑functional/cross‑regional Regulatory Submission Teams; provide strategic advice and guidance to Regulatory Affairs and cross‑functional leaders and teams. May participate on other Sub‑teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub‑team participation. Define the regulatory strategy for multiple Gilead products or projects. Proactively identify regulatory or related risks/issues and develop mitigation and/or contingency plans. Oversee and guide the preparation, compilation and timely filing of regulatory submissions, requiring cross‑functional interactions for commercial or investigational products. Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendments and routine submissions (e.g., Development Safety Update Reports/DSURs, Investigator Brochure/IB updates, etc.). Oversee and approve the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc. Oversee and guide labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets. Critically review documents for submission to regulatory authorities. Provide matrix management and leadership to project teams. Provide accurate and thorough input and recommendations into resource plans required to complete own deliverables. Track resources to ensure compliance with agreed resource allocation, including budgets. Ensure own work complies with established practices, policies and processes, and any regulatory or other requirements. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. U.S. Education & Experience PharmD/PhD with 2+ years' relevant experience. MA/MS/MBA with 8+ years' relevant experience. BA/BS with 10+ years' relevant experience. Significant regulatory, quality, compliance or related experience in the biopharma industry. Proven track record in effectively setting and directing the regulatory or related strategy to successful conclusion for one or more products or key markets. Experience and proven effectiveness working and negotiating with regulatory authorities. Significant experience participating in cross‑functional projects and teams with responsibilities related to clinical trials or other drug development activities. Demonstrated abilities to effectively delegate and manage others, as evidenced through past matrix management responsibilities. Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred. Knowledge & Other Requirements In‑depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets. In‑depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results. Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications. In‑depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions. Able to represent Gilead to regulatory authorities when managing standard and non‑standard negotiations. Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post‑marketing. Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Strong negotiation and conflict resolution skills. When needed, ability to travel. The salary range for this position is: Bay Area: $182,070.00 - $235,620.00. Other U.S. Locations: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans.* * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit: ****************************************************************** For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status and other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected under Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT. YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT. #J-18808-Ljbffr

Associate Director, Regulatory Affairs CMCJob Description We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site. Responsibilities: The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives. Responsible for preparing and/or overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures. Work collaboratively with cross functional matrix teams to develop a CMC submission plan in accordance with business objectives. Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies. Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Lead the preparation of risk assessments on major global CMC regulatory issues. Provides regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises. Coordinates and facilitates development of Regulatory CMC strategies with development and commercial project teams, affiliates for local meetings and interactions. Proven ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions. Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments). Ensures project teams, line management, and key stakeholders are kept apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Initiates process improvements, contributes to global process improvements, and support the development and maintenance of regulatory templates, best practices, and procedures. Coach and mentor junior regulatory CMC RA staff. Qualifications: Requires a Bachelor's degree in a relevant scientific discipline and 10+ years of experience OR (Preferred) Requires a Masters degree in a relevant scientific discipline and 8+ years of experience OR (Preferred) Requires a PhD in a relevant scientific discipline and 5+ years of experience. Candidate must have relevant experience in Regulatory Affairs CMC or other relevant industry experience. Experience in scientific/ technical field is preferred. A proven track record of developing global CMC strategies in all phases of drug development including life cycle management. Collaborative, proactive, and highly organized approach to work. Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC Regulatory activities and initiatives. Deep understanding of global regulatory requirements and guidelines. Excellent communication and interpersonal skills. The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. #J-18808-Ljbffr

Associate Director, CMC Regulatory Affairs - Biologics Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. We focus on HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. We seek to improve patient care worldwide and collaborate to achieve bold ambitions. We value leadership, inclusion, and accountability. As a member of Gilead, you contribute to creating possible, together. KEY RESPONSIBILITIES Lead CMC regulatory strategy for one or more products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation to ensure right first-time product submissions. Oversee the execution of global CMC regulatory plans, coordinating with PDM, Regulatory Affairs, and Clinical Development to manage submissions and approvals. Develop regulatory strategies and solutions for complex CMC challenges for clinical or commercial projects. Interpret and implement ICH and other global guidelines to achieve an approved/harmonized regulatory control strategy. Collaborate across CMC Regulatory Affairs, PDM, and other functional groups within Gilead. Lead CMC strategies, assess risks, and develop contingency plans for major, complex applications. Demonstrate Gilead Core Values and People Leader Accountabilities, upholding global CMC principles of integrity. QUALIFICATIONS A scientific degree with at least 10 years of relevant experience in biologics development, global CMC regulatory affairs, and CMC technical areas (BA/BS) or 8+ years with an advanced degree (MA/MS, PhD, PharmD, or MD). Proven track record in executing and implementing CMC regulatory strategies for a molecule. Knowledge of the global CMC regulatory landscape. Judgment to make timely decisions; strong strategic acumen and collaboration skills. Advanced communication and presentation skills. GILEAD CORE VALUES Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Salary range: $182,070.00 - $235,620.00. Compensation is based on experience, qualifications, and geographic location. Benefits may include bonus eligibility, stock-based incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. See ****************************************************************** for details. For jobs in the United States Gilead is an equal employment opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants with disabilities. For accommodations, contact ApplicantAccommodations@gilead.com. Other notices: Know Your Rights poster; pay transparency; and related protections apply where applicable. For current Gilead employees and contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0047307. Full Time/Part Time: Full-Time. Job Level: Associate Director. #J-18808-Ljbffr

The Associate Director, Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China) . Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. May manage direct reports.**What You'll Do**• Responsible for developing and executing global regulatory strategies for assigned projects and programs.• Support development of the preclinical and clinical development plan.• Identify and assess regulatory risks associated with product development. Define mitigation or contingency strategies.• Set strategic direction and leads global regulatory submission process with submission teams, including IND, CTA and core briefing packages.• Prepare and/or lead global regulatory submissions including IND, pre-IND meeting package, CTA.• Mentor Regulatory Managers.• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.• Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.• Provide input to Senior Management teams.• Maintain a global view as part of the whole regulatory team.**Required Skills:**• BA/BS/University degree, Life/Health Sciences preferred.• 8 years pharmaceutical/biotechnology industry experience with technical management experience.• Minimum of 6 years in RA.• Comprehensive knowledge of applicable regulations.• Experience in interpretation of regulations, guidelines, policy statements, etc.• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.• Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.• Knowledge of regulations governing the development of drugs.• Solid knowledge of GCPs and GLPs.• Direct experience in interfacing with relevant regulatory authorities (FDA).• Foster effective, positive interactions with regulatory agencies, and corporate partners.• Ability to lead and influence project teams, committees, etc. to attain group goals.• Demonstrate excellent leadership and communication skills.• Ability to represent the department in project teams, committees and external meetings.• Demonstrate strong organizational skills, including the ability to prioritize personal workload.• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.• Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.• Well organized, detail oriented, effective written and oral communication skills.• Supervisory/mentoring experience.• Ability to guide, train, supervise and prioritize workload of direct reports if applicable.• Expert knowledge and experience in gene therapy highly desirable.**Preferred Skills:**• Graduate degree.• Some international regulatory experience preferred.• Experience with biologics preferred.Job Level: Management**Additional Information**The base compensation range for this role is: -Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families *physical, financial, emotional,* and *social well-being*; including, but not limited to:* Medical, Dental, Vision, & Life insurances* Fitness & Wellness programs including a fitness reimbursement* Short- and Long-Term Disability insurance* A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)* Up to 12 company paid holidays + 3 paid days off for Personal Significance* 80 hours of sick time per calendar year* Paid Maternity and Parental Leave benefit* 401(k) program participation with company matched contributions* Employee stock purchase plan* Tuition reimbursement of up to $10,000 per calendar year* Employee Resource Groups participation We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.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. 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.We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. #J-18808-Ljbffr

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic area. You will lead various Core Labeling Working Group (CLWG), Target Product Label (TPL), and U.S. Product Information (USPI) team meetings. You will represent RA Labeling across all organizational levels relevant to assigned products and/or other activities. You will manage, oversee, review, and approve the work of a team of direct reports. You will manage complex labeling negotiations with regulatory authorities. You will communicate labeling and other relevant updates or changes to cross-functional leaders and teams. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will train cross-functional partners and teams on labeling processes, policies, procedures, and standards, etc. Key Responsibilities: Individual contributor, with potential leadership opportunities to mentor and coach others, supporting their development and career interests. Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area. Provides strategic advice and guidance to cross-functional partners and stakeholders. Leads and facilitates cross-functional labeling and related forums and meetings, such as CLWG, TPL, and USPI team meetings. Leads or otherwise contributes to key system and process improvements. Represents or otherwise oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling / safety meetings with partner companies. Oversees and guides Company Core Data Sheet (CCDS)/USPI review, approval, distribution, and tracking. Ensures updates to the CCDS are implemented in the USPI. Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories. Performs team and/or final review of ex-U.S. labeling. Manages complex labeling negotiations with regulatory authorities. Coaches and advises less experienced colleagues in completing their work and developing their regulatory capabilities. Leads or otherwise contributes to special projects that advance the capabilities of Regulatory Affairs. Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling. Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements. Preferred Qualifications: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Preferred Education & Experience PharmD/PhD with 2+ years' relevant experience. MA/MS/MBA with 8+ years' relevant experience. BA/BS with 10+ years' relevant experience. 4+ years' experience in prescription drug labeling. Significant regulatory experience in the biopharma industry is strongly preferred. Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products. Significant experience contributing to the development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple medicinal products. Experience in NDA/BLA labeling and labeling negotiations. Significant experience participating in cross-functional projects and teams. Experience authoring and implementing processes. Line management (direct reports) experience. Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred. Knowledge & Other Requirements In-depth knowledge of labeling requirements and guidance, including industry best practices and standards. Demonstrates extensive understanding of competitor labeling, strong therapeutic area knowledge, and CCDS/USPI expertise. Demonstrates ability to rapidly learn new therapeutic areas. Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects. Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing. Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications. Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Strong negotiation and conflict resolution skills. When needed, ability to travel. People leader accountabilities: Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking an Associate Director, End-to-End Commercial Supply Planner to develop and execute supply plans. This role emphasizes collaboration with regional supply chain leads, utilizing tools like SAP ERP and Kinaxis RapidResponse. Ideal candidates will have extensive experience in supply planning within the pharmaceutical industry, along with strong analytical and communication skills. #J-18808-Ljbffr

Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross‑functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for one or more high-volume and/or otherwise complex brands or therapeutic areas. You may manage, oversee, and review the work of one or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional Review Committee (PRC) meetings for complex brands. You may lead local cross‑functional process improvements or other special projects. You will provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to promotional materials with regulatory agencies. You will communicate relevant updates or changes to cross‑functional leaders and teams. EXAMPLE RESPONSIBILITIES: Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Serves as PRC Chair for one or more high-volume and complex brands or therapeutic areas. Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate. May lead local cross‑functional process improvements or other special projects. May initiate and/or contribute to global process improvements. Provides regulatory guidance on new marketing concepts, messaging, and campaigns. Represents RA Ad/Promo at Regulatory Project Team meetings. Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. Mentors RA Ad/Promo and cross‑functional team members as needed. May have one or more direct reports. Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Education & Experience PharmD/PhD 4+ years' relevant experience. MA/MS/MBA with 8+ years' relevant experience. BA/BS with 10+ years' relevant experience. For external candidates, 4+ years' experience in regulatory review of promotions for prescription drugs or other biologic products. Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug or biologic products. Significant experience contributing to the development of commercial regulatory or related strategies, leading cross‑functional regulatory activities, and representing Regulatory to cross‑functional teams for multiple products. Experience chairing/leading promotional review committees or other relevant regulatory governance committees. Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus. Line management (direct reports) experience is a plus. Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities. Experience working with external contractors supporting the work of regulatory affairs is a plus. Experience authoring and/or implementing processes. Significant experience participating in cross‑functional projects and teams. Knowledge & Other Requirements Demonstrates in‑depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects. Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications. In‑depth knowledge of promotional regulations and guidance for prescription drug and biologic products, including industry best practices and standards. Working knowledge of relevant regulatory or related systems is preferred. Demonstrates ability to rapidly learn new therapeutic areas. Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Strong negotiation and conflict resolution skills. When needed, ability to travel. Job Requisition ID R0044546 Full Time/Part Time Full-Time Job Level Associate Director #J-18808-Ljbffr

The Patient Access Solutions Support Program team strives to deliver exceptional patient treatment experiences across multiple brands and therapeutic areas. We empower patients to realize their full treatment potential through support programs encompassing HIV, Liver and Oncology products. Position Overview: The Associate Director will be part of the Patient Access Solutions team and will be responsible for developing access and reimbursement materials to support the Gilead HIV Prevention Field Reimbursement Manager (FRM) team. This role will lead the direction and execution of FRM access and reimbursement materials, resources, and tools, ensuring alignment with market access strategy to address educational needs of the patient and healthcare providers office staff. Additionally, this position will collaborate closely with internal stakeholders such as marketing, national account team, trade and FRM teams to develop FRM patient support educational materials and access and reimbursement communication and training plans to address ongoing reimbursement challenges. This position is responsible for the strategic oversight of the access and reimbursement resources for the HIV Prevention support program ensuring an effective provider experience. This leader needs to be able to design, plan, and pull through appropriate market‑leading resources and tools ensuring efficient, effective, compliant execution and manage continuous improvements on an ongoing basis. To do so, the candidate will be required to have familiarity with the relevant customer/market needs and solutions, including a strong understanding of compliance as it relates to patient support programs and Field Reimbursement Manager (FRM) teams. Key Responsibilities: Creation and Execution of FRM Materials and Tools: Partner with key internal stakeholders to create and roll‑out strategic marketing materials for the FRM team to achieve Access and Reimbursement goals. Lead effort to roll out materials to FRM team. Strategic Communications: Ensure materials are aligned with support program positioning, messaging, aimed at patients and healthcare providers, ensuring alignment with patient support experiences and strategic imperatives. Analytics: Support FRM digital resources, portals, and tools for effective support of patient and provider access and reimbursement challenges. Field Team Support and Collaboration: Collaborate with the Patient Support team, FRM team and Access and Reimbursement (A&R) colleagues to execute strategies, incorporating insights from payer landscapes, buy‑and‑bill models, and specialty pharmacy acquisition. Agency and Partner Management: Work with Patient Support team to oversee agency relationships to drive creative excellence, ensuring quality deliverables that align with market access materials. Annual Planning: Lead the annual planning process for patient and provider resources, identifying barriers to patient access and developing innovative solutions. Governance and Compliance: Collaborate with Market Access, National Accounts, Legal, Medical, Regulatory, Brand and Trade teams, to ensure a comprehensive governance process for FRM Materials and initiatives. Ensure all activities are conducted in compliance with relevant regulations and ethical guidelines related to patient access and reimbursement. Qualifications: Education: Bachelor's Degree in a relevant field is required. Experience: At least 10+ years of marketing experience with a proven track record in strategic leadership roles. Domain Expertise: Strong expertise in Patient and HCP support programs, Access and Reimbursement strategies, drug acquisition channels, and medical and pharmacy benefit design. Analytical Skills: Exceptional analytical skills with the ability to translate complex business challenges into actionable strategies. Leadership Ability: Demonstrated experience leading cross‑functional teams and influencing across the organization without formal authority. Communication Skills: Excellent written and oral communication skills, capable of interacting and building relationships at all organizational levels. Stakeholder Management: Proficient in managing various internal and external partnerships, maintaining effective relationships with agencies and vendors. In‑depth knowledge of healthcare reimbursement practices, services, technologies, and related compliance and regulatory requirements. Dealing with ambiguity Proven experience developing and fully executing patient access programs. Exceptional written, verbal and presentation skills Building and leading teams Leading without authority Project management Strategic planning and execution Analytical thinking and problem solving Comfortable with data analytics and presentation of findings Financial budget management Effective organizational management Strong organizational skills; attention to detail Proficient competency using Word, Excel and PowerPoint Ability to multitask and manage multiple parallel projects. Ability to work with minimal supervision. Job Requisition ID: R0044625 Job Level: Associate Director - Full Time #J-18808-Ljbffr

A leading biopharmaceutical company is seeking an Associate Director, Incentive Compensation who will oversee the complete incentive compensation process for sales teams. The role involves collaborating with cross-functional teams, designing compensation plans, and ensuring accurate payouts. Candidates should have over 10 years of experience in relevant fields and strong analytical, communication, and project management skills. Experience in virology and oncology is preferred, alongside a solid educational background in finance or business. #J-18808-Ljbffr

A leading biotechnology company in San Francisco seeks a Head of Biomarker Operations to strategize and execute biomarker operations across various clinical development programs. The position requires extensive experience in clinical biomarker operations, proven leadership skills, and a deep understanding of trial operations. The role includes overseeing a team to deliver high-quality biomarker data for regulatory submissions, emphasizing integration into trial design and vendor management. A competitive salary and comprehensive benefits package are offered. #J-18808-Ljbffr

A leading pharmaceutical company is seeking an experienced project manager with extensive knowledge of drug development. This role requires the ability to manage complex project deliverables and lead cross-functional teams effectively. Candidates should have a strong background in pharmaceutical project management, excellent communication skills, and experience with diverse team dynamics. A Bachelor's degree and a minimum of 12 years of relevant experience within the industry are preferred. The position offers opportunities for significant professional growth within an innovative environment. #J-18808-Ljbffr

** Why Genentech We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society. Who We Are Our Analytics & Insights team is dedicated to solving complex healthcare challenges and improving patient outcomes. This empowers business partners across Commercial, Medical, and Government Affairs (CMG) to make impactful decisions by leveraging data, analytics, and AI/ML to enable fast, targeted actions in rapidly evolving business contexts. The team fosters a unified understanding of customers, actions, and outcomes by integrating analytics and insights seamlessly into CMG's evolving digital, data, and automation platforms, creating scalable solutions and eliminating silos. The Opportunity Genentech is seeking a highly experienced and visionary leader to serve as the Executive Director of Portfolio Insights & Analytics. Reporting into the Vice President of Insights & Analytics, this critical role will be responsible for defining and executing the insights, analytics, and measurement strategy that enables strategic planning and execution across key strategic pillars including, Market Access, Patient Engagement, Population Health, and Medical. The successful candidate will lead a high-performing team of subject matter experts, setting the vision for how we use data, advanced analytics, and technology to generate impactful, measurable, and action-oriented insights in a rapidly evolving healthcare landscape. This role sits at the intersection of business strategy and cutting-edge analytical methods, shaping Genentech's ability to ensure broad and equitable patient access to our innovative medicines. Accountabilities + Strategic Insight Leadership: Architect the overarching vision and roadmap for portfolio data analytics and market research, ensuring that strategic decisions are rooted in rigorous, evidence-based insights. + Portfolio Decision Support: Lead high-impact insights and analytics programs that inform portfolio-level decisions, providing the evidence base for strategic decision making. Lead Patient, Access, Population Health, and Medical data and insights capabilities. In collaboration with Finance and the product Squads, provides strategic decision support for short and long-range revenue and opex planning. + Predictive Intelligence: Direct the development of sophisticated predictive tools and advanced analytical models to anticipate healthcare shifts, allowing Genentech to proactively shape strategies for evolving payer and provider landscapes. + Enterprise Digital Transformation: Act as a leader in Genentech's technology evolution, championing the integration of AI and advanced data science to modernize commercialization and drive market-leading competitive advantages. + Strategic Executive Partnership: Act as a principal advisor to the Vice President and other senior leaders, synthesizing complex data ecosystems into clear, high-stakes business recommendations that influence the enterprise's strategic direction. + Impact & Value Measurement: Establish and oversee comprehensive measurement frameworks to quantify the real-world effectiveness and ROI of patient access strategies, medical initiatives, and policy engagements. + Cross-Functional Synthesis: Drive a unified organizational view of the patient and provider journey by orchestrating the integration of disparate data streams across the customer engagement journey, including patient-level claims, EHR, and qualitative market research. + Organizational Talent Architecture: Build and mentor an elite team of subject matter experts, cultivating a culture of intellectual curiosity, analytical rigor, and collaborative influence that elevates the entire Insights & Analytics function. Required Experience & Expertise + Bachelor's degree in a quantitative, engineering, or scientific discipline (Economics, Business Management, Data Science, Chemistry, etc) is required. Advanced degree preferred (MBA, MS, PHD, etc) + 15+ years of progressive leadership within the pharmaceutical or biotech sectors, including at least 5 years of proven success managing high-impact, multi-disciplinary teams in analytics, business intelligence, or market research. + 10+ years of deep immersion in the healthcare ecosystem, specifically within Market Access, Patient Strategy, Healthcare Policy, and/or Portfolio Strategy, with a proven ability to link these functions to broader commercial success. + Deep understanding of pharmaceutical forecasting and measurement methodologies and demonstrated ability to strategically advise senior leadership on portfolio insights and opportunities. + Strong proficiency in leveraging complex, large-scale healthcare data-including Payer Claims (IQVIA, Symphony, Optum), EHR, Clinical Trial, and Specialty Pharmacy data-to derive predictive and prescriptive insights. + A documented track record of architecting and implementing sophisticated analytical roadmaps that have directly influenced enterprise-level business strategy and delivered measurable financial or clinical outcomes. + Fluency in the global data privacy landscape and compliance requirements (e.g., HIPAA, GDPR), ensuring the highest standards of integrity in HCP and patient-level analytics and research. + Mastery of a broad range of commercial and clinical topics, including drug pricing dynamics, reimbursement education, value-based care, and the evolving pressures of the hospital and account management environment. + Exceptional capability to serve as a strategic peer to senior leadership, with the influence and communication skills necessary to translate complex technical findings into compelling, actionable narratives. Location + This position is based in South San Francisco, CA and relocation benefits are available _The expected salary range for this position based on the primary location of South San Francisco, CA is $236,900 - $439.900 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below._ Benefits (**************************************************** \#LI-NN2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .

Why Genentech We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society. Who We Are Our Analytics & Insights team is dedicated to solving complex healthcare challenges and improving patient outcomes. The team empowers business partners across Commercial, Medical, and Government Affairs (CMG) to make impactful decisions by leveraging data, analytics, and AI/ML to enable fast, targeted actions in rapidly evolving business contexts. This team fosters a unified understanding of customers, actions, and outcomes by integrating analytics and insights seamlessly into CMG's evolving digital, data, and automation platforms, creating scalable solutions and eliminating silos. You will work as a trusted, objective advisor and expert, recommending critical decisions and actions to be taken with credibility and a focus on driving measurable impact. You will be part of a diverse, inclusive team that reflects the world we serve, thriving in a welcoming culture built on collaboration and innovation. Job Summary At Genentech, our field teams are the vital link to the healthcare ecosystem. We are seeking a visionary Executive Director of Field Analytics & Insights to serve as the chief architect of our field-facing data and insights strategy. Reporting to the VP of Insights & Analytics, you will not just manage a team-you will lead a digital transformation, bridging the gap between data, tools, insights, and frontline field execution. This is a high-impact mandate for a leader who excels at translating complex data and insights into actionable opportunities and who possesses the leadership to advise senior leadership on optimizing field force effectiveness. Executive Leadership & Strategic Advisory * Act as a primary strategic advisor to the senior leadership of Customer Engagement (Sales) and Medical, and Regional Vice Presidents, translating complex business challenges into a cohesive Field insights and analytics roadmap. * Define and evangelize the long-term vision for field force analytics and operational excellence, ensuring alignment across brand, portfolio, and healthcare ecosystem objectives. * Influence cross-functional leadership (HEDs, MEDs, and RVPs) to ensure data-driven decision-making is embedded in the fabric of field operations and long-term business goals. Advanced Analytics & Capability Transformation * Drive the evolution of Genentech's field analytics ecosystem, championing a "tech-forward" approach that integrates advanced data science with field-facing products. * Direct the delivery of high-impact national and sub-national insights, overseeing robust analytics for market trends, product demand forecasting, and sophisticated sales performance modeling. * Optimize field execution strategies through the oversight of key analytics deliverables including: strategic engagement planning tools, territory sizing, targeting, and comprehensive field effectiveness analysis. Operational Excellence & Governance * Architect and govern the Field Incentive Compensation (IC) strategy, ensuring that incentive structures are compliant, motivating, and strictly aligned with organizational milestones. * Modernize field analytics and operations infrastructure by maintaining audit-ready documentation and SOPs while establishing KPIs that measure the efficacy of HCP-facing operations. * Shape the future of field talent by supporting the design of field competency models and performance frameworks, informed by rigorous competitive benchmarking. People & Organizational Development * Lead and mentor a high-performing Insights & Analytics team, fostering an environment that prioritizes both consultative excellence and deep technical mastery. * Cultivate a culture of professional growth, actively developing the next generation of leaders within the analytics and operations space. Minimum Candidate Qualifications & Experience * Bachelor's degree in a quantitative, engineering, or scientific discipline, with an advanced degree preferred. * Minimum of 15 years of progressive leadership within the pharmaceutical or biotech industry, including at least 10 years of dedicated expertise in Field Analytics and Commercial Operations. * Proven track record in architecting and deploying enterprise-grade tools for field execution, including advanced Account Planning, Targeting, Territory Alignment, and Segmentation frameworks. * Extensive experience leading Field Force Effectiveness and the end-to-end design, governance, and execution of complex Incentive Compensation strategies within the US pharmaceutical market. * Expert-level command of US pharma data landscapes, with deep technical proficiency in the application and utility of claims, EMR, specialty pharmacy, and longitudinal patient data. * Established authority in business analytics, commercial operations, and resource management, with a demonstrated ability to translate technical outputs into high-level business strategy. * Exceptional executive presence and communication skills, with a proven ability to advise senior leadership, foster transparent debate, and drive organizational alignment on critical decisions. * Demonstrated ability to lead with operational excellence, managing multiple high-complexity priorities and large-scale projects with a rigorous focus on detail. * Success in leading and mentoring large, high-performing analytics and operations teams, focusing on fostering professional growth and enhancing both technical and consultative skills. Location * This position is based in South San Francisco, CA and relocation benefits are available The expected salary range for this position based on the primary location of South San Francisco, CA is $227,500 - $422,500 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #BoFT #LI-NN2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

** Why Genentech We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society. Who We Are Our Analytics & Insights team is dedicated to solving complex healthcare challenges and improving patient outcomes. The team empowers business partners across Commercial, Medical, and Government Affairs (CMG) to make impactful decisions by leveraging data, analytics, and AI/ML to enable fast, targeted actions in rapidly evolving business contexts. This team fosters a unified understanding of customers, actions, and outcomes by integrating analytics and insights seamlessly into CMG's evolving digital, data, and automation platforms, creating scalable solutions and eliminating silos. You will work as a trusted, objective advisor and expert, recommending critical decisions and actions to be taken with credibility and a focus on driving measurable impact. You will be part of a diverse, inclusive team that reflects the world we serve, thriving in a welcoming culture built on collaboration and innovation. Job Summary At Genentech, our field teams are the vital link to the healthcare ecosystem. We are seeking a visionary Executive Director of Field Analytics & Insights to serve as the chief architect of our field-facing data and insights strategy. Reporting to the VP of Insights & Analytics, you will not just manage a team-you will lead a digital transformation, bridging the gap between data, tools, insights, and frontline field execution. This is a high-impact mandate for a leader who excels at translating complex data and insights into actionable opportunities and who possesses the leadership to advise senior leadership on optimizing field force effectiveness. Executive Leadership & Strategic Advisory + Act as a primary strategic advisor to the senior leadership of Customer Engagement (Sales) and Medical, and Regional Vice Presidents, translating complex business challenges into a cohesive Field insights and analytics roadmap. + Define and evangelize the long-term vision for field force analytics and operational excellence, ensuring alignment across brand, portfolio, and healthcare ecosystem objectives. + Influence cross-functional leadership (HEDs, MEDs, and RVPs) to ensure data-driven decision-making is embedded in the fabric of field operations and long-term business goals. Advanced Analytics & Capability Transformation + Drive the evolution of Genentech's field analytics ecosystem, championing a "tech-forward" approach that integrates advanced data science with field-facing products. + Direct the delivery of high-impact national and sub-national insights, overseeing robust analytics for market trends, product demand forecasting, and sophisticated sales performance modeling. + Optimize field execution strategies through the oversight of key analytics deliverables including: strategic engagement planning tools, territory sizing, targeting, and comprehensive field effectiveness analysis. Operational Excellence & Governance + Architect and govern the Field Incentive Compensation (IC) strategy, ensuring that incentive structures are compliant, motivating, and strictly aligned with organizational milestones. + Modernize field analytics and operations infrastructure by maintaining audit-ready documentation and SOPs while establishing KPIs that measure the efficacy of HCP-facing operations. + Shape the future of field talent by supporting the design of field competency models and performance frameworks, informed by rigorous competitive benchmarking. People & Organizational Development + Lead and mentor a high-performing Insights & Analytics team, fostering an environment that prioritizes both consultative excellence and deep technical mastery. + Cultivate a culture of professional growth, actively developing the next generation of leaders within the analytics and operations space. Minimum Candidate Qualifications & Experience + Bachelor's degree in a quantitative, engineering, or scientific discipline, with an advanced degree preferred. + Minimum of 15 years of progressive leadership within the pharmaceutical or biotech industry, including at least 10 years of dedicated expertise in Field Analytics and Commercial Operations. + Proven track record in architecting and deploying enterprise-grade tools for field execution, including advanced Account Planning, Targeting, Territory Alignment, and Segmentation frameworks. + Extensive experience leading Field Force Effectiveness and the end-to-end design, governance, and execution of complex Incentive Compensation strategies within the US pharmaceutical market. + Expert-level command of US pharma data landscapes, with deep technical proficiency in the application and utility of claims, EMR, specialty pharmacy, and longitudinal patient data. + Established authority in business analytics, commercial operations, and resource management, with a demonstrated ability to translate technical outputs into high-level business strategy. + Exceptional executive presence and communication skills, with a proven ability to advise senior leadership, foster transparent debate, and drive organizational alignment on critical decisions. + Demonstrated ability to lead with operational excellence, managing multiple high-complexity priorities and large-scale projects with a rigorous focus on detail. + Success in leading and mentoring large, high-performing analytics and operations teams, focusing on fostering professional growth and enhancing both technical and consultative skills. Location + This position is based in South San Francisco, CA and relocation benefits are available _The expected salary range for this position based on the primary location of South San Francisco, CA is $227,500 - $422,500 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below._ _Benefits (***************************************************** \#BoFT \#LI-NN2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .