Medical Director jobs at Genentech - 51 jobs

** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. **The Opportunity** We are seeking a dynamic medical leader with a background in Neuroimmunology to join the Medical network at Genentech. This position will report to the Therapeutic Area Lead (TAL) for Neuroimmunology within the Neurology Therapeutic Area. The Principal Medical (Science) Director will provide exceptional clinical and scientific leadership for medical affairs activities in the area of Neuroimmunology and related disorders, aiming to generate and communicate medical evidence that aids practitioners, patients, and payers in making informed health care decisions. The successful candidate will exhibit outstanding communication and leadership skills, building strong relationships with key stakeholders. This role also requires representing the US Medical function within cross-functional teams and initiatives at Genentech, Roche's global organization, and external customer engagements, with an emphasis on leading fit-for-purpose teams, prioritizing work flexibly, and engaging in partnerships to address complex multidisciplinary challenges. Key Responsibilities + Provide the medical perspective to a broader network of Medical Affairs professionals in both home and field organizations. + Contribute to defining science and medical strategies that lead to impactful medical affairs tactics, particularly in the early stages of asset and indication development. + Design, execute, and monitor medical strategies, plans, and tactics throughout the product lifecycle. + Represent Genentech Medical Affairs externally at key meetings. + Develop scientific partnerships with therapeutic area experts and execute collaborations. + Lead efficient implementation of medical tactics by leveraging relevant expertise and insights. + Execute US Medical/global clinical trial activities conducted as part of Medical Affairs. **Who you are** **Qualifications & Experience** + Advanced Clinical/Science Degree required (e.g. PharmD, PhD, MD etc.) + Minimum 5-10+ years of relevant clinical / medical pharmaceutical/biotechnology industry experience with deep knowledge of Inflammatory Bowel Disease + Experience or relevant knowledge of pre-approval drug development trials and/or post marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations + Understanding of the US health care environment including the payer landscape, evidence based medicine tools and practices, and health technology assessments + Ability to navigate complex and challenging situations and flex and thrive in an ambiguous environment. **Location and** **Travel Requirements** The position is located in South San Francisco an may require up to an additional 35% time traveling. The expected salary range for this position based on the primary location of South San Francisco, CA is $224,800 - $515,800. 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 (**************************************************** Relocation benefits are not available for this job posting. 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 (***************************************************************************************************** .

A leading biopharmaceutical company is seeking a Senior Director for Medical Affairs to lead initiatives focused on liver diseases. The ideal candidate should have substantial clinical experience in hepatology and a commitment to scientific excellence. This remote position requires strategic collaboration and contributions to research efforts to improve liver care outcomes. Strong leadership and communication skills are essential for engaging diverse healthcare professionals in clinical discussions. #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. Key Responsibilities Strategic Evidence Planning Serve as a senior member of the Evidence Generation (EG) leadership team, co‑driving the evolution of Kite's US evidence generation strategy and value proposition. Support the development and execution of the Integrated Evidence Plan (IEP) in collaboration with the Evidence Generation Function, Global Medical Affairs Strategy, and Product Teams. Identify critical evidence gaps and define the most appropriate research approaches (retrospective, prospective, interventional, RWE) to address unmet needs. Study Oversight and Execution Provide scientific and medical oversight for all Medical Affairs / Kite‑Sponsored Studies, including interventional trials, non‑interventional studies, and US Strategic Alliances. Lead the development of clinical study concepts and protocols in collaboration with Medical and Clinical Development teams. Oversee the US Investigator‑Sponsored Research (ISR) and Collaborative Research (CR) program, ensuring scientific merit, alignment with strategic priorities, and compliance. Serve as the Medical Monitor for assigned evidence generation studies, ensuring timely execution, data quality, and compliance with GCP and internal SOPs. Provide strategic oversight and clinical guidance to operational teams for timely and impactful execution. Data Interpretation and Dissemination Lead the medical review, interpretation, and communication of study results, including drafting publications, abstracts, posters, and internal/external presentations. Serve as a medical expert for study data, engaging with internal and external stakeholders and Key Opinion Leaders (KOLs). Collaborate with Global Medical Strategy to ensure accurate and compliant dissemination of generated evidence. Cross‑Functional Collaboration and Compliance Partner across Kite Medical Affairs, Clinical Development, Translational Medicine, Regulatory Affairs, and Product Teams to build integrated cross‑functional capabilities. Mentor and provide guidance on evidence generation best practices, methodologies, and compliance requirements. Ensure all evidence generation activities comply with Kite/Gilead policies, local regulations, and the highest ethical standards. Design and implement strategies to accelerate evidence generation through external platforms, technologies, and data‑driven insights. Represent the Evidence Generation function at core Kite governance bodies (e.g., Product Teams, Global Medical Teams, JSC). Scientific Engagement Champion medical innovation by integrating emerging scientific trends and technologies into US evidence generation strategies. Lead external engagement efforts to enhance scientific credibility and foster meaningful partnerships with healthcare professionals and institutions. Serve as a member of the central External Research Program screening/review committee and manage joint steering committees for strategic collaborations. Qualifications Required MD or equivalent medical degree. Minimum 5 years of experience in the biopharmaceutical industry, with at least 5 years in medical affairs, clinical development, or evidence generation. Proven leadership in designing and managing clinical trials, including Phase IV and investigator‑sponsored studies. Understanding of the cell‑therapy landscape, including regulatory and post‑approval evidence needs. Preferred Experience in CAR‑T or related advanced modalities (gene therapy, immuno‑oncology). Demonstrated success in leading teams and cross‑functional partnerships. Strong strategic thinking, project management, and stakeholder engagement skills. Familiarity with digital platforms and real‑world data methodologies. Other Requirements Willingness to travel domestically up to 20-30%. Strong communication and stakeholder management skills. The salary range for this position is: Other US Locations: $255,425.00 - $330,550.00. Bay Area: $281,010.00 - $363,660.00. 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, paid time off, and a benefits package, including company‑sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: Gilead Compensation & Benefits. For jobs in the United States 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 will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status, or any other protected characteristic. For accommodations, please contact ApplicantAccommodations@gilead.com. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. Notice: EMPLOYEE POLYGRAPH PROTECTION ACT, YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinions. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking a Director, Medical Insights to lead the strategy and execution for Inflammation, Viral Hepatitis, and COVID. This role requires strong leadership, analytical skills, and significant pharma experience. The successful candidate will establish core insights capabilities and drive transformation projects across Medical Affairs. A minimum of a Bachelor's degree and extensive experience in the pharmaceutical sector are essential. #J-18808-Ljbffr

We have an exciting opportunity within the US Medical Affairs (USMA) organization for an Associate Director within Oncology Medical Strategy. Reporting to Executive Director of USMA Oncology Strategy, this role will be responsible for providing Medical support to the development and execution of the USMA strategic and tactical plans in collaboration with the broader US and Global Medical Affairs teams. Provide clinical and scientific input on Independent Medical Education, Grants and / or Investigator-Sponsored Research / Collaborative Research, and Medical Information response documents for oncology products / pipeline molecules, as needed Demonstrates strong project management / execution skills to ensure the successful delivery of the Local Strategic Plan (strategy plan) and Medical Plan of Action (tactical plan), amongst other projects as assigned Basic QualificationsBachelor's Degree and Ten Years' ExperienceMaster's Degree and Eight Years' ExperienceOR* MD and Two Years' ExperiencePhD, PharmD and Five Years' Experience Preferred Qualifications PhD, PharmD, or MD strongly preferred with pharmaceutical, clinical, or research experience in oncology therapeutic area Prior US, Global, or large affiliate experience in Oncology Medical Affairs Industry experience with knowledge of all applicable regulatory and legal requirements for Medical Affairs activities Excellent written, verbal, presentation, interpersonal, relationship-building, and negotiating communication competencies Superior analytical skills to identify complex challenges and interpret key findings from study data and publications Strong organizational skills, attention to detail, and ability to meet timelines in a fast-paced environment with a high level of autonomy and independence Experience working in a highly matrixed organization with a proven ability to build internal relationships, manage stakeholders, prioritize work appropriately, and manage workload while delivering results Ability to shape positive dialogues, influence outcomes, and respectfully challenge a group of experts 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.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: #J-18808-Ljbffr

A leading biotechnology company in California is seeking a Senior Director for Medical Affairs focusing on HIV Treatment. The ideal candidate will provide strategic medical leadership, support commercial activities, and ensure alignment across teams. A medical background with significant experience in the pharma industry is required. This full-time role involves collaboration and leadership to address major health challenges and improve patient outcomes. #J-18808-Ljbffr

Location: United States - New Jersey (Parsippany), United States - California (Foster City) - Medical Affairs (Regular) Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. We strive to transform and simplify care for people with life‑threatening illnesses around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, COVID, HBV, HCV, HDV, Oncology and Cell Therapy as well as Inflammatory Diseases. Gilead is a patient‑centric, science‑focused company. Reporting to the Executive Director, Insights, Digital and Analytics in GMSO (Global Medical Strategy and Operations), this individual will be the medical insights leader responsible for the integrated insights capability in addition to the strategy, process and tactical execution for Inflammation, Viral Hepatitis & COVID TA. The Director will establish medical insights core capabilities, define best practices, develop an insights research agenda and strategy, partner with cross‑functional teams to drive the integration of insights into plans of action, and lead transformation and innovation projects to advance insights contributions across Medical Affairs. Responsibilities Spearhead the connection and alignment between medical insights, medical impact, and actionability towards strategy. Curate and execute complex, cross‑functional medical affairs data analyses; translate data into actionable insights focused on implications for the assigned therapeutic area. Be viewed as a Medical Insights thought leader by TA stakeholders and sought out as a trusted strategic advisor. Use systematic processes to gather, summarize, communicate, and track global and cross‑functional medical insights relevant to the business needs of a given therapeutic area. Deliver insights to Medical Affairs TA leaders and functions to support strategic planning and more effective tactical deployment. Liaise and partner with cross‑functional groups including Development, Commercial, Competitive Intelligence and other insights‑focused organisations to identify key medical insights impacting strategic decisions and tactical execution. Lead and collaborate with cross‑medical teams and forums to deliver insights focused on actionability and local responsiveness of relevant tactics. Develop medical insights POA and deliver insights for cross‑functional partners to integrate into functional POAs; drive insights strategy and deliver tactics. Foster ways of working within and across functions and teams to share knowledge and insights that help advance patient care and deliver on business goals. Support communication and roll‑out of insights best practices, training, processes and ways of working. Lead and collaborate on medical insights transformation and innovation projects to deliver on business goals and increase the value of Medical Insights to Gilead. Drive continuous improvement to optimise insight generation processes, including algorithmic tuning, best practice sharing, training support, benchmarking, and process assessment. Lead the development of written Standard Operating Procedures and documentation of newly established processes. Lead work with vendors and act as a primary point of contact for the strategy and execution of Medical Insights projects and operations. Effectively manage the annual budget related to Medical Insights activities. Knowledge, Experience and Skills Bachelor's degree and 12 years' experience OR master's degree and 10 years' experience OR PhD and 8 years' experience. Scientific degree with significant business experience and/or business degree with significant scientific experience. 5‑7 years global/in‑market Pharma/Biopharma experience. Preferable experience in Inflammation and Viral Hepatitis. Scientific and/or clinical understanding and solid understanding of medical affairs principles to identify priority and relevance of various clinical data and stakeholder input. Thorough understanding of medical affairs' purpose, ways of working, and tactical execution. Strong curiosity, desire to continuously learn, comfort with ambiguity, and ability to adapt to change. Ability to research, analyse, curate and deliver medical insights, drawing upon experience and expertise to meet customer unmet needs and business goals. Deep knowledge of the pharmaceutical sector and trends, drug development and commercialization, launch, product lifecycle, healthcare landscape, and scope and impact of medical affairs functions. Leadership skills with the ability to mentor others and lead project teams. Sound business judgment and effective influencing skills to help teams and leadership achieve business goals. Excellent verbal, written and interpersonal skills to effectively communicate with colleagues and cross‑functional leadership. Display of Gilead Core Values Integrity (Doing What's Right) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Inclusion (Encouraging Diversity) Job Requisition ID: R0043917 Job Level: Director #J-18808-Ljbffr

United States - California - Foster City Medical Affairs Regular Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life‑threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia, and Australia. For more information please visit Gilead.com. We have an exciting opportunity within our Global Medical Affairs team for a Manager, Global Medical Affairs within Oncology, Breast Cancer, located in Foster City, CA. Specific Job Requirements Collaborates with project management, R&D, medical communications, and commercial teams in multiple areas including publication planning, evidence generation plan, data gap analysis, speaker education programs, reviews of manuscripts/abstracts/conference presentations, conference preparation, advisory boards, and investigator meetings. Regular communication with the Gilead Medical Scientist (MS) team to remain abreast of issues in the field and to provide medical education, support, and direction to them. Collaborates with medical and scientific input on Independent Medical Education, Grants, Investigator‑Sponsored Research, Collaborative Research, and Promotional Review Committee. Working with the Assoc Director, Directors, Executive Director, and Vice President on early development of a variety of projects, provides independent thought and initiative in the further development of specific projects and ensuing presentations and reports. Manages projects to completion, anticipating obstacles and difficulties that may arise, and collaboratively resolving them. May attend major conferences and help coordinate medical affairs activities at conferences and may present to external audiences. Collaborates with the development and execution of projects that will provide more extensive background, and additional data/answers to questions in response to issues relative to commercial, scientific, or data needs. Collaborates with the Medical Affairs Lead on select scientific issues/topics using expertise to support the development of global scientific messages, inform strategy, create/update slide decks, and review Medical Information response documents. Collaborates with the Assoc Director, Directors, and Executive Director to develop a global Plan of Action and ensure alignment of team activities. Specific Knowledge, Education, and Experience Requirements The ideal candidate will be a DO, Ph.D., or PharmD with zero years of experience, OR an MA/MS with 4 years of experience OR a BA/BS and 6 years of clinical and/or research experience in hematology and/or oncology therapeutic area. Prior Global or large affiliate experience in medical affairs activities preferred. Industry experience with knowledge of all applicable regulatory and legal requirements for Medical Affairs activities is preferred. Excellent written, verbal, presentation, interpersonal, relationship‑building, and negotiating communication skills. Excellent analytical skills demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications. Organized; attention to detail and able to meet timelines in a fast‑paced environment. Experience in developing effective abstracts, manuscripts, posters, and slides and presenting at scientific meetings. Ability to work on multiple projects simultaneously and effectively prioritize workload. Ability to suggest solutions for issues encountered with clinical studies and other projects in area of responsibility. Must be able to work with a level of autonomy and independence. Prior supervisory/leadership experience preferred. Ability to travel to domestic and international conferences which will include occasional weekend travel is required. (25% expected) Display of Gilead Core Values Integrity (Doing What's Right) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Inclusion (Encouraging Diversity) Job Requisition ID: R0045213 Job Level: Manager Job Type: Full Time/Part Time Full-Time #J-18808-Ljbffr

United States - California - Foster City | Medical Affairs Regular We are seeking a Manager within Phase 4 Research to support HIV Treatment within Global Medical Affairs. This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative research, and MA-led Gilead-sponsored research in HIV Treatment. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of one or more of relevant therapeutic areas. This position is based at Gilead's Foster City, CA location. Specific Job Responsibilities Manage the review of ISR, CO and MA-led GS proposals through Gilead's Research Committee (RC) review process for HIV Treatment. Coordinate proposal review meetings with RC Team Leads and RC Chairs. Support creation and management of requests for proposals (RFPs). Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Gilead. Support the management of the HIV Treatment Phase 4 portfolio including liaising with key cross-functional partners such as Clinical Operations, local affiliates and external investigators. May review abstracts and/or manuscripts that result from the phase 4 program. Contribute to ensuring that the research processes and study execution align with MA research policy and governance, integrated evidence plan priorities, and overall program strategy. Work with Senior Manager to track, monitor and intervene with external investigators to ensure timely execution of contracted studies, and support closure of studies when not meeting contracted milestones. Act as a resource for Research Committee Chairs, voting members, standing members, proposal champions and reviewers. Contribute to process improvements related to research proposal and study management systems. Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner and engage in project management activities as needed by assigned RC Team Lead and/or Senior Manager. Basic Qualifications High School Degree and Eleven Years' Experience Associates Degree and Nine Years Experience Bachelor's Degree and Seven Years' Experience Masters' Degree and Five Years' Experience Preferred Qualifications Professional degree (eg, PhD, PharmD); OR master's degree (eg, MS, MPH) with 4-plus years of experience in clinical or observational research including research operations; OR Bachelor's degree with 6-plus years of experience. Must be cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials. Demonstrated project management and organization skills including process improvement, management of multiple resources and priority projects with tight timelines while maintaining attention to detail. Ability to work in a global environment which may require participation in meetings outside of standard work hours to accommodate time zone differences. Affinity for a collaborative, team-oriented environment, and approach; must be able to appropriately interact within MA and across Development, senior management, and external customers/vendors. Excellent interpersonal, written, and verbal communication skills. Proven track record of executing clearly defined goals and objectives in a fast-paced environment. Self‑motivated to work independently and having a positive attitude while working as part of teams. Ability to engage and manage multiple stakeholders to achieve the objective. Understanding/experience in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development. Scientific knowledge/experience one or more of the relevant therapeutic areas. 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 global biopharmaceutical company is seeking a Director of Digital Health Solutions in Foster City, CA. This role involves transforming patient experiences through digital solutions, requiring strategic leadership and cross-functional collaboration. The ideal candidate will have significant experience in pharma, a Master's degree or higher, and a track record in customer experience and digital health technologies. Competitive compensation and a comprehensive benefits package are offered. #J-18808-Ljbffr

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. BioMarin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring BioMarin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring. Summary Description: Fully remote role - US based candidates The Medical Director has a key scientific and analytical leadership role in the development of CLS core deliverables across study planning, design and execution, results analysis and regulatory filings. Key focus areas include: acting as a study Medical Monitor and providing the scientific input into the creation and review of all CLS study deliverables and monitoring subject eligibility, study data and contributing critically to the scientific interpretation and integration of clinical study results.The Medical Director will also contribute to the scientific strategy and plan as outlined in the Clinical Development Plan (CDP). The Medical Director is also responsible for providing medical input into the creation and review of all CLS study deliverables to support clinical decision making, problem solving, and safety surveillance, as well as collaboration with external physician stakeholders. Key Responsibilities: Scientific Leadership Support the definition of the core clinical and scientific strategy that serves as the basis for the CDP and provide CLS expertise in the design and execution of clinical studies under the purview of the CDP Participate (as assigned) in the development of CLS-assigned sections of regulatory filings and in drafting regulatory responses in collaboration with Medical Writing Establish relationships with investigators and KOLs as appropriate in support of the CDP Stay up to date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication Attend and contribute to relevant scientific conferences, seminars or presentations Clinical Study Planning and Monitoring Act as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk Initiate and provide the medical and scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions and other key study deliverables Provide clinical input to statistical analysis plan to ensure alignment with Regulatory and business interests Facilitate the review and approval of all study related CLS deliverables and content Act as study scientific subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues Provide leadership to sites by developing or participating in training, answering investigator/site questions about the protocol Respond to site and Health Authority questions about the protocol Conduct periodic review of protocol deviations in collaboration with Clinical Operations Study Lead or designee (per protocol specific Protocol Deviation Plan) Attend and present at Investigator Meetings, as needed Conduct data review, assessment and interpretation of clinical data to ensure that the data are correct and presented with the appropriate interpretation including thorough review of SAEs and other important AEs (per the study specific Medical Monitoring Plan) Review and analyze SAEs, safety and efficacy trends on an ongoing basis Work closely with the Pharmacovigilance representatives providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports and preparation of labels Participate in and provide scientific advice, as appropriate, during key Database Lock (DBL) activities (final listing review, review of blinded tables, listings and figures (TLFs), etc.) and actively participate in all data snapshots taken (not limited to final DBL) Collaborate with Biometrics to identify key issues, prepare content and facilitate discussions at study Data Review Board (internal) or Data Monitoring Committee (DMC) Lead the selection of and interactions with independent Data Monitoring Committees (DMC) The Medical Director will also act as the medical subject matter expert for review of clinical and safety data to ensure data are correct and presented with the appropriate medical interpretation and for discussing safety concerns with sites Governance and Communication Provide timely and high-quality functional deliverables and contributions to Study Execution Team (SET) Act as primary point of contact between SET and BCLS to ensure appropriate dissemination of information and communication (including functional managers and other relevant individuals) Provide agenda topics to be discussed during SET meetings Act as the medical and scientific subject matter expert (SME) to the SET with the ability to make decisions and recommendations on behalf of BCLS Proactively identify and communicate potential risks and mitigations relevant to the BCLS deliverables Contribute to the development and maintenance of study- specific plans; manage the development of study-specific plans that are the responsibility of BCLS Collaborate with BCLS Therapeutic Area Lead, CDTL and CSL on all study related decisions, as appropriate Escalate issues affecting BCLS function deliverable quality, timelines, resources or budget, as appropriate Competencies The Medical Director is expected to exhibit mastery-level understanding of multiple technical competencies, including scientific knowledge, data analysis, and scientific writing. S/he should also have advanced-level competence in several areas, including strategic thinking and problem solving. The Medical Director should: Identify scientific and medical knowledge gaps in therapeutic area and target populations to drive research and publication strategies Assess the clinical and medical impact of clinical and external research findings and data on overall therapeutic area and clinical development strategies Conduct comprehensive document evaluations including evaluation of statistical presentations, research methods, quality and completeness of content Identify internal and external best practices, trends, developments or alternative approaches that can be leveraged for strategy development Demonstrate ability to look beyond the obvious toward innovative approaches, avoiding biases and historical crutches The Medical Director will also demonstrate mastery of relevant clinical and therapeutic area knowledge to support clinical decision making, problem solving, safety surveillance, and as well as collaboration with external physician stakeholders. Education and Experience: MD, MD/PhD (or equivalent) Advanced degree in life or health sciences (e.g. PhD/PharmD/RN) 5 or more years of relevant experience in Clinical Development, with experience in genetic diseases, specialty care, and/or rare diseases desired; Clinical experience preferred Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. The Opportunity We are seeking a dynamic medical leader with a background in Neuroimmunology to join the Medical network at Genentech. This position will report to the Therapeutic Area Lead (TAL) for Neuroimmunology within the Neurology Therapeutic Area. The Principal Medical (Science) Director will provide exceptional clinical and scientific leadership for medical affairs activities in the area of Neuroimmunology and related disorders, aiming to generate and communicate medical evidence that aids practitioners, patients, and payers in making informed health care decisions. The successful candidate will exhibit outstanding communication and leadership skills, building strong relationships with key stakeholders. This role also requires representing the US Medical function within cross-functional teams and initiatives at Genentech, Roche's global organization, and external customer engagements, with an emphasis on leading fit-for-purpose teams, prioritizing work flexibly, and engaging in partnerships to address complex multidisciplinary challenges. Key Responsibilities * Provide the medical perspective to a broader network of Medical Affairs professionals in both home and field organizations. * Contribute to defining science and medical strategies that lead to impactful medical affairs tactics, particularly in the early stages of asset and indication development. * Design, execute, and monitor medical strategies, plans, and tactics throughout the product lifecycle. * Represent Genentech Medical Affairs externally at key meetings. * Develop scientific partnerships with therapeutic area experts and execute collaborations. * Lead efficient implementation of medical tactics by leveraging relevant expertise and insights. * Execute US Medical/global clinical trial activities conducted as part of Medical Affairs. Who you are Qualifications & Experience * Advanced Clinical/Science Degree required (e.g. PharmD, PhD, MD etc.) * Minimum 5-10+ years of relevant clinical / medical pharmaceutical/biotechnology industry experience with deep knowledge of Inflammatory Bowel Disease * Experience or relevant knowledge of pre-approval drug development trials and/or post marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations * Understanding of the US health care environment including the payer landscape, evidence based medicine tools and practices, and health technology assessments * Ability to navigate complex and challenging situations and flex and thrive in an ambiguous environment. Location and Travel Requirements The position is located in South San Francisco an may require up to an additional 35% time traveling. The expected salary range for this position based on the primary location of South San Francisco, CA is $224,800 - $515,800. 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 Relocation benefits are not available for this job posting. 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.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. The Opportunity We are seeking a dynamic medical leader to join the US Medical Affairs network of scientists at Genentech with the neurological rare diseases (NRD) team. This position will provide exceptional clinical and scientific leadership for medical affairs activities in NRD, aiming to generate and communicate medical evidence that aids practitioners, patients, and payers in making informed health care decisions. The successful candidate will exhibit outstanding communication and leadership skills, building strong relationships with key stakeholders. This role also requires representing the US Medical function within cross-functional teams and initiatives at Genentech, Roche's global organization, and external customer engagements, with an emphasis on leading fit-for-purpose teams, prioritizing work flexibly, and engaging in partnerships to address complex multidisciplinary challenges. Key Responsibilities Provide the medical perspective to a broader network of Medical Affairs professionals in both home and field organizations. Contribute to defining science and medical strategies that lead to impactful medical affairs tactics. Design, execute, and monitor medical strategies, plans, and tactics throughout the product lifecycle. Represent Genentech Medical Affairs externally at key meetings. Develop scientific partnerships with therapeutic area experts and execute collaborations. Lead efficient implementation of medical tactics by leveraging relevant expertise and insights. Execute USMA/global clinical trial activities conducted as part of Medical Affairs. Who you are Required Qualifications & Experience Advanced Clinical/Science Degree required (e.g. PharmD, PhD, MD etc.) Minimum 5-10+ years of relevant clinical/medical pharmaceutical/biotechnology industry experience preferably in the neurology area. Experience or relevant knowledge of pre-approval drug development trials and/or post marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations Understanding of the US health care environment including the payer landscape, evidence based medicine tools and practices, and health technology assessments Ability to navigate complex and challenging situations and flex and thrive in an ambiguous environment. Travel Requirements The position is located in South San Francisco. The position may require up to an additional 35% time traveling. The expected salary range for this position based on the primary location of South San Francisco, CA is $224,800 - $515,800. 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. 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.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. US Medical, part of Genentech, is passionate about delivering on Our Promise to improve the lives of patients. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex health challenges. To achieve this, Genentech has identified establishing world-class digital medical capabilities as a key priority. The Opportunity We are seeking a results-driven Medical Omnichannel Strategic Excellence Leader to drive a transformative shift in how US Medical engages customers. This leadership role will develop and implement cutting-edge omnichannel capabilities and cultivate a culture of digital excellence. As a strong matrix leader, you will drive behavioral change across US Medical (600+ employees) while compliantly collaborating closely across our Roche functions/partners. As a key leader on the Medical Business Activation cross-functional capability team, you set omnichannel capability priorities, ensuring the solutions built meet the needs of US Medical. Key Responsibilities Increase Medical Customer Engagement with Omnichannel: Significantly enhance the quality, relevance, and impact of our medical interactions with healthcare professionals (HCPs), patients, and other key stakeholders across all touchpoints through the creation and adoption of digital medical capabilities. Shape Future Medical Capabilities & Experience: Proactively identify future capability needs based on evolving medical priorities, setting a strategic activation roadmap to deliver an omnichannel customer experience that maximizes medical impact. Senior Matrix Leadership & Influence: Drive the cultural and operational transformation across Medical, ensuring widespread adoption and successful implementation of our omnichannel and digital strategies. You'll serve as the US Medical Omnichannel lead in all high-level, cross-functional priority-setting discussions. People Leader: manage a direct report and functional service provider team of embedded Medical leads responsible for implementing cross-portfolio & therapeutic area omnichannel programs/tactics and evolving digital capabilities. Who you are Qualifications & Experience * 12+ years of relevant healthcare communications, omnichannel strategy/execution, and healthcare experience. Advanced Degree Required (Masters' or higher: MS, MBA, PharmD, PhD or MD) * Experience in the Pharmaceutical / Biotech industry, leading large cross-functional teams to achieve strategic objectives and leading across multiple therapeutic areas. Medical Affairs or similar type experience in healthcare functions preferred * Omnichannel Expert: Breadth of experience in omnichannel strategies, and advanced ability to define and measure successful medical engagement impact through digital approaches and innovative metrics. * Healthcare Ecosystem Expert: Advanced knowledge of the US healthcare ecosystem, regulatory environment, and digital trends. * Market & Insights Mastery: Advanced ability to synthesize customer, TA, and market insights to drive strategic medical engagement planning. * Cross-Functional Leadership: Proven ability to lead without authority and integrate cross-functional teams to deliver exceptional Customer Experience and build new Medical Capabilities. Location & Travel Requirements This position is based in South San Francisco, CA, and offers a hybrid schedule working in the office 3 days per week. Occasional business travel may be required. The expected salary range for this position based on the primary location of South San Francisco, CA is $214,500 - 398,300. 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 Relocation benefits are not available for this job posting 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.

** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. US Medical, part of Genentech, is passionate about delivering on Our Promise to improve the lives of patients. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex health challenges. To achieve this, Genentech has identified establishing world-class digital medical capabilities as a key priority. **The Opportunity** We are seeking a results-driven Medical Omnichannel Strategic Excellence Leader to drive a transformative shift in how US Medical engages customers. This leadership role will develop and implement cutting-edge omnichannel capabilities and cultivate a culture of digital excellence. As a strong matrix leader, you will drive behavioral change across US Medical (600+ employees) while compliantly collaborating closely across our Roche functions/partners. As a key leader on the Medical Business Activation cross-functional capability team, you set omnichannel capability priorities, ensuring the solutions built meet the needs of US Medical. **Key Responsibilities** Increase Medical Customer Engagement with Omnichannel: Significantly enhance the quality, relevance, and impact of our medical interactions with healthcare professionals (HCPs), patients, and other key stakeholders across all touchpoints through the creation and adoption of digital medical capabilities. Shape Future Medical Capabilities & Experience: Proactively identify future capability needs based on evolving medical priorities, setting a strategic activation roadmap to deliver an omnichannel customer experience that maximizes medical impact. Senior Matrix Leadership & Influence: Drive the cultural and operational transformation across Medical, ensuring widespread adoption and successful implementation of our omnichannel and digital strategies. You'll serve as the US Medical Omnichannel lead in all high-level, cross-functional priority-setting discussions. People Leader: manage a direct report and functional service provider team of embedded Medical leads responsible for implementing cross-portfolio & therapeutic area omnichannel programs/tactics and evolving digital capabilities. **Who you are** **Qualifications & Experience** + 12+ years of relevant healthcare communications, omnichannel strategy/execution, and healthcare experience. Advanced Degree Required (Masters' or higher: MS, MBA, PharmD, PhD or MD) + Experience in the Pharmaceutical / Biotech industry, leading large cross-functional teams to achieve strategic objectives and leading across multiple therapeutic areas.Medical Affairs or similar type experience in healthcare functions preferred + Omnichannel Expert: Breadth of experience in omnichannel strategies, and advanced ability to define and measure successful medical engagement impact through digital approaches and innovative metrics. + Healthcare Ecosystem Expert: Advanced knowledge of the US healthcare ecosystem, regulatory environment, and digital trends. + Market & Insights Mastery: Advanced ability to synthesize customer, TA, and market insights to drive strategic medical engagement planning. + Cross-Functional Leadership: Proven ability to lead without authority and integrate cross-functional teams to deliver exceptional Customer Experience and build new Medical Capabilities. **Location & Travel Requirements** This position is based in South San Francisco, CA, and offers a hybrid schedule working in the office 3 days per week. Occasional business travel may be required. The expected salary range for this position based on the primary location of South San Francisco, CA is $214,500 - 398,300. 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 (**************************************************** Relocation benefits are not available for this job posting 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 (***************************************************************************************************** .

Career CategoryClinical DevelopmentJob Description JOIN AMGEN'S MISSION OF SERVING PATIENTS At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Executive Medical Director, Obesity Live What you will do Let's do this. Let's change the world. The Obesity organization is seeking an Executive Medical Director that will oversee a team of physician-scientists that support evidence generation for obesity and obesity-related conditions, as well as supporting and reporting into the Vice President, Obesity. Responsibilities Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for multiple metabolic assets. Support (and lead when requested) cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program Participate and provide clinical input into safety and regulatory interactions Interpret and communicate clinical trial data Oversee the authoring of clinical study reports, publications and regulatory submissions Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated the Vice President. Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization Contribute to TPP (target product profile) and Global Product Safety (GPS) development Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG), and Portfolio Governance. Interact with TA leadership and extended team to develop strategics options Interact and collaborate with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options. Provide clinical and scientific input to business development interactions including due diligence processes. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Five years of industry or academic research AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resource Preferred Qualifications: Five (5) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) in obesity or obesity-related conditions. Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Previous experience in regulatory interactions. Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements Leadership experience/potential as a medical expert in a complex matrix environment Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The annual base salary range for this opportunity in the U.S. is $343,334 - $403,728. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. . Salary Range 343,334.00 USD - 403,728.00 USD

**JOIN AMGEN'S MISSION OF SERVING PATIENTS** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Executive Medical Director, Obesity** **Live** **What you will do** Let's do this. Let's change the world. The Obesity organization is seeking an Executive Medical Director that will oversee a team of physician-scientists that support evidence generation for obesity and obesity-related conditions, as well as supporting and reporting into the Vice President, Obesity. **Responsibilities** + Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for multiple metabolic assets. + Support (and lead when requested) cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program + Participate and provide clinical input into safety and regulatory interactions + Interpret and communicate clinical trial data + Oversee the authoring of clinical study reports, publications and regulatory submissions + Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated the Vice President. + Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization + Contribute to TPP (target product profile) and Global Product Safety (GPS) development + Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG), and Portfolio Governance. + Interact with TA leadership and extended team to develop strategics options + Interact and collaborate with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options. + Provide clinical and scientific input to business development interactions including due diligence processes. **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications. **Basic Qualifications:** + MD or DO degree from an accredited medical school AND + Five years of industry or academic research AND + 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resource **Preferred Qualifications:** + Five (5) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) in obesity or obesity-related conditions. + Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities + Previous experience in regulatory interactions. + Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty + Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes + Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes + Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements + Leadership experience/potential as a medical expert in a complex matrix environment + Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication + Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path They will also embody the Amgen leadership attributes which are: + **Inspire:** Create a connected, inclusive, and inspiring work environment that empowers talent to thrive + **Accelerate:** Enable speed that matches the urgency of patient needs by encouraging progress over perfection + **Integrate:** Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders + **Adapt:** Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results **Thrive** **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The annual base salary range for this opportunity in the U.S. is $343,334 - $403,728. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans and bi-annual company-wide shutdowns + Flexible work models, including remote work arrangements, where possible As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Career CategorySafetyJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Medical Director - Hematology/Oncology What you will do Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed. Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Experience in the study/research and/or treatment of Oncology disease states What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 243,245.00 USD - 319,267.00 USD

Career CategorySafetyJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Medical Director - Hematology/Oncology What you will do Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed. Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Experience in the study/research and/or treatment of Oncology disease states What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 243,245.00 USD - 319,267.00 USD