Senior Clinical Trials Manager (Biotech Oncology)

Summary The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of clinical trials with leadership in study teams and across matrix teams. This position is accountable for planning and leading the delivery of studies to time, quality, budget, company standards, and scientific requirements as outlined in the clinical study protocol. The Senior Clinical Trials Manager serves as the Study Delivery Lead (SDL) for oncology products from early through late phase, coordinating in‑house, outsourced, and alliance delivery models. Responsibilities Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement, recruitment plan) and overall deliverables. Drive assessment, selection, engagement, management, and oversight of appropriate vendors. Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and Exelixis SOPs for all products and services delivered for the studies. Make decisions that balance risk/benefit with clear understanding of impact on the study and project, and take action to mitigate risk where appropriate. Work with matrix partners and the Clinical Operations Program Lead/manager to develop and manage study‑level budgets within project allocation. Prepare materials for internal governance and/or financial review cycles. Actively partner to build relationships and collaborate with aligned staff in other functions. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions. Lead and conduct investigator meetings and other study‑related meetings, and participate in governance meetings as necessary. Identify and communicate resource gaps for assigned studies. Lead risk management and quality efforts to ensure study compliance and continuous inspection readiness. Lead or contribute to ways of working and process improvement initiatives. Provide expert clinical operational input into protocol development. Partner with Data Management and Clinical Sciences to develop the data‑cleaning strategy for the study. As the SDL, lead the Study Delivery Team (SDT) and actively partner to build relationships and collaborate with SDT functional members. Work with appropriate functions to develop patient‑centric documents and address patient burden. Contribute to and engage Clinical Operations staff in process development, innovative problem solving, and training initiatives as needed. Provide proactive and consistent oversight of CRO and vendor performance. Support the Clinical Operations Program and/or Indication Lead with key study‑level status updates, focusing on delivery to corporate and project objectives. Qualifications BA/BS in biological sciences or related field with a minimum of 9 years of related experience; OR MA/MS with 7 years; OR PhD/PharmD with 2 years; OR equivalent combination of education and experience. Minimum of 9 years of experience in life sciences, including 7 years in clinical research and at least 4 years of study management. Experience starting a study, maintaining a study, or closing out a study. Protocol development experience. Proven ability to provide clinical expertise to a clinical development program. Proficiency in complex‑design clinical studies. Experience with independent preparation of clinical sections of IND, BLA, or NDA. Demonstrated ability to write and present clearly using scientific and clinical terminology. Experience managing multinational clinical trials. Experience interacting with outside vendors (CROs and contract labs). Demonstrated matrix leadership skills. Extensive knowledge of regulations and guidelines, including ICH and GCP. Excellent organizational, planning, interpersonal, and communication skills. Strong analytical and business communication skills. Ability to work effectively in a team/matrix environment. Benefits & Compensation Compensation is based on geographic region and includes a base salary ranging from $172,000 to $245,000 annually, with a Total Rewards program that offers a 401(k) plan, group medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, an annual discretionary bonus program, and the opportunity to purchase company stock. Additional benefits include 15 accrued vacation days in the first year, 17 paid holidays (including a company‑wide winter shutdown in December), and up to 10 sick days. Working Conditions Travel may be required up to 20% in support of clinical study activities. Equal Employment Opportunity We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment on the basis of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability. #J-18808-Ljbffr Exelixis