Senior Clinical Trials Manager (Biotech Oncology)

SUMMARY/JOB PURPOSE The Senior Clinical Trials Manager, Clinical Operations (Study Delivery Lead), leads end-to-end design, execution and reporting of clinical trials, ensuring delivery on time, quality, budget and scientific requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES Accountable for global study delivery strategy (country selection, diversity, patient engagement, recruitment plan, etc.) and overall study deliverables. Drive assessment, selection, engagement, management, and oversight of appropriate vendors. Ensure compliance with ICH/GCP guidelines, applicable laws, regulations and company SOPs for all product and service deliverables. Make risk–benefit decisions, mitigating risk where appropriate. Collaborate with matrix partners, Clinical Operations Program Lead or manager to develop and manage study-level budgets within project allocation. Prepare materials for internal governance and financial review cycles. Partner to build relationships and collaborate with aligned staff in other functions. Encourage teams to seek alternative perspectives and develop solutions. Lead investigator meetings and other study-related meetings, and participate in governance meetings as needed. Identify and communicate resource gaps for assigned studies. Lead risk management and quality efforts to ensure study compliance and inspection readiness. 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 data cleaning strategy. Lead the SDT and actively partner to build relationships and collaborate with SDT functional members. Develop patient‑centric documents and address patient burden. Contribute to and engage Clinical Operations staff in process development, innovative problem solving, and training initiatives. Provide proactive and consistent oversight of CRO and vendor performance. Support Clinical Operations Program and/or Indication Lead with key study-level status updates, focused on corporate and project objectives. SUPERVISORY RESPONSIBILITIES None EDUCATION AND EXPERIENCE BA/BS in biological sciences or related field and a minimum of 9years of related experience; or MA/MS in biological sciences or related field and a minimum of 7years of related experience; or PhD/PharmD in biological sciences or related field and a minimum of 2years of related experience; or Equivalent combination of education and experience. QUALIFICATIONS AND SKILLS Typically requires a minimum of 9years of related experience in life sciences, including 7years in clinical research and at least 4years of study management. Experience in starting a study up, work on the maintenance phase, or close‑out of study. Protocol development experience. Proven ability to provide clinical expertise to a clinical development program. Proficiency in clinical studies involving complex design. Experience in independent preparation of clinical sections of IND, BLA, or NDA. Demonstrated ability to write and present clearly using scientific and clinical terminology. Experience in multinational clinical trial management. Experience interacting with outside vendors such as CROs and contract labs. Demonstrated matrix leadership skills. Detailed knowledge of regulations and guidelines. Excellent organizational and planning skills. Strong interpersonal and communication skills (both written and oral). Ability to work effectively in a team/matrix environment. Analytical and business communication skills. JOB COMPLEXITY Capable of anticipating, identifying, prioritizing and resolving task‑related challenges. Excellent interpersonal, organizational, supervisory and project planning skills. DESIRED BEHAVIORS Enterprise mindset, considering broad impact to portfolio, regional and global functions. Curiosity in planning, agile execution. Operational excellence and drive others towards excellence. Resilience in a rapidly changing environment. Organized with systematic approach to prioritization. WORKING CONDITIONS Travel may be required up to 20% in support of clinical study activities. COMPENSATION & BENEFITS Base pay range: $172,000–$245,000 annually, adjusted for geographic region. Total Rewards includes 401(k) with company contributions, group medical, dental, vision, life and disability insurance, flexible spending accounts, discretionary annual bonus, stock purchase option, long-term incentives, 15 accrued vacation days, 17 paid holidays, company‑wide winter shutdown, and up to 10 sick days. DISCLAIMER The preceding job description is designed to indicate the general nature and level of work performed by employees within this classification. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required. EEO STATEMENT We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. #J-18808-Ljbffr Exelixis Inc