Senior Clinical Trials Manager (Biotechnology, Oncology)

Role Summary

Senior Clinical Trials Manager, Clinical Operations responsible for end-to-end design, execution, and reporting of oncology clinical trials, leading study teams and matrix colleagues to deliver studies on time, with quality, within budget and to scientific requirements.

Responsibilities

• Accountable for the global study delivery strategy and overall study deliverables.
• Drive assessment, selection, engagement, management, and oversight of vendors.
• Ensure compliance with ICH/GCP guidelines, applicable laws and Exelixis SOPs for designated studies.
• Make decisions balancing risk/benefit with impact on the study; mitigate risks as appropriate.
• Develop and manage study-level budgets within project allocation; prepare governance/financial materials.
• Partner with matrix and functional teams to build relationships and collaboration; encourage diverse perspectives.
• Lead investigator meetings and other study-related meetings; participate in governance as needed.
• Identify and communicate resource gaps; lead risk management and quality efforts for inspection readiness.
• Lead process improvement initiatives and contribute to protocol development with clinical operations input.
• Partner to develop data cleaning strategy; lead the Study Delivery Team (SDT) as SDL and collaborate with SDT members.
• Develop patient-centric documents and address patient burden; participate in process development and problem solving as needed.
• Provide oversight of CRO/vendor performance; support status updates to meet corporate/project objectives.

Qualifications

• Education: BA/BS in biological sciences or related field with 9+ years of related experience; or MA/MS with 7+ years; or PhD/PharmD with 2+ years; or equivalent experience.
• Typically requires at least 9 years of life sciences experience, including 7 years in clinical research and 4 years in study management.

Knowledge / Skills

• Experience starting up, maintaining, or closing out a study; protocol development experience.
• Clinical development program expertise; complex study designs; preparation of clinical sections of IND/BLA/NDA.
• Clear scientific/clinical communication; multinational trial management; vendor interactions (CROs/contract labs).
• Matrix leadership, regulatory knowledge, organizational and planning skills, strong written and oral communication.
• Ability to work effectively in a matrix team; strong analytical and business communication skills.

Education

• As listed in Qualifications above.

Additional Requirements

• Travel up to 20% may be required in support of clinical study activities.