Senior Clinical Trials Manager (Biotechnology Oncology)
Exelixis
20 days ago
On-site
Alameda, CA
Clinical Research and Development
Summary/Job Purpose
- The Senior Clinical Trials Manager, Clinical Operations, serves as Study Delivery Lead (SDL), accountable for end-to-end planning, execution, and reporting of clinical trials through time, quality, budget, company standards, and protocol requirements.
Essential Duties and Responsibilities
- Own global study delivery strategy and overall study deliverables (e.g., country selection, diversity, patient engagement, recruitment).
- Assess, select, engage, manage, and oversee appropriate vendors (including CROs/contract labs).
- Ensure compliance with ICH/GCP, applicable laws/regulations, and company SOPs.
- Balance risk/benefit decisions; mitigate risks as needed.
- Develop/manage study-level budget within project allocation; prepare materials for governance/financial reviews.
- Lead investigator and other study meetings; participate in governance meetings.
- Identify and communicate resource gaps; lead risk management and quality/inspection readiness.
- Lead/contribute to ways of working and process improvement; provide clinical operational input into protocol development.
- Partner with Data Management and Clinical Sciences on data cleaning strategy.
- As SDL, lead the Study Delivery Team (SDT) and partner across functions to support patient-centric documents and reduce patient burden.
- Provide proactive oversight of vendor performance and deliver study status updates.
Education/Experience (Required)
- BA/BS + 9+ years relevant experience; or MA/MS + 7+; or PhD/PharmD + 2+; or equivalent.
Experience (Preferred/Ideal)
- Minimum 9 years in life sciences, including 7 in clinical research and at least 4 in study management.
Knowledge/Skills
- Experience starting/maintenance/close-out; protocol development.
- Clinical expertise in complex multinational trials; independent preparation of IND/BLA/NDA clinical sections.
- Clear written/presentation skills on scientific/clinical topics; strong matrix leadership.
Working Conditions
- Onsite in Alameda, CA; travel up to 20%.
Benefits
- 401k (company contributions), medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus.
Application instructions
- Not provided in text.
- The Senior Clinical Trials Manager, Clinical Operations, serves as Study Delivery Lead (SDL), accountable for end-to-end planning, execution, and reporting of clinical trials through time, quality, budget, company standards, and protocol requirements.
Essential Duties and Responsibilities
- Own global study delivery strategy and overall study deliverables (e.g., country selection, diversity, patient engagement, recruitment).
- Assess, select, engage, manage, and oversee appropriate vendors (including CROs/contract labs).
- Ensure compliance with ICH/GCP, applicable laws/regulations, and company SOPs.
- Balance risk/benefit decisions; mitigate risks as needed.
- Develop/manage study-level budget within project allocation; prepare materials for governance/financial reviews.
- Lead investigator and other study meetings; participate in governance meetings.
- Identify and communicate resource gaps; lead risk management and quality/inspection readiness.
- Lead/contribute to ways of working and process improvement; provide clinical operational input into protocol development.
- Partner with Data Management and Clinical Sciences on data cleaning strategy.
- As SDL, lead the Study Delivery Team (SDT) and partner across functions to support patient-centric documents and reduce patient burden.
- Provide proactive oversight of vendor performance and deliver study status updates.
Education/Experience (Required)
- BA/BS + 9+ years relevant experience; or MA/MS + 7+; or PhD/PharmD + 2+; or equivalent.
Experience (Preferred/Ideal)
- Minimum 9 years in life sciences, including 7 in clinical research and at least 4 in study management.
Knowledge/Skills
- Experience starting/maintenance/close-out; protocol development.
- Clinical expertise in complex multinational trials; independent preparation of IND/BLA/NDA clinical sections.
- Clear written/presentation skills on scientific/clinical topics; strong matrix leadership.
Working Conditions
- Onsite in Alameda, CA; travel up to 20%.
Benefits
- 401k (company contributions), medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus.
Application instructions
- Not provided in text.