Clinical Trials Manager (Oncology)
Exelixis
June 26, 2026
On-site
Alameda, CA
Clinical Research and Development
SUMMARY/JOB PURPOSE
- Coordinates the evaluation, initiation, and management of solid tumor oncology clinical trials.
- Oversees execution of clinical trials, CRO oversight, and provides operational support to the Study Delivery Lead (SDL).
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manages clinical trials, including via CROs.
- Provides operational strategies with cross-functional teams.
- Owns at least one geographical region and manages 1–3 external vendors (e.g., lab) within scope.
- Manages CRO/vendor/site relationships and ensures quality/performance.
- Provides CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review, etc.).
- Contributes to Study Delivery Team (SDT) meetings and Investigator Meetings.
- Supports feasibility assessments and site selection.
- Supports protocol development; reviews ICFs, CRFs, monitoring plans, and other study materials.
- Maintains contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensures site adherence to protocol and ICH-GCP; identifies/escalates issues and drives risk mitigation.
- Supports compliance (e.g., Verification of Performance/VOP) and oversight of regulatory/essential documents.
- Supports development of study documents (VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, User Manuals) and study guides/subject instructions.
- May support governance discussions and invoice review; reviews study trackers/metrics.
- May mentor and train Sr. Clinical Trial Specialists (CTS).
SUPERVISORY RESPONSIBILITIES
- None.
EDUCATION/EXPERIENCE
- BA/BSN in biological sciences or related: 7+ years related experience; OR MS/MA/MSN: 5+; OR PhD/PharmD: 0+; OR equivalent combination.
IDEAL EXPERIENCE
- Minimum 7 years in life sciences, including 5 years in clinical research.
KNOWLEDGE/SKILLS (required)
- Experience across study start-up, maintenance, and/or close-out.
- Prospective site-selection criteria; protocol development.
- Working knowledge of ICH-GCP, local regulations, SOPs, and study procedures.
- Experience with CRO/contract lab interactions; site IC adequacy review.
- Ability to write/present scientific/clinical content; strong organization, planning, communication, and problem-solving.
PREFERRED/OTHER
- Ability to anticipate/resolve issues; work in matrix environment.
WORKING CONDITIONS
- Travel up to 20% for clinical study activities.
APPLICATION INSTRUCTIONS
- For disability accommodations related to application/recruitment: recruiting@exelixis.com.
- Coordinates the evaluation, initiation, and management of solid tumor oncology clinical trials.
- Oversees execution of clinical trials, CRO oversight, and provides operational support to the Study Delivery Lead (SDL).
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manages clinical trials, including via CROs.
- Provides operational strategies with cross-functional teams.
- Owns at least one geographical region and manages 1–3 external vendors (e.g., lab) within scope.
- Manages CRO/vendor/site relationships and ensures quality/performance.
- Provides CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review, etc.).
- Contributes to Study Delivery Team (SDT) meetings and Investigator Meetings.
- Supports feasibility assessments and site selection.
- Supports protocol development; reviews ICFs, CRFs, monitoring plans, and other study materials.
- Maintains contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensures site adherence to protocol and ICH-GCP; identifies/escalates issues and drives risk mitigation.
- Supports compliance (e.g., Verification of Performance/VOP) and oversight of regulatory/essential documents.
- Supports development of study documents (VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, User Manuals) and study guides/subject instructions.
- May support governance discussions and invoice review; reviews study trackers/metrics.
- May mentor and train Sr. Clinical Trial Specialists (CTS).
SUPERVISORY RESPONSIBILITIES
- None.
EDUCATION/EXPERIENCE
- BA/BSN in biological sciences or related: 7+ years related experience; OR MS/MA/MSN: 5+; OR PhD/PharmD: 0+; OR equivalent combination.
IDEAL EXPERIENCE
- Minimum 7 years in life sciences, including 5 years in clinical research.
KNOWLEDGE/SKILLS (required)
- Experience across study start-up, maintenance, and/or close-out.
- Prospective site-selection criteria; protocol development.
- Working knowledge of ICH-GCP, local regulations, SOPs, and study procedures.
- Experience with CRO/contract lab interactions; site IC adequacy review.
- Ability to write/present scientific/clinical content; strong organization, planning, communication, and problem-solving.
PREFERRED/OTHER
- Ability to anticipate/resolve issues; work in matrix environment.
WORKING CONDITIONS
- Travel up to 20% for clinical study activities.
APPLICATION INSTRUCTIONS
- For disability accommodations related to application/recruitment: recruiting@exelixis.com.