Patient Recruitment & Retention Strategy & ICF Governance Director (Biotech / Oncology)
Exelixis
August 19, 2026
On-site
Alameda, CA
Clinical Research and Development
Summary/Job Purpose:
Leads the implementation of the recruitment and retention strategy, ensuring adherence to global requirements across informed consent forms and clinical trials. Leads a cross-functional governance team and collaborates with internal/external partners (CROs, vendors, sites) to meet enrollment and retention goals across all programs, phases, and therapeutic areas.
Essential Duties/Responsibilities:
- Partner cross-functionally to execute portfolio study delivery within budgets and timelines, including enabling policies/procedures (e.g., ICH E6R3 guidance), use of key data assets, KPI/target creation, and engagement methods for under-represented people (e.g., decentralized/direct-to-patient models).
- Lead informed consent cross-functional governance team and informed consent reviews.
- Evaluate and update generic informed consent templates to align with current global guidance/requirements.
- Work with CROs to understand CRO processes and train on Exelixis processes/templates.
- Maintain ICH/GCP compliance and quality across informed consent process/forms.
- Collaborate with Study Delivery Leads to ensure timelines.
- Develop tactics with stakeholders to reach recruitment/retention goals, including more patient-friendly study documents.
- Build a repository of informed consent submission learnings to expedite updates.
- Participate in health authority inspections as appropriate.
- Support external corporate giving or ERG initiatives (e.g., community service).
Qualifications:
- BS/BA in Science/Business/related + 13+ years; or MS/MA + 11+ years; or equivalent.
- Typically 6+ years in global informed consent processes/forms.
- Experience across tumor indications and clinical trial phases.
- Experience in electronic data management.
- Experience reducing patient and site burden; site partnership experience is a plus.
- Required skills: leadership/collaboration in matrix organizations; ability to innovate for recruitment/retention; knowledge of GCP and global regulatory requirements; ability to define/implement methods and evaluation criteria; strong analytical and business communication skills.
Leads the implementation of the recruitment and retention strategy, ensuring adherence to global requirements across informed consent forms and clinical trials. Leads a cross-functional governance team and collaborates with internal/external partners (CROs, vendors, sites) to meet enrollment and retention goals across all programs, phases, and therapeutic areas.
Essential Duties/Responsibilities:
- Partner cross-functionally to execute portfolio study delivery within budgets and timelines, including enabling policies/procedures (e.g., ICH E6R3 guidance), use of key data assets, KPI/target creation, and engagement methods for under-represented people (e.g., decentralized/direct-to-patient models).
- Lead informed consent cross-functional governance team and informed consent reviews.
- Evaluate and update generic informed consent templates to align with current global guidance/requirements.
- Work with CROs to understand CRO processes and train on Exelixis processes/templates.
- Maintain ICH/GCP compliance and quality across informed consent process/forms.
- Collaborate with Study Delivery Leads to ensure timelines.
- Develop tactics with stakeholders to reach recruitment/retention goals, including more patient-friendly study documents.
- Build a repository of informed consent submission learnings to expedite updates.
- Participate in health authority inspections as appropriate.
- Support external corporate giving or ERG initiatives (e.g., community service).
Qualifications:
- BS/BA in Science/Business/related + 13+ years; or MS/MA + 11+ years; or equivalent.
- Typically 6+ years in global informed consent processes/forms.
- Experience across tumor indications and clinical trial phases.
- Experience in electronic data management.
- Experience reducing patient and site burden; site partnership experience is a plus.
- Required skills: leadership/collaboration in matrix organizations; ability to innovate for recruitment/retention; knowledge of GCP and global regulatory requirements; ability to define/implement methods and evaluation criteria; strong analytical and business communication skills.