Patient Recruitment & Retention Strategy & ICF Governance Director (Biotech / Oncology)

Exelixis • Alameda, CA

8d • $185,000 - $234,500 • Remote

About The Position

Leads implementation of recruitment and retention strategies and ensures adherence to global requirements and guidelines for informed consent forms and clinical trials. This role leads a cross-functional governance team and works with internal and external stakeholders, including CROs, vendors, and sites, to help clinical trials meet enrollment and retention goals. Responsibilities span all programs, phases, and therapeutic areas at Exelixis.

The role partners with study teams to deliver the portfolio of studies within defined budgets and timelines. It develops policies and procedures aligned with emerging external laws and guidance, uses key data assets, establishes targets or key performance indicators, and enables appropriate, durable engagement of under-represented people, including through decentralized and direct-to-patient models. It leads informed consent governance and reviews, updates generic consent templates, works with CROs on processes and training, and maintains ICH/GCP compliance and quality in the informed consent process.

The position collaborates with Study Delivery Leads and stakeholders to meet timelines and recruitment and retention goals, including by developing more patient-friendly study documents. It builds a repository of information from global informed consent submissions to support template updates and expedite study timelines, and participates in health authority inspections and activities as appropriate. It may also support public relations, external corporate giving, or Employee Resource Group initiatives, and performs other assigned duties while complying with company policies and standards.

The position is remote. The listed base salary range is $185,000–$234,500. Exelixis offers a comprehensive benefits package, including retirement, insurance, incentive, leave, and other programs.

Requirements

• BS/BA in Science, Business, or a related discipline and at least 13 years of related experience; or an MS/MA in Science, Business, or a related discipline and at least 11 years of related experience; or an equivalent combination of education and experience.
• Typically, at least 6 years of experience in global informed consent processes and forms.
• Experience across different tumor indications and clinical trial phases.
• Experience in electronic data management.
• Experience reducing patient and site burden during clinical trials.
• Leadership and collaboration skills in complex matrix-run organizations.
• Ability to develop solutions and innovate to recruit and retain clinical trial participants.
• Knowledge of GCP and regulatory requirements for conducting clinical trials worldwide.
• Ability to identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
• Ability to prioritize and perform a variety of complicated tasks with creativity and latitude.
• Strong analytical and business communication skills.
• May require certification in the assigned area.

Nice To Haves

• Experience partnering closely with sites and building site relationships.

Responsibilities

• Lead implementation of recruitment and retention strategies across clinical trial programs, phases, and therapeutic areas.
• Partner with study teams to deliver the portfolio of studies within defined budgets and timelines.
• Develop enabling policies and procedures aligned with emerging external laws and guidance, including ICH E6R3 Guidance.
• Use key data assets and create targets or key performance indicators.
• Develop methods to enable appropriate and durable engagement of under-represented people, including through decentralized and direct-to-patient models.
• Lead the informed consent cross-functional governance team and informed consent reviews.
• Evaluate and update generic informed consent templates to align with current global guidance and requirements.
• Work with CROs to understand their processes and train them on Exelixis processes and templates.
• Maintain ICH/GCP compliance and quality throughout the informed consent process and forms.
• Collaborate with Study Delivery Leads to ensure timelines are met.
• Work with internal and external stakeholders to develop tactics for achieving recruitment and retention goals, including more patient-friendly study documents.
• Develop a repository of information from global informed consent submissions to inform updated templates and expedite study timelines.
• Participate in health authority inspections and activities as appropriate.
• Support Exelixis Public Relations, external corporate giving, or Employee Resource Group initiatives, such as community service.
• Perform other duties as assigned and comply with company policies and standards.

Benefits

• 401(k) plan with generous company contributions
• Group medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability insurance
• Flexible spending accounts
• Discretionary annual bonus program (or a sales-based incentive plan for field sales staff)
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in the first year
• 17 paid holidays, including a company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director