Patient Recruitment & Retention Strategy Director – Biotech, Oncology
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Job Description
Directing clinical-trial recruitment, retention, and informed-consent governance at Exelixis, an oncology biotech. Ensuring global compliance, patient engagement, and enrollment delivery across studies.
Responsibilities:
- Lead implementation of recruitment and retention strategy across clinical trial programs, phases and therapeutic areas
- Ensure adherence to global requirements and guidelines for informed consent forms and clinical trials
- Lead a cross-functional informed consent governance team and informed consent reviews
- Collaborate with internal and external parties, including CROs, vendors and sites, to achieve enrollment and retention goals
- 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
- Utilize key data assets and create targets or key performance indicators
- Develop methods for durable engagement of under-represented people, including decentralized/direct-to-patient models
- Evaluate and update generic informed consent templates to align with 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 meet timelines
- Develop tactics with stakeholders to reach recruitment and retention goals, including patient-friendly study documents
- Maintain a repository of global informed consent submission information to expedite study timelines
- Participate in health authority inspections and related activities
- Support Exelixis Public Relations, external corporate giving and Employee Resource Group initiatives
- Perform other duties as assigned
- Comply with all policies and standards
- No supervisory responsibilities
Requirements:
- BS/BA degree in Science, Business or related discipline and a minimum of 13 years of related experience; or MS/MA degree in Science, Business or related discipline and a minimum of 11 years of related experience; or equivalent combination of education and experience
- May require certification in assigned area
- Typically requires at least 6 years of experience in global informed consent process and forms
- Experience across different tumor indications and clinical trial phases
- Experience in electronic data management
- Experience reducing both patient and site burden during clinical trials
- Knowledge of GCP and regulatory requirements related to conducting clinical trials worldwide
- Leadership and collaboration in complex matrix-run organizations
- Ability to develop solutions and innovate to recruit and retain clinical trial participants
- Ability to identify and implement methods, techniques, procedures and evaluation criteria to achieve results
- Ability to prioritize and perform complicated tasks with creativity and latitude
- Strong analytical and business communication skills
- Experience partnering closely and building relationships with sites is a plus
Benefits:
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- 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
- Necessary equipment, including dual monitors and ergonomic chairs
- Disability accommodation during the recruiting process
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