Patient Recruitment & Retention Strategy Director – Biotech, Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the execution of recruitment and retention strategies across various clinical trial programs, phases, and therapeutic areas.

• Ensure compliance with global standards and guidelines pertaining to informed consent forms and clinical trials.

• Lead a cross-functional governance team focused on informed consent and manage informed consent reviews.

• Collaborate with both internal teams and external partners, such as CROs, vendors, and sites, to meet enrollment and retention objectives.

• Work alongside study teams to deliver the portfolio of studies within established budgets and timelines.

• Create policies and procedures that align with evolving external regulations and guidance, including ICH E6R3.

• Leverage key data assets to establish targets and key performance indicators.

• Develop strategies to engage under-represented populations effectively, incorporating decentralized and direct-to-patient models.

• Review and update generic informed consent templates to ensure alignment with global guidance and requirements.

• Collaborate with CROs to comprehend their processes and provide training on Exelixis methodologies and templates.

• Ensure ICH/GCP compliance and uphold quality throughout the informed consent process and associated forms.

• Partner with Study Delivery Leads to adhere to project timelines.

• Formulate strategies with stakeholders to achieve recruitment and retention targets, including the creation of patient-friendly study documentation.

• Maintain a comprehensive repository of global informed consent submission information to facilitate quicker study timelines.

• Engage in health authority inspections and related activities.

• Assist Exelixis Public Relations, external corporate giving, and Employee Resource Group initiatives.

• Perform additional duties as assigned.

• Adhere to all organizational policies and standards.

• No supervisory responsibilities.

⛳️ Requirements

• Bachelor's or Master's degree in Science, Business, or a related field, along with a minimum of 13 years or 11 years of relevant experience, respectively; or an equivalent combination of education and experience.

• Certification in the designated area may be required.

• Generally requires at least 6 years of experience with the global informed consent process and forms.

• Experience across various tumor indications and clinical trial phases.

• Familiarity with electronic data management systems.

• Proven track record of minimizing both patient and site burdens during clinical trials.

• Comprehensive knowledge of GCP and regulatory standards for conducting clinical trials globally.

• Experience in leadership and collaboration within complex, matrix-driven organizations.

• Ability to devise innovative solutions for recruiting and retaining clinical trial participants.

• Capability to identify and implement methods, techniques, procedures, and evaluation criteria to achieve desired outcomes.

• Proficiency in prioritizing and executing complex tasks creatively and with flexibility.

• Strong analytical skills and effective business communication abilities.

• Experience in building close partnerships with sites is advantageous.

🏝️ Benefits

• 401k plan with generous contributions from the company.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance offerings.

• Flexible spending accounts available.

• Participation in a discretionary annual bonus program.

• Opportunity to purchase stock in the company.

• Long-term incentive plans.

• 15 vacation days accrued in the first year.

• 17 paid holidays, including a company-wide winter shutdown in December.

• Up to 10 sick days allowed throughout the year.

• Provision of essential equipment, including dual monitors and ergonomic chairs.

• Disability accommodations provided during the recruitment process.