Patient Recruitment & Retention Strategy Director (Biotech / Oncology)

Summary/Job Purpose

Leads the implementation of the recruitment and retention strategy while ensuring adherence to global requirements and guidelines across our informed consent forms and clinical trials. Leads a cross-functional governance team and collaborates effectively with internal and external parties (CROs, vendors and sites) to ensure that clinical trials meet their enrollment and retention goals.

Essential Duties/Responsibilities

• Partners cross-functionally and with study teams to execute the methodology for delivering the portfolio of studies within the defined budgets and timelines.
• Develops enabling policies and procedures aligned with emerging external laws and guidance (e.g., ICH E6R3 Guidance).
• Utilizes key data assets.
• Creates targets or key performance indicators.
• Develops methods to enable appropriate and durable engagement in under-represented people, including the usage of decentralized/direct-to-patient models.
• Leads informed consent cross-functional governance team and informed consent reviews.
• Evaluates and updates generic informed consent templates to ensure alignment with latest global guidance and requirements.
• Works with CROs to understand CRO processes and train on Exelixis process and templates.
• Maintains ICH/GCP compliance, ensuring quality in every element of our informed consent process and forms.
• Collaborates with Study Delivery Leads to ensure timelines are met.
• Collaborates with internal and external stakeholders to develop tactics in reaching recruitment and retention goals, including more patient-friendly study documents.
• Develops a repository of information gathered from informed consent global submissions to integrate into updated templates in an effort to expedite study timelines.
• Supports Exelixis Public Relations and external corporate giving, or Employee Resource Group (ERG) initiatives (e.g., community service).
• Performs other duties as assigned.
• Complies with all policies and standards.

Education/Experience/Knowledge/Skills & Abilities

• 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.
• 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.
• Experience partnering closely and building relationships with sites is a plus.

Compensation

The base pay range for this position is $164,500 - $234,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.