Patient Recruitment & Retention Strategy & ICF Governance 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. The responsibilities of this role are executed across all programs, phases and therapeutic areas in clinical trials at Exelixis.

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.
• Development of enabling policies and procedures aligned with emerging external laws and guidance (e.g., ICH E6R3 Guidance)
• Utilization of key data assets
• Creation of targets or key performance indicators
• Methods to enable appropriate and durable engagement in under-represented people including, but not limited to, the usage of decentralized/direct-to-patient models.
• Lead informed consent cross-functional governance team and informed consent reviews.
• Evaluate and update generic informed consent templates to ensure alignment with latest global guidance and requirements.
• Work with CROs to understand CRO processes and train on Exelixis process and templates.
• Maintain ICH/GCP compliance, ensuring quality in every element of our informed consent process and forms.
• Collaborate with Study Delivery Leads to ensure timelines are met.
• Work with internal and external stakeholders to develop tactics in reaching recruitment and retention goals, including more patient friendly study documents.
• Develop a repository of information gathered from informed consent global submissions to integrate into updated templates in an effort to expedite study timelines.
• Participate in health authority inspections and activities as appropriate.
• Support 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

Supervisory Responsibilities

None.

Education/Experience/Knowledge/Skills & Abilities

Education

• 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.

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.

Knowledge, Skills and Abilities

Required:

• Leadership and collaboration in complex matrix run organizations.
• Ability to think through, provide solutions and innovate to recruit and retain participants for clinical trials.
• Knowledge of GCP and regulatory requirements related to 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 a wide degree of creativity and latitude.
• Applies strong analytical and business communication skills.