Patient Recruitment & Retention Strategy & ICF Governance Director (Biotech / Oncology)
Exelixis
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Benefits offered by this job
Job summary
Exelixis seeks a leader to drive the global informed consent program, ensuring alignment with regulatory standards and trial requirements. You will manage cross-functional governance with internal teams, CROs, vendors, and sites to meet enrollment and retention goals.
You will update templates to reflect latest guidance, maintain ICH/GCP compliance, and support inspection activities while partnering with study delivery leaders to keep trials on schedule.
Qualifications
- Minimum 13 years of related experience with BS/BA or 11 years with MS/MA.
- Experience across tumor indications and clinical trial phases.
- Experience in electronic data management.
- Experience reducing patient and site burden during clinical trials.
- Experience partnering with sites is a plus.
Responsibilities
- Lead cross-functional governance and informed consent programs across trials.
- Ensure ICH/GCP compliance in all consent processes and forms.
- Collaborate with CROs to align processes and templates with Exelixis standards.
- Develop tactics to recruit and retain participants and engage under-represented populations.
- Assist in health authority inspections and corporate initiatives as needed.
Skills
Education
Job description
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.
- Partners cross-functionally and with study teams to execute the methodology for delivering the portfolio of studies within the defined budgets and timelines. This includes, but is not limited to
- 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
- None.
- 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.
- Experience partnering closely and building relationships with sites is a plus.
- 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.
#LI-JD1
Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $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.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package,
- 401k plan with generous company contributions
- group medical
- dental and vision coverage
- life and disability insurance
- flexible spending accounts
- discretionary annual bonus program
- sales-based incentive plan (if field sales staff)
- opportunity to purchase company stock
- receive long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- up to 10 sick days throughout the calendar year
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