Associate Patient Recruitment & Retention Strategy Director (Oncology / Biotech)

SUMMARY/JOB PURPOSE:

Join a Team that has a Direct Connect to Cancer Patients! The Associate Patient Recruitment and Retention Strategy Director is involved in executing Exelixis' comprehensive strategy for clinical trial recruitment and retention across Exelixis' pipeline. In this role, there is an opportunity for developing and implementing patient support materials, community outreach initiatives, and standard procedures that may be applied across programs to better support Patient Recruitment and Retention efforts. There is also an opportunity to develop a strategic approach in integrating the patient voice across our clinical trials. This role is an active member of the Clinical Operations Team and collaborates effectively across the Exelixis organization (e.g., Program Leadership, Medical Affairs, Product Development, Clinical Development, Regulatory Affairs, Digital Technology, Public Affairs and Government Affairs, and Patient Advocacy) to ensure clinical trials are feasible, patient-centric, and properly diverse and inclusive.

This role leads the implementation of the recruitment and retention strategy while ensuring the internal and external awareness of the importance of equity, diversity, and inclusion in clinical trials. The individual is responsible for recruitment and retention materials required to increase participation and retention in trials and collaborates effectively with internal and external parties (CROs, vendors, and sites) to ensure that clinical trials meet their enrollment and retention goals. Efforts in capturing and understanding data elements as relates to patient recruitment and retention is also needed. This role has an opportunity to span into Informed Consent and re-consent of participants, with the ability to innovate in both of these remits.

The Associate Patient Recruitment and Retention Strategy Director 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, the development of enabling policies and procedures aligned with emerging external laws and guidance (e.g., PDUFA 7, CURES ACT 2.0, DEPICT Act, ICH E17 Guidance), utilization of key data assets, the inclusion of relevant epidemiology data, creation of targets or key performance indicators, and methods to enable appropriate and durable engagement in under-represented people including, but not limited to, the usage of decentralized/direct-to-patient models.

The Associate Director has experience in clinical research (preferably Late-Phase) with experience in healthcare, life sciences, data science, public health, epidemiology, or other global clinical development roles. Specific expertise in patient experience, recruitment initiatives, retention, community partnerships, clinical trial design, and digital health are vital for the success of the role. Partnering closely and building relationships with Sites is also a plus. The responsibilities of this role are executed across all phases and therapeutic areas to integrate D,E,&I into clinical trials at Exelixis.

*** Please note this role is an office-based position that can be located in either Alameda, CA or King of Prussia, PA. Exelixis offers a full relocation benefit.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Deploy effective patient recruitment and retention strategies across the Exelixis clinical trial portfolio.
• Evaluate and implement novel patient recruitment and retention strategies to achieve overall enrollment and demographic targets.
• Implement the patient strategy for incorporating the Equity, Diversity & Inclusion corporate objectives into clinical programs and trial designs.
• Partner with the Digital Technology to develop AI/ML techniques, develop market-driven research, decentralized approaches, and other capabilities to increase access to and engagement with clinical trials for representative populations.
• Work with vendors that support recruitment activities. Routinely assess vendor performance based on recruitment and retention metrics.
• In collaboration with Exelixis Patient Advocacy, ensure that strategies are effective in reaching and engaging the targeted patient population and are capturing the Patient Experience and Voice.
• Collaborate with Study Delivery Leads to ensure effective site-specific recruitment and retention planning and implementation.
• Oversee the development of study awareness, recruitment, and retention materials.
• Work with internal and external stakeholders to develop tactics in reaching recruitment and retention goals, including more 'patient friendly' study documents.
• Collaborate with Clinical Operations Team and Study Delivery Leads to develop a repository of recruitment/study awareness materials and tools.
• Support Exelixis Public Relations and external corporate giving, or Employee Resource Group (ERG) initiatives (e.g., community service).

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in Science, Business, or related discipline and a minimum of 11 years of related experience; or,
• MS/MA degree in Science, Business, or related discipline and a minimum of 9 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Typically requires at least 6 years of experience in developing and implementing clinical trial recruitment and diversity plans.

Knowledge/Skills:

• Collaboration in complex matrix run organizations.
• Has experience across different tumor indications, clinical trial phases, and in clinical trial diversity and inclusion.
• Ability to think through, provide solutions, and innovate to recruit and retain participants for clinical trials.
• Knowledge of GCP and regulatory requirements related to the conducting clinical trials worldwide.
• Ability to identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
• Ability to perform a variety of complicated tasks with a wide degree of creativity and latitude.
• Applies strong analytical and business communication skills.

JOB COMPLEXITY:

• Has an impact on the company's ability to deliver products and solutions to ensure health equity across a diverse and representative patient population.
• Exercises judgment in methods, techniques, and evaluation of criteria for obtaining results.

EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS:

• We drive for results so patients can survive and thrive.
• We are resilient in the face of adversity and tireless in advancing our science.
• We celebrate our long history of prolific drug discovery and rigorous drug development.
• We unite to launch innovative medicines for difficult-to-treat cancers.
• We exist to give people hope - one drug, one patient at a time.
• We are Exelixis.

LIVES THE EXELIXIS CORE VALUES DAILY:

• Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way)
• Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results)
• Excel for Patients (Innovate to design solutions and remove barriers to show how much we care)

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work
• Must be able to co-locate to the Alameda, CA or King of Prussia, PA offices and meet the minimum on-site attendance policy.