Easter Seals Jobs

Reference #: JR5957 SUMMARY/JOB PURPOSE:

The Patient Recruitment and Retention Strategy Director builds and establishes Exelixis' strategy for the development and execution of customized and appropriately represented clinical trial recruitment. This role collaborates effectively and partners with Exelixis Research and Development's multi-year vision for health equity and ensures clinical trials are properly diverse and inclusive. This strategy drives community relationships, awareness, health literacy, influence program/study design, clinical trial patient experience, and clinical trial participant expected outcomes that will ultimately transform the success of participation and retention of diverse populations that are representative of the global epidemiology of the disease states where we are pursuing. Collaboration across key development and functional areas is critical (e.g., Real World Evidence, Development Operations, Product Development & Medical Affairs, Clinical Development, Regulatory Affairs, Digital Technology, Public Affairs and Government Affairs, and Patient Advocacy). The Patient Recruitment and Retention Strategy Director, in collaboration with key leadership across Product Development & Medical Affairs, ensures that Equity, Diversity & Inclusion is embedded in the way Exelixis conducts research. This role creates, builds, and leads the implementation of the strategy while establishing the internal and external awareness of the importance of equity, diversity, and inclusion in clinical trials. The leader identifies and implements process changes required to increase participation of diverse populations in trials and collaborates effectively with external parties (CROs, vendors, and sites) to ensure that clinical trials meet their enrollment and participant diversity goals. The Patient Recruitment and Retention Strategy Director works with development teams in data-driven planning to set demographic targets, oversees program-level strategies to meet those targets, and enables teams through innovative approaches to implement the strategies throughout the execution of the trial. The Patient Recruitment and Retention Strategy Director partners closely with the Head of Study Optimization, Clinical Operations, to develop and execute the strategy, framework, and 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 Director preferably has experience in clinical research with experience in healthcare, life sciences, regulatory, data science, public health, epidemiology, computer science, or other global clinical development roles. Specific expertise in patient experience, community partnerships, clinical trial design, and digital health are vital for the success of the role. The responsibilities of this role are executed across all phases and therapeutic areas to integrate D&I into clinical trials at Exelixis. The Director must have extensive experience implementing organizational change management techniques across a highly matrixed, large healthcare system, hospital, network of clinics, or biopharmaceutical company.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Develop and oversee the deployment of effective patient recruitment and retention strategies across the Exelixis clinical trial portfolio. Evaluate and implement novel patient recruitment strategies to achieve overall enrollment and demographic targets. Serve as the Clinical Trial Diversity & Inclusion expert and liaison to key functional areas including but not limited to Clinical Operations, Clinical Development, Product Development, Medical Affairs, Public Affairs, Regulatory Affairs, Government Affairs, and Development Operations. Drive 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. Facilitate the selection and management of 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 planning and implementation. Oversee the development of study awareness, recruitment, and retention materials. Work with study teams, clinical research sites, and others to identify opportunities for outreach and study awareness activities. Work with internal and external stakeholders to develop tactics in reaching recruitment goals. Develop and maintain patient recruitment channels with external partners. Collaborate with Clinical Operations Leadership Team and Study Delivery Leads to develop a repository of recruitment/study awareness materials and tools. Lead and support study awareness activities that may include participation at congressional, regional, and local meetings. Support Exelixis Public Relations and external corporate giving, or Employee Resource Group (ERG) initiatives (e.g., community service). Inform corporate and regulatory strategy policies as it relates to Diversity & Inclusion in clinical trials.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

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/The Ideal for Successful Entry into Job:

Typically requires at least 8 years of experience in developing and implementing clinical trial recruitment and diversity plans.

Knowledge/Skills:

Demonstrated leadership, especially in complex matrix run organizations. Has extensive experience in clinical trial diversity and inclusion plans. Ability to develop technical and/or business solutions to complex problems, including challenges to recruit for clinical trials. Expert 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 determine organizational or team objectives and interpret company policies. 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 a major impact on the company's ability to deliver products and solutions to ensure health equity across a diverse and representative patient population. Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.

EXHIBITS EXELIXIS LEA