Patient Recruitment & Retention Strategy Director – Biotech, Oncology

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $185k - $234.5k / year

⏰ Full Time

🔴 Lead

🧐 Strategy

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Exelixis

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1994

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $65M Post-IPO Equity on 2012-02

Healthcare • Biotechnology • Pharmaceuticals

Exelixis is a biotechnology and pharmaceutical company focused on developing cancer treatments through innovative research and development. The company is committed to advancing oncology by creating impactful cancer medicines, including biotherapeutics and small molecule therapies. Exelixis places a strong emphasis on clinical trials, collaborations, and a diverse range of treatment modalities, aiming to provide hope to cancer patients. Additionally, Exelixis is dedicated to sustainability, diversity, and community support, as reflected in their corporate values and practices.

📋 Description

• Lead implementation of recruitment and retention strategy across clinical trial programs, phases and therapeutic areas • Ensure adherence to global requirements and guidelines for informed consent forms and clinical trials • Lead a cross-functional informed consent governance team and informed consent reviews • Collaborate with internal and external parties, including CROs, vendors and sites, to achieve enrollment and retention goals • Partner with study teams to deliver the portfolio of studies within defined budgets and timelines • Develop enabling policies and procedures aligned with emerging external laws and guidance, including ICH E6R3 • Utilize key data assets and create targets or key performance indicators • Develop methods for durable engagement of under-represented people, including decentralized/direct-to-patient models • Evaluate and update generic informed consent templates to align with global guidance and requirements • Work with CROs to understand their processes and train them on Exelixis processes and templates • Maintain ICH/GCP compliance and quality throughout the informed consent process and forms • Collaborate with Study Delivery Leads to meet timelines • Develop tactics with stakeholders to reach recruitment and retention goals, including patient-friendly study documents • Maintain a repository of global informed consent submission information to expedite study timelines • Participate in health authority inspections and related activities • Support Exelixis Public Relations, external corporate giving and Employee Resource Group initiatives • Perform other duties as assigned • Comply with all policies and standards • No supervisory responsibilities

🎯 Requirements

• 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 • Knowledge of GCP and regulatory requirements related to conducting clinical trials worldwide • Leadership and collaboration in complex matrix-run organizations • Ability to develop solutions and innovate to recruit and retain clinical trial participants • Ability to identify and implement methods, techniques, procedures and evaluation criteria to achieve results • Ability to prioritize and perform complicated tasks with creativity and latitude • Strong analytical and business communication skills • Experience partnering closely and building relationships with sites is a plus

🏖️ Benefits

• 401k plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Opportunity to purchase company stock • Long-term incentives • 15 accrued vacation days in the first year • 17 paid holidays including a company-wide winter shutdown in December • Up to 10 sick days throughout the calendar year • Necessary equipment, including dual monitors and ergonomic chairs • Disability accommodation during the recruiting process