Foresite Labs · 1 month ago
Clinical Development Director
San Diego, CA
Full-time
Onsite
Director/Executive
$194K/yr - $251K/yr
7+ years expForesite Labs is seeking a Director of Clinical Affairs to lead the development and monitoring of novel clinical studies for their clinical genomics applications. This role involves establishing the clinical affairs function, driving clinical product line strategies, and ensuring compliance with clinical quality standards.
BiopharmaBiotechnologyHealth CareMedical
Responsibilities
Lead the development and execution of clinical affairs strategy for testing services
Oversee clinical validation studies to support regulatory submissions, reimbursement, and publication
Collaborate with R&D, bioinformatics, and laboratory operations to ensure clinical relevance and robustness of test development
Design and manage investigator-initiated and company-sponsored clinical studies
Drive data collection, analysis, and dissemination to demonstrate clinical validity and utility
Develop and execute publication strategy, including peer-reviewed manuscripts, posters, and conference presentations
Build and manage relationships with oncologists, pathologists, and key opinion leaders (KOLs)
Serve as the company’s clinical liaison to academic institutions, cooperative groups, and biopharma partners
Represent the company at scientific and clinical conferences
Partner with regulatory affairs to support FDA, CAP/CLIA, and other applicable submissions
Ensure compliance with ethical, legal, and regulatory standards in all clinical activities
Contribute to payer dossiers and evidence packages to support market access
Qualification
Required
Advanced clinical degree (PhD, or equivalent experience) required
7+ years of experience in clinical affairs, medical affairs, or translational research
Demonstrated success in designing and executing clinical validation and utility studies
Experience with CLIA/CAP labs and/or regulatory submissions (FDA, EMA) a strong plus
Strong publication record and experience presenting at scientific conferences
Excellent communication, leadership, and cross-functional collaboration skills
Entrepreneurial mindset and ability to operate effectively in a fast-paced, resource-constrained start-up environment
Bachelor's Degree in biological sciences or equivalent is required
Preferred
Advanced degree and/or MBA is preferred
Company
Foresite Labs
Foresite Labs is a biotechnology company. It is a sub-organization of Foresite Capital.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Alex Blocker
CTO and Chief Data Scientist
Uplaksh Kumar
COO Foresite Labs and Venture Partner Foresite Capital
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