Clinical Development Director

We are seeking an Associate Director / Director of Clinical Affairs to lead the company's efforts to develop and monitor novel clinical studies to build clinical evidence in collaboration with the medical affairs, product management and R&D teams in the approach to our clinical genomics applications. This role will be responsible for establishing and leading a process to build the clinical affairs function as well as define the first clinical studies at this transformative company. The candidate will champion cross-functional initiatives to drive completion of clinical validations. The candidate will be instrumental in driving clinical product line strategies, and expanding market presence for our business.

The Director of Clinical Affairs will be responsible for planning, executing, and overseeing all clinical affairs activities related to the validation, clinical utility, and adoption of our product services. This role will bridge clinical, regulatory, and operational functions, ensuring our tests meet the highest standards of clinical quality, compliance, and scientific rigor. The ideal candidate is an experienced leader who thrives in a dynamic start-up environment and has a strong track record in molecular diagnostics and laboratory medicine.The ideal candidate is curious and a fast learner, unintimidated by climbing steep new learning curves and going deep into the details of a new technology.

Key Responsibilities

• Clinical Strategy & Operations

  • 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.

• Clinical Trial & Evidence Generation

  • 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.

• Medical & Scientific Engagement

  • 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.

• Regulatory & Compliance

  • 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.
    
    

Qualifications

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.

• Advanced degree and/or MBA is preferred

Location: San Diego, CA

Salary range: $194,258 - $250,637

We are an equal opportunity employer. We thrive on diversity and collaboration.