Senior Director of Clinical Affairs

1 month ago


Carlsbad, United States Talnt Full time
About the Role

We are seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical collaboration programs and drive forward innovative oncology-focused research. As a key member of our team, you will be responsible for building and managing relationships with academic institutions, research groups, and community practices to execute impactful clinical studies.

Key Responsibilities
  • Lead the planning, execution, and management of clinical collaboration programs with key stakeholders in academic institutions, research groups, and community oncology practices.
  • Oversee all clinical program deliverables, including study protocols, contracts, timelines, budgets, and risk management plans.
  • Manage effective cross-functional collaboration between teams such as sales, marketing, R&D, legal, and laboratory operations to ensure smooth clinical study execution.
  • Contribute to the development and implementation of scientific publication plans to support consistent communication of clinical findings.
  • Assist in the preparation and review of regulatory documents, ensuring compliance with clinical and regulatory standards.
  • Serve as a medical reviewer on promotional and medical review committees to maintain scientific accuracy and regulatory adherence.
  • Develop strategies to communicate the clinical and payer value of our technologies and products.
  • Maintain active oversight of clinical trials, ensuring alignment with project timelines, goals, and regulatory requirements.
Qualifications
  • Advanced scientific or medical degree (PhD, PharmD, MD, DO, NP/PA, or international equivalent).
  • Proven experience leading clinical research programs, with a focus on genomics, diagnostics, oncology, or related medical fields.
  • Prior experience within CLIA-certified laboratories preferred; relevant experience in IVD, pharmaceuticals, biologics, or medical devices also considered.
  • Strong understanding of the US healthcare system, including academic and clinical research settings.
  • Demonstrated ability to build relationships with investigators, clinical collaborators, and research institutions.
  • Proficient in balancing business and scientific perspectives to meet clinical and corporate objectives.
  • Knowledge of evidence-based medicine, biostatistics, and health economics is a plus.
  • Strong project management skills, with the ability to handle multiple projects simultaneously and communicate effectively across all organizational levels.
  • Proficiency in Microsoft Office programs (Word, Excel, PowerPoint).
Preferred Qualifications
  • Experience in clinical trials within genomics or oncology.
  • Familiarity with CLIA laboratories and regulatory submission processes.
  • Prior leadership experience in fast-paced startup environments.
What We Offer
  • Bonus
  • Equity
  • Relocation Assistance
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance


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