Senior Director of Clinical Affairs

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Job description

About the Role

As the Senior Director of Clinical Affairs, you will spearhead clinical collaboration programs, driving forward innovative oncology-focused research. You will be responsible for building and managing relationships with academic institutions, research groups, and community practices to execute impactful clinical studies. This role requires a strong leader capable of navigating the complexities of clinical program management, from overseeing study protocols and regulatory submissions to ensuring effective cross-functional collaboration. You will also contribute to publication planning, regulatory strategy, and medical reviews, playing a key role in advancing the companys clinical and business goals.

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 the company's 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.

Bonus'

Equity

Relocation Assistance

401(k)

401(k) matching

Dental insurance

Health insurance

Life insurance

Paid time off

Vision insurance

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