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.
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