Senior Director of Clinical Affairs
1 month ago
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.
- 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).
- 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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Senior Director Of Clinical Affairs
2 months ago
Carlsbad, United States Talnt Full timeAbout the Role As the Senior Director of Clinical Affairs you will spearhead clinical collaboration programs driving forward innovative oncologyfocused 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...
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Senior Director Of Clinical Affairs
1 month ago
Carlsbad, United States Talnt Full timeAbout the Role As the Senior Director of Clinical Affairs you will spearhead clinical collaboration programs driving forward innovative oncologyfocused 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...
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Carlsbad, United States Talnt Full timeAbout the RoleWe are seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical collaboration programs, driving 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...
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