Senior Director Of Clinical Affairs

2 weeks ago

Carlsbad, United States Talnt Full time

About 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 leader capable of navigating the complexities of clinical program management from overseeing study protocols and regulatory submissions to ensuring effective crossfunctional 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 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 crossfunctional collaboration between teams such as sales marketing R&D legal and laboratory operations to ensure smooth clinical study .
  • 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 companys 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 CLIAcertified 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 evidencebased 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 fastpaced startup environments.

  • Bonus
  • Equity
  • Relocation Assistance
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Remote Work :

No

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