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Executive Medical Director

2 months ago

Reston, Virginia, United States Biopretium Full time

Job Title: Senior Medical Director - Oncology

Location: Hybrid work environment with offices in various locations.

Reporting Line: Reporting into the Chief Medical Officer

Company Overview:

Biopretium is a biotech company founded in 2014 with headquarters in Washington state. Our company focuses on the development of therapies for oncology indications. With a substantial pipeline and over 30 active clinical trials, we are well-funded and positioned to make a significant impact on cancer treatment.

Position Summary and Key Responsibilities:

This role is responsible for overseeing the strategic direction, planning, and execution of clinical development programs. The individual will collaborate with cross-functional teams to deliver high-quality clinical data that supports both the scientific and business strategy of our products.

  • Lead the design and execution of clinical development programs, ensuring compliance with medical and regulatory standards. This includes overseeing education efforts for investigators, study site personnel, and internal teams.
  • Oversee the integrity and progress of clinical studies, ensuring the accumulation, analysis, and communication of data regarding the safety and efficacy of our compounds. Collaborate with Clinical Operations to ensure timely study enrollment and meet key milestones.
  • Accountable for serious adverse event assessments and regulatory reporting. Ensure all trial-related documents such as protocols, Investigator Brochures, and Clinical Study Reports are designed, analyzed, and reported appropriately.
  • Proactively monitor clinical trial safety, collaborating with safety teams to evaluate trial data and address safety concerns from investigators and regulatory bodies.
  • May manage the work of other Medical Directors and Clinical Scientists involved in the program.
  • Serve as the clinical expert on compounds and indications, liaising with internal stakeholders and providing scientific and medical guidance across projects.
  • Represent the company in clinical study teams and contribute to the development of cross-functional medical strategies, aligning with corporate policies.
  • Engage with key opinion leaders and maintain expertise in therapeutic areas by staying updated through medical literature and industry events.
  • Ensure compliance with regulatory standards, Good Clinical Practices, and pharmacovigilance guidelines, acting as a key representative for regulatory discussions.

Required Skills & Qualifications:

  • M.D. or equivalent degree.
  • Strong background in drug development, particularly in biologics within Oncology.
  • Proven leadership, decision-making, and communication skills, with the ability to work in a cross-functional team.
  • Expertise in the clinical development process, risk management plans, and regulatory requirements for global trials.
  • Excellent organizational skills, with the ability to manage multiple priorities and meet tight deadlines.