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Vice President, Clinical Development

1 day, 20 hours ago
United States
Full-time
Executive
Consultant
Operations
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 132

Description

  • Report to the Chief Medical Officer and provide medical and strategic support across Precision for Medicine.
  • Support global business development activities, including client engagement, proposal support, capability meetings, and professional meetings.
  • Provide strategic drug development consulting to autoimmune, rare, and orphan disease clients.
  • Develop integrated medical, clinical, regulatory, biostatistical, translational, and marketing strategies for client programs.
  • Create, review, and revise protocols, case report forms, training materials, project tools, analysis plans, study designs, clinical trial reports, and IND submissions.
  • Review laboratory values, adverse events, coding dictionaries, and data tables, listings, and figures as needed.
  • Participate in and drive feasibility discussions for project proposals.
  • Develop training modules and deliver training for project teams and colleagues.
  • Ensure deliverables meet high standards of medical, ethical, and scientific integrity.
  • Propose strategies to manage and accelerate drug development timelines and support client satisfaction.

Requirements

  • MD, MBBS, or equivalent medical training, plus fellowship training in Endocrinology, Rheumatology, Hematology-Oncology, or a related field.
  • Board certification preferred, including European equivalents.
  • Experience in direct interactions with US and/or EU Regulatory Authorities.
  • At least 10 years of senior leadership experience in the clinical research industry.
  • Substantial experience across related disciplines such as operations, medical monitoring, biostatistics, regulatory, preclinical, and translational pharmacology.
  • Recent health authority experience preferred, such as current or former FDA medical reviewer experience.
  • Clinical experience with regulatory and statistical document preparation and review, including protocols, SAPs, IND, NDA, PSUR, DSUR, IB, ICF, breakthrough designation, and regulatory briefing documents.
  • Working knowledge of global safety reporting processes.
  • Ability to travel domestically and internationally for client meetings, health authority meetings, and conferences.

Benefits

  • Base salary range of $254,900 to $382,300 USD.
  • Eligible for a discretionary annual bonus.
  • Health insurance benefits.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.
  • Remote work environment (#LI-Remote).

Interested in this position?

Apply directly on the company website

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