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Medical Director, Clinical Development

Prime Medicine· Clinical
Apply on company site
Cambridge, MA$272k - $302kFull-timePosted 1mo ago

About the role

Physician-scientist with gene therapy background to lead Prime Medicine’s programs from pre-clinical development into the clinic, coordinating across research, regulatory affairs, clinical operations and clinical sciences to develop and execute multi-therapeutic clinical trials.

Responsibilities

  • In collaboration with research, clinical sciences, regulatory affairs and clinical operations, develop a clinical trials strategy for the efficient and safe introduction of Prime gene editing therapeutics into human study participants, through in-human proof-of-concept.
  • With support from clinical sciences and medical writing, conceptualize and author clinical trials protocols, including observational and all interventional trials from phase I - IV
  • Serve as medical monitor, responsible for interfacing with site investigators, overseeing patient safety and analyzing data from clinical trials
  • Represent clinical development on cross functional program teams
  • Organize Scientific Advisory Boards and solicit feedback from Key Opinion Leaders
  • Support Prime Medicine regulatory interactions both in the formulation of regulatory documents and in face-to-face discussions with regulators
  • Collaborate with pre-clinical research to implement a translational biomarkers program for all clinical trials, and analyze translational data from Prime Medicine’s trials.
  • Attend scientific and medical conferences as needed, to support presentation of Prime Medicine data and/or acquire state-of-the-art information in a relevant therapeutic field.
  • Travel to investigator sites, regulatory meetings and conferences will be required. Must be able to travel up to 25%.

Qualifications

  • M.D. or equivalent degree, preferably M.D.-PhD
  • Minimum 3+ years industry or equivalent academic experience, either overseeing clinical trials or performing relevant research
  • Track record of scientific and medical excellence
  • Rigorous understanding of core scientific concepts in gene therapy, genetics and immunology
  • Specialization in Pulmonology or Hepatology preferred, but not required. Broad medical knowledge and facility with novel medical concepts is required.
  • Basic understanding of Good Clinical Practice
  • Facility and comfort with standard statistical methodologies and analytical tools
  • Strong communication skills, with demonstrated experience composing scientific publications and delivering oral presentations
  • Ability to work in a heavily matrixed, cross-functional environment

Skills

Required:Clinical trial strategyClinical protocol developmentMedical monitoring
Nice to have:Regulatory affairs collaboration

Benefits

  • Total Rewards package with medical, dental, vision, life insurance; 401(k) match; equity programs; generous paid time off, wellness days, and company-wide recharge breaks
Last updated Sep 16, 2026. Interested? Apply on the company site.

About Prime Medicine

Delivering on the promise of Prime Editing

Prime Medicine™ was founded with a goal of transforming the lives of patients with debilitating diseases through the application of our groundbreaking Prime Editing platform and technology.

next- generation gene editingPrime Editinggene editingtherapeutic applications
Company profileWebsite

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