Medical Director, Clinical Development

Position Overview:

We are seeking a physician-scientist with an interest and/or background in gene therapy to lead Prime Medicine’s programs from pre-clinical development into the clinic.  The medical director will serve an integral role in the clinical development organization.  They will interact broadly across the organization with research and with regulatory affairs in order to implement Prime’s strategies across one or more therapeutic areas.  In concert with the clinical operations and clinical sciences teams, they will be responsible for the development, implementation and execution of clinical trials across multiple therapeutic areas.  They will act as a representative of Prime Medicine in interactions with key opinion leaders, site investigators and regulators.  The medical director will report to clinical development leadership. 

 Key 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