Medical Director - Gene Therapy Clinical Programs

Prime-Medicine; Cambridge (MA); On-site; USD 272,000 - 302,000; Full time

Benefits offered by this job

Equity programs

401(k) match

Annual incentive plan

Paid time off

Job summary

Prime Medicine in Cambridge, MA is seeking a physician-scientist to lead programs from pre-clinical development into the clinic. The medical director will collaborate across research, regulatory affairs, clinical operations and trials teams to implement Prime’s strategies across therapeutic areas.

The role includes designing and executing clinical trials, serving as medical monitor, engaging with sites and regulators, presenting data at conferences, and travel up to 25%.

Qualifications

• MD or equivalent degree, preferably MD-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.
• Basic understanding of Good Clinical Practice.
• Ability to work in a heavily matrixed, cross-functional environment.

Responsibilities

• 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.
• 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%.

Skills

Clinical trials

Medical writing

Regulatory knowledge

Biostatistics

Gene therapy

Education

MD/MD-PhD

Tools

Biostatistics tools

Job description

Prime Medicine in Cambridge, MA is seeking a physician-scientist to lead programs from pre-clinical development into the clinic. The medical director will collaborate across research, regulatory affairs, clinical operations and trials teams to implement Prime’s strategies across therapeutic areas.

The role includes designing and executing clinical trials, serving as medical monitor, engaging with sites and regulators, presenting data at conferences, and travel up to 25%.