Medical Director, Clinical Development

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 is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com .

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

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).

Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.

Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.

U.S. Pay Range

$272,000 - $302,000 USD

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.