Medical Director, Clinical Development

Socket.dev; Cambridge (MA); On-site; USD 272,000 - 302,000; Full time

Job summary

Prime Medicine is seeking a physician-scientist to drive gene therapy programs from pre-clinical to clinic in Cambridge, MA. The Medical Director will coordinate with research, regulatory, and clinical operations to implement strategies across therapeutic areas and interact with regulators.

The role involves developing trial strategies, authoring protocols (Phase I–IV), serving as medical monitor, representing development on cross-functional teams, organizing advisory boards, supporting

Qualifications

• MD or equivalent degree, preferably MD-PhD.
• Minimum 3+ years industry or equivalent experience overseeing clinical trials or related research.
• Track record of scientific and medical excellence.
• Rigorous understanding of gene therapy, genetics and immunology.
• GCP familiarity and ability to work in a matrixed environment.
• Strong written and verbal communication skills.

Responsibilities

• Develop a clinical trials strategy for efficient, safe human studies.
• Draft and author protocols for phase I–IV trials.
• Serve as medical monitor, overseeing patient safety and data analysis.
• Represent clinical development on cross-functional program teams.
• Organize Scientific Advisory Boards and engage with key opinion leaders.
• Support regulatory interactions in document preparation and discussions.
• Collaborate on translational biomarker programs and data analysis.
• Attend conferences to present data and stay updated.
• Travel up to 25% as required.

Skills

Medical knowledge

Clinical trial oversight

Communication skills

Statistical analysis

Education

MD/MD-PhD

Tools

Statistical software

Job description

Company Overview:

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).

U.S. Pay Range

$272,000 — $302,000 USD

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.

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.