Senior Medical Director, Clinical Development

The role

A physician-scientist will lead programs from pre-clinical development into the clinic. This person will develop, implement, and execute clinical trials across multiple therapeutic areas.

What you will do

• Develop a clinical trials strategy for the introduction of Prime gene editing therapeutics into human study participants.
• Conceptualize and author clinical trials protocols from phase I - IV.
• Serve as medical monitor to interface with site investigators, oversee patient safety, and analyze data.
• Represent clinical development on cross functional program teams.
• Organize Scientific Advisory Boards and solicit feedback from Key Opinion Leaders.
• Support regulatory interactions in document formulation and face-to-face discussions.
• Collaborate with pre-clinical research to implement a translational biomarkers program.
• Attend scientific and medical conferences to support data presentation or acquire information.
• Travel to investigator sites, regulatory meetings and conferences.

Required qualifications

• M.D. or equivalent degree
• Minimum 3+ years industry or equivalent academic experience 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
• Broad medical knowledge and facility with novel medical concepts
• Basic understanding of Good Clinical Practice
• Facility and comfort with standard statistical methodologies and analytical tools
• Strong communication skills with experience composing scientific publications and delivering oral presentations
• Ability to work in a heavily matrixed, cross-functional environment

Nice to have

• M.D.-PhD
• Specialization in Pulmonology or Hepatology

Benefits

• Medical
• Dental
• Vision
• Life insurance
• 401(k) match
• Equity programs
• Paid time off
• Wellness days
• Company-wide recharge breaks

About the company

Prime Medicine is a biotechnology company creating gene editing therapies using its proprietary Prime Editing platform. The company focuses on therapeutic programs in hematology, immunology & oncology, liver and lung.