Associate Medical Director / Medical Director - Clinical Development

Edgewise Therapeutics

17d•$240,000 - $325,000

About The Position

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders. We’re building a passionate, experienced team committed to tackling complex challenges and delivering meaningful outcomes for patients. If you’re looking to do work that matters, we’d love to hear from you. The Associate Director / Director of Clinical Development will play a pivotal role in advancing our cardiovascular clinical programs. As a strategic partner to the Clinical Development team, this individual will contribute to shaping strategy, driving operational excellence, and ensuring consistent implementation across clinical initiatives.

Requirements

MD or MD/PhD with clinical trial experience required.
Minimum of 3 years in drug development within industry or equivalent biomedical research experience in academia.
Proven success in leading clinical studies and protocol development.
Strong record of scientific scholarship and achievement.
Demonstrated expertise in clinical medicine and a solid foundation in biomedical research.
Excellent interpersonal skills and ability to thrive in a collaborative, team-oriented environment.
Exceptional verbal, written, and presentation skills.
Willingness to travel up to 20% for clinical research oversight and related business needs.

Responsibilities

Contribute to the clinical development strategy for hypertrophic cardiomyopathy (HCM) and heart failure with preserved ejection fraction (HFpEF), with a focus on operational excellence and innovation.
Partner closely with Clinical Operations to support trial execution, including medical communications with clinical investigators.
Engage with trial sites and investigators to support patient enrollment and retention in Phase 2 and Phase 3 cardiovascular studies.
Support managing advisory boards with the Scientific Advisory Committee and meetings with Data Monitoring Committees (DMCs) for assigned programs.
Analyze and summarize clinical data to inform decisions on safety, efficacy, regulatory filings, study reports, and publications.
Draft clinical sections of regulatory submissions (e.g., INDs, briefing documents, BLAs) and preparing for FDA/EMA meetings.
Work closely with regulatory colleagues on regulatory documents and responses to questions from FDA/EMA.
Contribute to the development and refinement of Phase 2 HFpEF and Phase 3 HCM protocols.
Serve as medical monitor to help ensure participant safety throughout clinical trials.
Represent the company in external forums, including scientific and medical conferences, as needed.
Provide clinical insights to the commercial team by reviewing market research questions and supporting ongoing initiatives.
Adhere to all workplace health and safety policies, safe work practices, and company procedures.
Perform additional responsibilities as assigned by the supervisor.