Associate Medical / Medical Director - Cardiovascular
Edgewise Therapeutics · United States · 3 wk ago
RemoteRemoteScience$240k–$325k/yrFull-time
About the role
Edgewise is advancing novel, muscle-targeted therapeutics for serious cardiovascular and cardiometabolic conditions with significant unmet need. We’re building a passionate, experienced team committed to tackling complex scientific and clinical challenges and delivering meaningful outcomes for patients.
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 prepare 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.
Requirements
- MD or MD/PhD with clinical trial experience required.
- Minimum of 2 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.
Pay
Salary range: $240,000 - $325,000, title and salary commensurate with experience.