Associate Medical Director / Medical Director - Clinical Development at Edgewise Therapeutics in US

Job description

• At Edgewise, we are focused on advancing novel, muscle-targeted therapeutics for serious cardiovascular and cardiometabolic conditions with significant unmet need. Leveraging our expertise in muscle biology and small molecule drug development, we are building a cardiovascular pipeline that includes programs for hypertrophic cardiomyopathy, heart failure and other serious cardiovascular diseases.
• We’re building a passionate, experienced team committed to tackling complex scientific and clinical 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.

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.

Requirements

• MD 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.

Skills

Required

• MD
• Clinical trial experience
• Drug development experience
• Leading clinical studies
• Protocol development
• Scientific scholarship
• Clinical medicine expertise
• Biomedical research foundation
• Interpersonal skills
• Collaborative team-oriented
• Verbal, written, and presentation skills
• Willingness to travel up to 20%

Benefits

• Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
• Salary range: $240,000 - $325,000, title and salary commensurate with experience