Note: The job is a remote job and is open to candidates in USA. Edgewise Therapeutics is dedicated to discovering new medicines that improve the lives of patients with serious muscle diseases. The Executive Director of Cardiovascular Clinical Development will lead the strategic direction of cardiovascular programs, ensuring successful execution of clinical trials and regulatory submissions while building high-performing teams to deliver innovative therapies.
Responsibilities
- Lead the design and execution of clinical development strategies for cardiovascular programs, ensuring alignment with corporate objectives and regulatory expectations
- Spearhead the transition of cardiovascular assets from early development through pivotal trials, resulting in successful IND and BLA submissions
- Drive portfolio strategy and prioritization, contributing to long-term pipeline growth and value creation
- Serve as sponsor medical monitor for cardiovascular trials, ensuring participant safety and scientific integrity
- Lead clinical data interpretation and communication to support key milestones, including regulatory filings, publications, and investor presentations
- Author and oversee clinical sections of regulatory documents, including INDs, briefing packages, and BLA/MAA submissions
- Build and lead cross-functional teams across Clinical Operations, Regulatory Affairs, Biometrics, and Medical Affairs to ensure seamless execution of clinical programs
- Partner with Business Development to evaluate external opportunities, contributing to successful licensing and acquisition deals
- Establish and maintain relationships with global key opinion leaders, academic collaborators, and clinical investigators
- Represent Edgewise at major scientific and regulatory forums, including FDA/EMA meetings, advisory boards, and international conferences
- Lead the formation and engagement of Scientific Advisory Committees to guide program strategy
- Recruit, mentor, and develop clinical development talent, fostering a culture of innovation, accountability, and scientific excellence
- Implement best practices and operational standards that improve clinical trial efficiency and data quality
- Serve as a trusted advisor to the Executive Leadership Team on cardiovascular strategy, innovation, and risk mitigation
Skills
- MD or MD/PhD
- Board Certified or Eligible in Internal Medicine
- Minimum 7 years of experience in clinical development within biopharmaceutical industry, including leadership of global cardiovascular programs
- Demonstrated success in leading clinical programs resulting in regulatory approvals or breakthrough therapy designations
- Proven track record of building and leading high-performing clinical teams
- Experience in leading regulatory interactions with FDA, EMA, and other global health authorities
- Strong publication record and recognized thought leadership in cardiovascular medicine
- Builds a high level of trust and partnership with the Executive Leadership Team
- Exceptional communication, leadership, and strategic thinking skills
- Willingness to travel up to 20% for business needs
- Subspecialty training in Cardiovascular Medicine and/or genetic cardiomyopathies preferred
Benefits
- Health benefits
- A discretionary bonus plan
- Stock option grants
- A stock purchase plan
- A 401(k) with match
- Paid time off
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