Executive Director, Cardiovascular Clinical Development
Edgewise Therapeutics
2 months ago
Remote friendly (United States)
United States
Clinical Research and Development
Executive Director, Cardiovascular Clinical Development
Responsibilities:
- Lead the design and execution of clinical development strategies for cardiovascular programs (HCM and HFpEF), aligned with corporate objectives and regulatory expectations.
- Transition cardiovascular assets from early development through pivotal trials, resulting in successful IND and BLA submissions.
- Drive portfolio strategy and prioritization to support 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 (regulatory filings, publications, investor presentations).
- Author and oversee clinical sections of regulatory documents (INDs, briefing packages, BLA/MAA submissions).
- Build and lead cross-functional teams across Clinical Operations, Regulatory Affairs, Biometrics, and Medical Affairs.
- Partner with Business Development to evaluate external opportunities and support licensing/acquisition deals.
- Establish and maintain relationships with key opinion leaders, academic collaborators, and clinical investigators.
- Represent the company at major scientific/regulatory forums (FDA/EMA meetings, advisory boards, international conferences).
- Lead formation and engagement of Scientific Advisory Committees.
- Recruit, mentor, and develop clinical development talent.
- Implement best practices to improve clinical trial efficiency and data quality.
- Advise Executive Leadership on cardiovascular strategy, innovation, and risk mitigation.
Qualifications (Required / Preferred):
- MD or MD/PhD; Board Certified or Eligible in Internal Medicine. Subspecialty training in Cardiovascular Medicine and/or genetic cardiomyopathies preferred.
- Minimum 7 years of biopharmaceutical clinical development experience, including leadership of global cardiovascular programs.
- Demonstrated success leading clinical programs to regulatory approvals or breakthrough therapy designations.
- Proven track record building and leading high-performing clinical teams.
- Experience leading regulatory interactions with FDA, EMA, and other global health authorities.
- Strong publication record and recognized thought leadership in cardiovascular medicine.
- Exceptional communication, leadership, and strategic thinking skills.
- Willingness to travel up to 20%.
Benefits:
- Health benefits; discretionary bonus plan; stock option grants; stock purchase plan; 401(k) with match; paid time off.
Application Instructions:
- The employer accepts applications on an ongoing basis.
Responsibilities:
- Lead the design and execution of clinical development strategies for cardiovascular programs (HCM and HFpEF), aligned with corporate objectives and regulatory expectations.
- Transition cardiovascular assets from early development through pivotal trials, resulting in successful IND and BLA submissions.
- Drive portfolio strategy and prioritization to support 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 (regulatory filings, publications, investor presentations).
- Author and oversee clinical sections of regulatory documents (INDs, briefing packages, BLA/MAA submissions).
- Build and lead cross-functional teams across Clinical Operations, Regulatory Affairs, Biometrics, and Medical Affairs.
- Partner with Business Development to evaluate external opportunities and support licensing/acquisition deals.
- Establish and maintain relationships with key opinion leaders, academic collaborators, and clinical investigators.
- Represent the company at major scientific/regulatory forums (FDA/EMA meetings, advisory boards, international conferences).
- Lead formation and engagement of Scientific Advisory Committees.
- Recruit, mentor, and develop clinical development talent.
- Implement best practices to improve clinical trial efficiency and data quality.
- Advise Executive Leadership on cardiovascular strategy, innovation, and risk mitigation.
Qualifications (Required / Preferred):
- MD or MD/PhD; Board Certified or Eligible in Internal Medicine. Subspecialty training in Cardiovascular Medicine and/or genetic cardiomyopathies preferred.
- Minimum 7 years of biopharmaceutical clinical development experience, including leadership of global cardiovascular programs.
- Demonstrated success leading clinical programs to regulatory approvals or breakthrough therapy designations.
- Proven track record building and leading high-performing clinical teams.
- Experience leading regulatory interactions with FDA, EMA, and other global health authorities.
- Strong publication record and recognized thought leadership in cardiovascular medicine.
- Exceptional communication, leadership, and strategic thinking skills.
- Willingness to travel up to 20%.
Benefits:
- Health benefits; discretionary bonus plan; stock option grants; stock purchase plan; 401(k) with match; paid time off.
Application Instructions:
- The employer accepts applications on an ongoing basis.