Edgewise Therapeutics · 3 months ago
Executive Director, Cardiovascular Clinical Development (EDG-2025068)
United States
Full-time
Remote
Director/Executive
$300K/yr - $375K/yr
7+ years expEdgewise Therapeutics is on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. The Executive Director of Cardiovascular Clinical Development will lead the strategic direction of cardiovascular programs, ensuring successful clinical development and regulatory submissions while collaborating with cross-functional teams and external stakeholders.
BiopharmaBiotechnologyHealth Care
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
Qualification
Required
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 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
Visionary Thinking: Anticipates industry trends and positions the organization for long-term success through innovative clinical strategies
Execution Excellence: Delivers results in complex environments, including successful IND/BLA submissions and global trial execution
Influence & Collaboration: Builds trust across diverse stakeholders and inspires alignment through clear, compelling communication
Innovation & Agility: Drives continuous improvement and scientific curiosity, fostering a culture of bold thinking and adaptability
Benefits
Health benefits
A discretionary bonus plan
Stock option grants
A stock purchase plan
A 401(k) with match
Paid time off
Company
Edgewise Therapeutics
Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$738.5MKey Investors
Viking Global Investors
2025-04-02Post Ipo Equity· $200M
2024-01-19Post Ipo Equity· $240M
2022-09-13Post Ipo Equity· $138M
Leadership Team
Alan Russell
Co-Founder & Chief Scientific Officer
R.Michael Carruthers
Chief Financial Officer
Recent News
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2025-12-25
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2025-12-25
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