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Executive Director/ Vice President, Cardiovascular Clinical Development jobs in United States
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Edgewise Therapeutics · 3 weeks ago

Executive Director/ Vice President, Cardiovascular Clinical Development

Edgewise 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 be responsible for shaping and executing the strategic direction of cardiovascular programs, providing high-level medical and scientific leadership across early and late-stage development.
PharmaceuticalBiotechnologyHealthcareBiopharmaHealth 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

Cardiovascular Clinical DevelopmentHypertrophic Cardiomyopathy (HCM)Heart Failure with Preserved Ejection Fraction (HFpEF)Regulatory StrategyIND SubmissionBLA SubmissionClinical Trial DesignMedical MonitoringClinical Data InterpretationRegulatory Document AuthoringGlobal Clinical Program LeadershipFDA InteractionsEMA InteractionsClinical Team LeadershipScientific PublicationStrategic Thinking

Required

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

Preferred

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

Company

Edgewise Therapeutics

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Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization.

Funding

Current Stage
Public Company
Total Funding
$738.5M
Key Investors
Viking Global InvestorsNovo Holdings,U.S. Venture Partners
2025-04-02Post Ipo Equity· $200M
2024-01-19Post Ipo Equity· $240M
2022-09-13Post Ipo Equity· $138M

Leadership Team

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Kevin Koch, Ph.D.
President and CEO
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Alan Russell
Co-Founder & Chief Scientific Officer
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Company data provided by crunchbase