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Executive Director, Cardiovascular Clinical Development (EDG-2025068)
Remote, United States
Executive Director, Cardiovascular Clinical Development
About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:
The Executive Director of Cardiovascular Clinical Development will serve as a senior leader within the Clinical Development organization, responsible for shaping and executing the strategic direction of cardiovascular programs, including hypertrophic cardiomyopathy (HCM) and heart failure with preserved ejection fraction (HFpEF). This role will provide high-level medical and scientific leadership across early and late-stage development, regulatory strategy, and external engagement, while partnering closely with the SVP of Clinical Development and cross-functional teams. This individual will be recognized for driving successful global clinical programs, leading regulatory submissions, and building high-performing teams that deliver innovative therapies to patients.
Essential Job Duties and Functions:
Strategic Leadership
- 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.
Medical Oversight & Scientific Leadership
- 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.
Cross-Functional Collaboration
- 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.
External Engagement
- 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.
Organizational Impact
- 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.
Required Education, Experience and Skills:
The successful candidate will combine their expertise in cardiovascular clinical development with an innovative mindset to help the Company accelerate and expand their pipeline.
In terms of the performance and personal competencies required for the position, we would highlight:
- 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.
Leadership Competencies:
- 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.
Salary range: $300,000 - $375,000, title and salary commensurate with experience
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.
There is no deadline because the employer accepts applications on an ongoing basis.
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