Director, Clinical Development
Wave Life Sciences
August 23, 2026
Remote friendly (Greater Boston)
United States
Clinical Research and Development
Description
The Director, Clinical Development provides clinical leadership for product(s) in development, including design, planning, execution, scientific integrity, and medical oversight of clinical studies across all phases and therapeutic areas (including cardiometabolic and hepatology) from early clinical development through regulatory approval. Collaborates cross-functionally (Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program Management, Preclinical Development) to ensure aligned strategy and execution. Oversees medical monitors; provides medical input to documents (e.g., IB, IMPD, DSUR, SUSAR, IND, NDA/BLA, PIP). Interprets and disseminates results (clinical study reports, publications, and conference/regulatory presentations). Contributes to overall clinical strategy and ensures regulatory compliance. Supports translational medicine efforts in assigned TA and provides SVP-level input on program design and strategic/tactical plans.
Responsibilities
- Champion product(s) under development; serve as SME
- Keep current on literature, competitive environment, and regulatory guidelines
- Oversee/manage clinical programs and trials (ICH/GCP and Wave SOPs)
- Partner with Clinical Operations to ensure compliant study execution
- Review clinical data; support study reports and publications
- Coordinate with internal departments and external vendors (e.g., CROs)
- Serve as study medical monitor (as needed); build site/HCP/KOL relationships
- Represent Wave with regulatory agencies; support budgeting/financial planning
- Provide leadership updates; develop/implement clinical trial SOPs
- Ensure global regulatory compliance; interface with Finance/Legal and others
- Analyze/present data; may mentor/manage matrix and direct reports
Experience & Qualifications
- Board-certified MD (required)
- Formal cardiometabolic and/or hepatology training (preferred)
- 5+ years industry or combined industry/academic experience
- Experience across all stages of clinical development; clinical trial management from inception to completion including study design
- Significant experience communicating/presenting complex information to senior leadership
Key Skills
- Strong cardiometabolic scientific background
- Project planning, leadership, negotiation, presentation; creative/practical problem solving
- Knowledge of FDA and ICH regulations
- Clinical medicine and clinical pharmacology (incl. biostatistics, data management, medical writing)
- Familiarity with Good Clinical Practice (GCP)
The Director, Clinical Development provides clinical leadership for product(s) in development, including design, planning, execution, scientific integrity, and medical oversight of clinical studies across all phases and therapeutic areas (including cardiometabolic and hepatology) from early clinical development through regulatory approval. Collaborates cross-functionally (Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program Management, Preclinical Development) to ensure aligned strategy and execution. Oversees medical monitors; provides medical input to documents (e.g., IB, IMPD, DSUR, SUSAR, IND, NDA/BLA, PIP). Interprets and disseminates results (clinical study reports, publications, and conference/regulatory presentations). Contributes to overall clinical strategy and ensures regulatory compliance. Supports translational medicine efforts in assigned TA and provides SVP-level input on program design and strategic/tactical plans.
Responsibilities
- Champion product(s) under development; serve as SME
- Keep current on literature, competitive environment, and regulatory guidelines
- Oversee/manage clinical programs and trials (ICH/GCP and Wave SOPs)
- Partner with Clinical Operations to ensure compliant study execution
- Review clinical data; support study reports and publications
- Coordinate with internal departments and external vendors (e.g., CROs)
- Serve as study medical monitor (as needed); build site/HCP/KOL relationships
- Represent Wave with regulatory agencies; support budgeting/financial planning
- Provide leadership updates; develop/implement clinical trial SOPs
- Ensure global regulatory compliance; interface with Finance/Legal and others
- Analyze/present data; may mentor/manage matrix and direct reports
Experience & Qualifications
- Board-certified MD (required)
- Formal cardiometabolic and/or hepatology training (preferred)
- 5+ years industry or combined industry/academic experience
- Experience across all stages of clinical development; clinical trial management from inception to completion including study design
- Significant experience communicating/presenting complex information to senior leadership
Key Skills
- Strong cardiometabolic scientific background
- Project planning, leadership, negotiation, presentation; creative/practical problem solving
- Knowledge of FDA and ICH regulations
- Clinical medicine and clinical pharmacology (incl. biostatistics, data management, medical writing)
- Familiarity with Good Clinical Practice (GCP)