Director Clinical Development - Cardiovascular

Medical Director - Cardiovascular

Location: Boston, MA (Hybrid or Onsite Options)

We are seeking an experienced Medical Director to provide clinical leadership for cardiovascular drug development programs spanning early- to late-phase trials. This role offers the opportunity to shape strategy, oversee study execution, and collaborate with cross-functional teams in advancing innovative therapies aimed at addressing significant unmet needs in cardiovascular medicine.

Key Responsibilities

• Serve as the medical lead for cardiovascular clinical programs, guiding development strategy from concept through regulatory submission.

• Lead the design, execution, and interpretation of clinical trials across multiple phases.

• Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Biostatistics, Drug Safety, Translational Medicine, and Commercial.

• Provide medical monitoring oversight to ensure patient safety, data integrity, and regulatory compliance.

• Represent programs to external stakeholders, including investigators, scientific advisory boards, regulatory agencies, and key opinion leaders (KOLs).

• Contribute to and review clinical protocols, investigator brochures, INDs, clinical study reports, and regulatory submissions.

• Stay informed of emerging trends, therapeutic advances, and competitive developments in cardiovascular medicine.

Qualifications

Education

• MD or MD/PhD required; board certification in cardiology or a related specialty preferred.

Experience

• 5+ years in clinical development within the biopharmaceutical industry.

• Proven track record in cardiovascular clinical research, including late-phase trial experience.

• Prior experience with global regulatory submissions (NDA/BLA/MAA) preferred.

• Strong background in clinical trial design, data interpretation, and risk-benefit analysis.

• Experience engaging with KOLs and advisory boards.

Skills

• In-depth knowledge of ICH-GCP and relevant regulatory guidelines.

• Exceptional communication skills, with the ability to influence cross-functional teams and external partners.

• Strategic mindset with a collaborative, solutions-oriented approach.

Additional Details

• Travel: ~15% (domestic and international)

• Competitive base salary and benefits package.

• This position is open to candidates in the Boston area or those willing to relocate.