Director Clinical Development - Cardiovascular

CSG Talent

Cambridge, MA 02140, USA

Published: 6/14/2022

Healthcare

Full Time

Job Description

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.