Senior Director / Clinical Lead (Study Physician) Cardio; Biotech

Senior Director / Clinical Lead (Study Physician) Cardio; Biotech | Clinical-Stage Cardiovascular Biotechnology Company

About the Company:

Our client is a well-funded, clinical-stage biotechnology company focused on developing innovative therapies for serious cardiovascular diseases with significant unmet medical needs. The organization is advancing novel therapeutic approaches designed to improve outcomes for high-risk patient populations through cutting-edge science and rigorous clinical development.

The company combines deep scientific expertise with an entrepreneurial biotech culture where individuals have the opportunity to make a meaningful impact across clinical strategy, development, and execution.

Position Overview:

Our client is seeking an experienced and highly motivated Senior Director / Clinical Lead (Study Physician) to provide clinical leadership for ongoing and planned cardiovascular clinical development programs.

This individual will play a critical role in the design, execution, monitoring, and interpretation of clinical trials, with immediate focus on a later-stage cardiovascular program. The successful candidate will serve as a key medical and scientific leader across cross-functional study teams and will work closely with Clinical Operations, Biostatistics, Regulatory, Safety, Translational Medicine, and external investigators.

This role is ideal for a hands-on clinical development professional who thrives in a fast-paced biotech environment and enjoys operating at the intersection of strategy, execution, and scientific innovation.

Key Responsibilities:

• Serve as the clinical lead and study physician for ongoing and planned cardiovascular clinical trials
• Provide medical oversight and leadership for study conduct, patient eligibility review, protocol deviations, safety monitoring, and data review
• Lead development and review of clinical protocols, protocol amendments, investigator brochures, clinical study reports, and related study documents
• Partner cross-functionally with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Translational teams to drive successful study execution
• Monitor aggregate safety and efficacy data and contribute to ongoing interpretation of clinical findings
• Collaborate with investigators and study sites to support enrollment, protocol adherence, and high-quality study conduct
• Participate in dose selection discussions, endpoint strategy, and broader clinical development planning
• Contribute to regulatory submissions and interactions, including briefing materials and responses to health authority questions
• Support publication strategy, scientific presentations, and external expert engagement
• Drive cross-functional alignment and facilitate efficient decision-making within study teams
• Maintain deep understanding of the competitive landscape and evolving cardiovascular clinical development trends

Qualifications

Required:

• MD or PharmD required
• Minimum 5+ years of sponsor-side clinical development experience within biotech or pharmaceutical industry
• Prior experience serving as a Clinical Lead, Study Physician, Medical Monitor, or similar clinical development role
• Experience supporting Phase 1–3 clinical trials
• Strong clinical judgment and ability to apply scientific knowledge to real-world study execution challenges
• Experience interpreting clinical and safety data
• Demonstrated ability to work cross-functionally within matrixed development organizations
• Excellent written and verbal communication skills
• Ability to operate effectively in a fast-moving biotech environment

Preferred

• Cardiovascular clinical development experience strongly preferred
• Experience in hypertension, heart failure, cardiometabolic disease, renal disease, or vascular medicine highly desirable
• Experience interacting with investigators and clinical trial sites
• Experience with INDs, regulatory submissions, and FDA interactions
• Prior experience in small or mid-sized biotech companies
• Experience with novel therapeutic modalities including oligonucleotide or genetic medicine platforms is a plus

What Makes This Opportunity Unique:

• Opportunity to help lead development in an underserved and highly impactful cardiovascular disease setting
• Opportunity to work on a novel therapeutic platform with significant scientific and clinical potential
• Direct influence on clinical strategy and study execution within a growing biotechnology company
• Highly collaborative culture with experienced leadership and development teams
• Opportunity to contribute meaningfully to programs designed to improve outcomes for severely ill cardiovascular patients

Ideal Candidate Profile:

The ideal candidate is:

• scientifically rigorous,
• operationally strong,
• decisive,
• collaborative,
• and comfortable working hands-on within clinical trial execution.

This is a highly visible role for someone who enjoys being close to the science, the data, and the day-to-day realities of running impactful clinical studies.

Employment Type:

Our client is open to considering:

• Full-time permanent candidates
• Contract-to-hire candidates

Contact:

Recruiting Team

sspinelli@cornerstonesg.com – P 973-656-0220

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