Medical Director, Clinical Research Cardiovascular

Responsibilities:
- Serve as clinical lead, providing medical expertise for cross-functional clinical R&D teams.
- Partner with internal stakeholders to formulate and implement comprehensive clinical development plans.
- Lead protocol design, medical monitoring, and clinical trial planning/initiations/completion; author protocols and investigator brochures.
- Provide strategic and medical input for IND submissions, information requests, NDA submissions, pediatric investigation plans, and other regulatory interactions.
- Conduct product safety medical reviews in collaboration with safety experts.
- Analyze clinical trial data; author publications and present results at medical meetings.
- Build relationships with cardiovascular thought leaders and clinical investigators.
- Plan and conduct clinical advisory board meetings; present plans/results to senior leaders.
- Provide medical/scientific input with medical and future marketing implications; maintain cardiology expertise as a key medical resource.
- Attend scientific meetings and represent the company externally.

Qualifications:
- MD or MD/PhD with cardiology board certification (American Board of Internal Medicine) plus 2+ years in clinical development (biotech/pharma or clinical investigator), including industry-sponsored multi-center trials; heart failure experience and/or subspecialty training strongly preferred.
- Proven leadership and interpersonal skills; ability to motivate interdisciplinary teams.
- Deep cardiology scientific/clinical/research knowledge.
- Strong oral and written communication; ability to communicate effectively across professional levels.
- Knowledge of CDER regulations/ICH guidelines.
- Understanding of pharmaceutical safety reporting/surveillance; Microsoft Office proficiency.
- Ability to travel ~20%.

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