Executive Director/Vice President - Therapy Area Head- Cardiorenal

Position Summary
- Lead clinical development strategy for heart failure and fluid overload (Cardiorenal) and company products addressing this condition, including development-stage and postmarketing clinical programs and medical strategy for scientific exchange.
- Provide strategic leadership across Translational Medicine, Clinical Development, Clinical Operations, Biostatistics/Data Management, Medical Affairs, Drug Safety/Pharmacovigilance, and Regulatory Affairs.

Responsibilities
- Advance Cardiorenal clinical programs and integrate parenteral and pulmonary delivery strategies where relevant.
- Act as senior clinical authority for Cardiorenal drug development across executive and governance forums.
- Synthesize scientific, clinical, regulatory, and competitive insights to prioritize pipeline and shape evidence/lifecycle planning.
- Partner with CMO to lead heart failure clinical development strategy.
- Lead Phase 1–4 clinical trial design and planning (dose selection, patient segmentation, biomarkers, endpoints).
- Oversee advisory board strategy; ensure protocols meet scientific integrity, operational feasibility, and regulatory alignment.
- Oversee Cardiorenal clinical program execution; partner on data integrity/statistics.
- Define safety/pharmacovigilance strategy; interpret safety signals and ensure risk-benefit assessments.
- Guide translational medicine/clinical pharmacology (biomarkers, PK/PD, mechanistic endpoints).
- Ensure GCP/ethics/inspection readiness; accountable for medical monitoring.
- Lead regulatory strategy and submissions (INDs, NDAs/BLAs, CSRs, responses).
- Oversee development of key scientific/regulatory documents.
- Provide Medical Affairs content leadership; support publication planning.
- Analyze and communicate clinical data; provide strategic recommendations to executives.
- Partner with Commercial/Market Access/Business Development and support BD diligence; manage Cardiorenal TA medical/scientific resourcing and budget.
- Mentor colleagues and drive workforce/talent development and succession planning.

Qualifications
- Education: M.D. required; cardiology/critical care/nephrology preferred. PhD/MPH/MBA valued.
- Experience: 10+ (15+) years in medical affairs and/or clinical development in pharma/biotech.
- Strong cardiovascular expertise; congestive heart failure preferred.
- Track record designing/executing cardiovascular chronic disease trials; wearable-device experience preferred.
- Proven cross-functional leadership and global regulatory interaction experience.
- Exceptional scientific communication and analytical/leadership skills.
- Ability/willingness to travel ~20% (primarily domestic).

Industry Knowledge (required)
- Clinical development methodologies (biomarkers, PK/PD, translational approaches) and regulatory pathways for cardiorenal diseases.
- Knowledge of U.S. and ex-U.S. regulatory/clinical research requirements for cardiovascular drug development.
- Ability to integrate scientific, regulatory, competitive, and operational considerations into development strategy.