Position Summary
Therapy Area Head (TAH), Cardiorenal—medical leader responsible for the clinical development strategy for heart failure and fluid overload.
Responsibilities
- Advance cardiorenal clinical programs, integrating parenteral/pulmonary drug delivery strategies where relevant.
- Serve as senior clinical authority and represent the therapeutic area in executive/governance forums.
- Synthesize scientific, clinical, regulatory, and competitive insights to prioritize the pipeline and shape evidence/lifecycle planning.
- Partner with the CMO to lead heart failure portfolio clinical development strategy.
- Lead design/planning of Phase 1–4 trials (dose selection, patient segmentation, biomarkers, endpoints).
- Oversee advisory board strategy and ensure protocols meet scientific integrity, feasibility, and regulatory alignment.
- Oversee execution of all cardiorenal clinical programs; ensure data integrity and statistical rigor.
- Define and oversee safety/pharmacovigilance strategy and risk-benefit assessments.
- Guide translational medicine/clinical pharmacology (biomarkers, PK/PD, mechanistic endpoints).
- Lead regulatory strategy and submissions; represent the TA in FDA/EMA/global interactions.
- Partner with Medical Affairs to drive scientific platforms and non-promotional messaging.
- Provide strategic recommendations from trial learnings; partner with Commercial/Market Access/BD.
- Lead TA medical/scientific resourcing and budget planning; mentor and drive workforce/talent development.
Qualifications
- MD required; clinical experience preferred (cardiology, critical care, or nephrology). PhD/MPH/MBA valued.
- 10+ (15+) years progressive medical affairs and/or clinical development in pharma/biotech.
- Strong cardiovascular expertise; congestive heart failure strongly preferred.
- Track record designing/executing cardiovascular chronic disease trials; wearable devices preferred.
- Ability to lead cross-functional teams and represent programs in global regulatory interactions.
- Exceptional scientific communication, analytical, and leadership skills.
- Travel ~20% (primarily domestic).
- Deep knowledge of clinical development, biomarkers, PK/PD, translational medicine, and US/ex-US regulatory pathways.