Medical Director [Cardiology - Heart Failure]

Location: Bedford, MA or Westlake Village, CA

Salary: $240K-$325K

Title: Medical Director [Clinical Development & Med Affs]

Position Overview

The ideal candidate will combine strong clinical credentials with strategic leadership experience and a proven track record of driving impact in a cardiovascular-focused organization. Please prioritize candidates who have held significant medical leadership responsibility and can demonstrate both scientific depth and business acumen.

Key Responsibilities

Therapeutic Area Leadership & Strategy

• Advance clinical programs across Cardiorenal disorders, and associated chronic disease pathways, integrating parenteral and pulmonary drug delivery strategies where relevant.
• Support the CMO to lead the clinical development strategy for the heart failure portfolio, ensuring alignment with MannKind's scientific platforms, inhaled‑therapeutic technologies, and long‑term enterprise objectives.

Clinical Study Planning & Design

• Lead the design and planning of Phase 1-4 clinical trials across cardiorenal and related chronic disease indications, including dose selection, patient segmentation, biomarker strategy, and endpoint development.
• Engage internal scientific leaders and external experts across cardiology, nephrology, critical care, and related specialties to refine study rationale, strengthen mechanistic understanding, and optimize development pathways.

Clinical Study Execution & Oversight

• Oversee the execution of all Cardiorenal clinical programs, directing cross‑functional interfaces to ensure robust, efficient, and high‑quality delivery of evidence across early‑ and late‑stage development.
• Biostatistics & Data Management - Partner closely to ensure data integrity, statistical rigor, and high‑quality analyses that support regulatory submissions and scientific decision‑making.
• Safety / Pharmacovigilance - Define safety strategy, oversee safety surveillance, interpret emerging safety signals, and ensure comprehensive risk‑benefit assessments throughout development.
• Translational Medicine & Clinical Pharmacology - Guide biomarker strategy, PK/PD modeling, and mechanistic endpoint selection to strengthen scientific understanding and accelerate development.
• Clinical Operations - Provide input into CRO and vendor oversight, operational planning, site engagement, and execution of global clinical studies.
• Ensure all studies adhere to FDA, EMA, and global regulatory requirements, including GCP, ethical standards, and inspection readiness.
• Maintain accountability for medical monitoring, serving directly as the medical monitor or by providing leadership and oversight to delegated medical monitors.

Regulatory Leadership & Scientific Communication

• Support regulatory strategy and submission development for the Cardiorenal portfolio, including INDs, NDAs/BLAs, briefing documents, clinical study reports, and responses to regulatory agencies.
• Represent the therapeutic area in FDA, EMA, and global regulatory interactions, ensuring teams are fully prepared for meetings, advisory committees, inspections, and cross‑agency engagements.

Medical Affairs Collaboration

• Provide content support to Medical Affairs to shape scientific platforms, disease‑area lexicons, and evidence strategies across cardiorenal conditions.
• Ensure alignment between clinical development strategy and field‑based medical strategy, driving consistent non-promotional scientific messaging across medical/clinical and payor audiences.
• Support publication planning and scientific communication, ensuring clarity, accuracy, and cohesion across the evolving evidence base.

Requirements:

• M.D. required, with clinical experience in medical practice preferred, ideally as a cardiologist, critical care physician, or nephrologist. An additional PhD, MPH, or MBA also highly valued.
• Deep expertise in Heart Failure
• Strong background in Real-World Evidence (RWE), including the ability to generate, interpret, and apply evidence to support clinical and business strategy
• Demonstrated experience as a Medical Director (or equivalent leadership role) with a clear understanding of what "good" looks like from both a scientific and strategic perspective
• Ability to provide medical leadership across clinical development, medical affairs, external engagement, and evidence generation activities
• Executive presence with the ability to influence cross-functional stakeholders and serve as a credible scientific leader both internally and externally

If you're interested, please drop a CV and we'll be in touch if it's a good fit.