Medical Director [Cardiology - Heart Failure]

EPM Scientific; California; Presencial; USD 300 000 - 520 000; Tempo integral

Resumo da oferta

EPM Scientific is seeking a Medical Director to lead Clinical Development & Medical Affairs in cardiovascular programs. MD with clinical practice and a proven medical leadership track record are required, with the ability to influence cross‑functional teams and regulatory strategies.

The role will shape the heart failure clinical development plan, guide evidence generation, oversee safety and compliance, and represent the program with external partners and regulators.

Qualificações

• MD required with clinical practice preferred (cardiologist/critical care/nephrology).
• Additional PhD/MPH/MBA highly valued.
• Deep Heart Failure expertise and leadership experience.
• Proven ability to lead medical strategy and cross-functional teams.

Responsabilidades

• Lead clinical development strategy for the heart failure portfolio.
• Oversee safety, regulatory submissions, and translational medicine activities.
• Drive evidence generation and cross-functional collaboration with Medical Affairs.
• Represent the program in external/regulatory engagements.

Conhecimentos

Heart Failure expertise

Medical leadership

Real-World Evidence

Regulatory strategy

Executive presence

Formação académica

MD degree

PhD/MPH/MBA-valued

Descrição da oferta de emprego

Location: Bedford, MA or Westlake Village, CA

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