Executive Director, Clinical Program Lead

About the role

We're looking for an Executive Director, Clinical Program Lead (CPL) to help us expand what's possible for patients with serious diseases. Reporting to the Clinical Therapeutic Area Head, Respiratory, the Executive Director, CPL will provide clinical leadership for a respiratory asset across late Phase 2 and Phase 3b development. This role is a core member of the Global Project Team (GPT) and leads the Global Clinical Team, overseeing physicians and clinical scientists responsible for study design, execution, safety oversight, and supporting regulatory engagements.

Responsibilities

• Serve as clinical lead on the cross-functional GPT, accountable for all clinical strategy and deliverables.
• Provide senior medical oversight of global studies, including benefit-risk assessment, safety signal management, and clinical input to regulatory interactions (FDA, EMA, PMDA).
• Lead the design of mid-to-late-stage clinical trials ensuring compliance with ICH-GCP, ethical standards, and global regulatory requirements.
• Build, lead, and develop a high-performing global clinical team of physicians and scientists to support current and future programs.
• Establish and maintain strategic relationships with key external experts, investigators, and advisors supporting the development program.

Requirements

• Demonstrated leadership of global Phase 2–3b programs, including clinical strategy, execution, and data interpretation.
• Strong knowledge of global regulatory pathways and interactions (FDA, EMA, PMDA).
• Proven ability to lead and influence in complex, matrixed, cross-functional organizations.
• Exceptional written and verbal communication skills with scientific, regulatory, and executive stakeholders.
• Strategic clinical judgment and scientific rigor.
• Ability to influence and act decisively within matrixed environments.
• Executive-level communication and external presence.
• Ability to navigate ambiguity and drive timely, high-quality decisions.
• Commitment to patient safety, data integrity, and ethical standards.

Qualifications

• MD or MD/PhD degree.
• 10+ years of clinical development experience in biotech or pharma, with late-stage program leadership across small molecules and biologics.

Skills

• Board certification in Pulmonary or Allergy (preferred).
• Combination drug-device experience focusing on respiratory diseases (preferred).

Benefits

See details in the Job Details section.

Pay

$306,000.00 - $417,000.00 Annual

Schedule

This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.

Contact

To apply, visit Insmed’s website.