Executive Director, Clinical Program Lead

About the role

We're seeking an Executive Director, Clinical Program Lead (CPL) to lead the clinical development of a respiratory asset from late Phase 2 to Phase 3b. Reporting to the Clinical Therapeutic Area Head, Respiratory, this role is a core member of the Global Project Team (GPT) and leads the Global Clinical Team.

Responsibilities

• Owning and maintaining the global Clinical Development Plan (CDP) aligned to the Target Product Profile (TPP) and portfolio strategy.
• Serving as clinical lead on the cross-functional GPT, accountable for all clinical strategy and deliverables.
• Providing senior medical oversight of global studies, including benefit-risk assessment, safety signal management, and clinical input to regulatory interactions (FDA, EMA, PMDA).
• Leading the design of mid-to-late-stage clinical trials ensuring compliance with ICH-GCP, ethical standards, and global regulatory requirements.
• Building, leading, and developing a high-performing global clinical team of physicians and scientists to support current and future programs.
• Establishing and maintaining strategic relationships with key external experts, investigators, and advisors supporting the development program.

Requirements

• An MD or MD/PhD with 10+ years of clinical development experience in biotech or pharma, with late-stage program leadership across small molecules and biologics.
• 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.
• Able to influence and act decisively within matrixed environments.
• Executive-level communication and external presence.
• Able to navigate ambiguity and drive timely, high-quality decisions.
• Commitment to patient safety, data integrity, and ethical standards.

Nice to have

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

Where You’ll Work

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.

Pay Range

$306,000.00 - $417,000.00 Annual