Senior Director, Clinical Development

Senior Director, Clinical Development

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:

We're looking for a Senior Director, Clinical Development on the Clinical Development team to help us expand what's possible for patients with serious diseases. You'll serve as a clinical leader responsible for supporting two primary activities. First, the role provides clinical evaluation of potential in-licensing or acquisition opportunities coordinated and led by Insmed's Business Development organization. Second, the role supports cross-functional discussions with Insmed discovery research platforms as molecules advance beyond the Late Lead Optimization milestone that may have potential development in immunological disorders apart from respiratory diseases and as cush there is an expectation that the physician will possess sufficient breadth of experience to contribute meaningfully to initial evaluations across multiple immunological disorders;

leveraging external medical experts as needed.

What You'll Do:

In this role, you'll have the opportunity to provide clinical input into the overall assessment of external molecules as a member of Due Diligence teams. You'll also:

• Contribute clinical input to cross-functional planning for molecules emerging from Insmed discovery platforms at the Late Lead Optimization stage.
• Serve, as needed, on transition teams for molecules that are in-licensed, acquired, or partnered.
• Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas.
• Partner with Global Clinical Development functions to monitor benefit–risk profiles, manage safety signals, and support regulatory communications or meetings for any ongoing studies associated with in-licensed or acquired assets that are in transition to early GPT or GPT formation.
• Collaborate with Global Clinical Development functions to support the design of potential clinical studies and Clinical Development Plans (CDPs) that meet global ICH-GCP, ethical, and regulatory standards.
• Build and maintain strong partnerships with external medical experts supporting development programs for in-licensed or acquired assets that are in transition to early GPT or GPT formation, as well as emerging programs from Insmed discovery platforms.

Who You Are:

You have an MD, MD/PhD, or equivalent medical training is required, with board certification in an internal medicine specialty that includes immunological disorders such as Rheumatology or Transplantation. Drug development experiences will be considered as relevant, along with at least 7 years of clinical development experience in biotech or pharmaceutical settings, with meaningful drug development experience across modalities, including oral small molecules and biologics;

experience with combination drug–device products preferred. Original NDA, MAA, and J-NDA experience is a plus. You are or also have:

• Demonstrated leadership in the design, execution, and interpretation of global Phase 1–2a clinical programs; experience with combination drug–device development and later-stage programs is a plus.
• Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• Proven ability to lead and influence effectively within cross-functional, matrixed organizations.
• Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.
• Strategic thinking and sound clinical judgment
• High scientific and analytical rigor
• Strong influence and decision-making skills in matrixed environments
• Excellence in communication and external engagement
• Ability to navigate ambiguity and make timely, balanced decisions
• Effective collaboration across global, cross-functional teams

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