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Insmed

Develops therapies for rare diseases

Senior Director - Clinical Development

Biology & BiotechUpdated on Nov 13
Full-timeRemote in USA

About the Job

Requirements

  • An MD, MD/PhD, or equivalent medical training is required.
  • Board certification in an internal medicine specialty that includes immunological disorders, such as Rheumatology or Transplantation, is required.
  • At least 7 years of clinical development experience in biotech or pharmaceutical settings is required.
  • Meaningful drug development experience across modalities, including oral small molecules and biologics, is required.
  • Demonstrated leadership in the design, execution, and interpretation of global Phase 1–2a clinical programs is required.
  • A strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA, is required.
  • The candidate must be able to lead and influence effectively within cross-functional, matrixed organizations.
  • Strong written and verbal communication skills to engage scientific, regulatory, and executive stakeholders are required.
  • Strategic thinking, sound clinical judgment, scientific and analytical rigor, influence, decision-making, communication, external engagement, and the ability to navigate ambiguity and make timely, balanced decisions are required.
  • Effective collaboration across global, cross-functional teams is required.

Responsibilities

  • Provide clinical evaluation of potential in-licensing or acquisition opportunities coordinated and led by the Business Development organization.
  • Support cross-functional discussions with discovery research platforms as molecules advance beyond the Late Lead Optimization milestone and may have potential development in immunological disorders apart from respiratory diseases.
  • Contribute clinical input to the overall assessment of external molecules as a member of Due Diligence teams.
  • Contribute clinical input to cross-functional planning for molecules emerging from 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 ongoing studies associated with in-licensed or acquired assets 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 that meet global ICH-GCP, ethical, and regulatory standards.
  • Build and maintain partnerships with external medical experts supporting development programs for in-licensed or acquired assets in transition to early GPT or GPT formation, as well as emerging programs from discovery platforms.

Desired Qualifications

  • Experience with combination drug–device products is preferred.
  • Experience with combination drug–device development and later-stage programs is a plus.
  • Original NDA, MAA, and J-NDA experience is a plus.

About the Company

Insmed

Develops therapies for rare diseases

Insmed focuses on developing and delivering therapies for serious and rare diseases. Its products come from a pipeline of clinical trials and approved treatments, sold to patients in global markets with offices in Bridgewater, NJ, Europe, and Japan. The company’s work combines research and development, regulatory approvals, and commercialization to bring therapies from discovery to patients. Insmed differentiates itself by addressing unmet medical needs in rare diseases and maintaining a global infrastructure that supports development, approval, and patient access. The goal is to improve patient outcomes by providing effective treatments for conditions with limited existing options.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bridgewater Township, New Jersey
Founded
1988

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