Insmed

Senior Director, Clinical Development

Insmed$273K — $372K *
US-AnywhereRemote in New Jersey, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • MD, MD/PhD, or equivalent medical training required.
  • Board certification in an internal medicine specialty involving immunological disorders.
  • At least 7 years of clinical development experience in biotech or pharmaceutical settings.
  • Experience with drug development across various modalities including small molecules and biologics, with a preference for experience in combination products.
  • Strong understanding of global regulatory pathways (FDA, EMA, PMDA) and original NDA/MAA experience is advantageous.

Responsibilities

  • Provide clinical input to the assessment of external molecules for acquisition opportunities.
  • Contribute clinical insights to planning for molecules emerging from discovery platforms.
  • Serve on transition teams for in-licensed or acquired molecules as necessary.
  • Monitor benefit-risk profiles and manage safety signals for transitioning assets.
  • Collaborate on designing clinical studies and Clinical Development Plans to meet regulatory standards.
  • Maintain relationships with external medical experts on development programs.
  • Stay informed on emerging science and evolving standards of care related to relevant disease areas.

Benefits

  • Comprehensive medical, dental, and vision coverage plus mental health support.
  • Generous paid time off policies and family-forming benefits.
  • 401(k) plan with competitive company match and equity award opportunities.
  • Access to Company Learning Institute for professional development and networking.
  • Flexible work schedules with opportunities for meaningful in-person collaboration.
Full Job Description
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 earl 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


Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements

This role requires occasional domestic/international travel (approximately 10%)

#LI-TB1

#LI-Remote

Pay Range:
$273,000.00-372,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:
  • Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
  • Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
  • 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
  • Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
  • Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back


Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

About Insmed

Insmed is a biopharmaceutical company that develops drugs to treat serious and rare diseases. The company's lead product candidate is ARIKAYCE, which is being developed to treat patients with nontuberculous mycobacterial lung disease. Insmed is also developing drugs to treat other respiratory diseases, as well as rare diseases such as lipodystrophy. The company was founded in 1988 and is headquartered in Bridgewater, New Jersey.
Learn more about Insmed
Size
613 employees
Market Cap
$2.6 billion
Industry
Net Income
-$294 million
Revenue
$164.4 million
NASDAQ

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