Insmed

Senior Director, Clinical Research & 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, PharmD or equivalent medical training required
  • At least 7 years of clinical development experience in biotech or pharmaceutical settings
  • Experience with oral small molecules and biologics; combination drug-device experience preferred
  • Original NDA, MAA, and J-NDA experience is essential
  • In-depth understanding of global regulatory pathways, including FDA, EMA, and PMDA

Responsibilities

  • Provide clinical evaluation of external molecules during Due Diligence
  • Contribute to cross-functional planning for molecules from discovery platforms
  • Participate in transition teams for in-licensed or acquired molecules
  • Oversee clinical execution and development planning
  • Maintain awareness of scientific developments and competitive landscapes

Benefits

  • Comprehensive medical, dental, and vision coverage
  • Generous paid time off policies with family-forming benefits
  • 401(k) plan with competitive company match
  • Access to a Company Learning Institute for professional growth
  • Employee resource groups and volunteer opportunities
Full Job Description
About the Role:
We're looking for a Senior Director, Clinical Research & Development on the Clinical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Vice President, Disease Area Head, Respiratory, 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.

The disease areas supported may be guided, in part, by the physician's clinical expertise. However, there is an expectation that the physician will possess sufficient breadth of experience to contribute meaningfully to initial evaluations across multiple disease areas, leveraging external medical experts as needed.
This is a remote role.

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.
  • Have oversight of clinical execution, along with management of clinical development planning and external engagement.
  • Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas.


Who You Are:

You have an MD, MD/PhD, PharmD or equivalent medical training, with board certification in an internal medicine specialty preferred 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.

You are or you also have:
  • Original NDA, MAA, and J-NDA experience.
  • 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.
  • 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.


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 (up to 20%).

#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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