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Senior Director, Clinical Development

Senior Director, Clinical Development

New Jersey StaffingBound Brook, NJ, US
5 days ago
Job type
  • Full-time
Job description

Clinical Indication Lead

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.

The role as a Clinical Indication Lead will be responsible for the clinical input into the broader TPIP program strategy related to the pulmonary arterial hypertension indication in mid-to-late-stage development. In addition, this role will be responsible for developing clinical strategic direction of engagements with health authorities related to the registration program and anticipated filings in collaboration with the Clinical Program Lead for TPIP. The individual will articulate the clinical goals (based on the Global TPP), clinical and safety strategy, and the underlying science and clinical need to internal and external audiences with clarity and credibility.

What You'll Do :

  • Leads clinical development team responsible for mid-to-late-stage development of TPIP in the PAH indication.
  • Leads the matrix Clinical Study Team (CST) to effectively make decisions and handle conflict and change.
  • Responsible for maintaining a high degree of CST effectiveness through collaboration, influence, and, as necessary, coaching of cross-functional team members.
  • Collaborates with the Clinical Program Lead (CPL) to represent to the matrix Global Asset Team to ensure clinical program is represented and integrated into Global plans across functions.
  • Collaborates with the CPL to build strategic and coordinated clinical development plans which are aligned with business objectives (TPP) and are differentiated from competitor products.
  • Responsible for all clinical aspects of the clinical indication strategy.
  • Accountable for the delivery of projects, partnering with other global development and related functions.

Who You Are :

  • MD / DO equivalent with preference for Cardiology or Pulmonary formal training. Will consider industry experiences in Pulmonary or Cardiology in drug development.
  • 6+ years in biotech or pharma with most in a global clinical development role OR equivalent research experience. Combination of drug / device experience is a plus.
  • sNDA or sBLA experience or original NDA or BLA experience preferred. Experience with J-NDA is a plus.
  • Prefer experience in FDA advisory committee, or CHMP Scientific Advisory Group, or CHMP Oral Explanation.
  • Previous direct people management required.
  • Experience working in matrix development teams, e.g. Global Study Teams, required.

    • 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. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation.

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    Director Development • Bound Brook, NJ, US