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Executive Medical Director, Clinical Development

1 month ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
GCP
Apply Now
Immunovant

Immunovant

Pharmaceuticals
51-250
Founded 2018
$725M raised
View All Jobs 3

Description

  • Provide clinical scientific leadership for the clinical study team.
  • Lead medical oversight of one or more neurology development programs, including the ongoing IMVT-1402 study in CIDP.
  • Provide medical leadership across cross-functional workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
  • Oversee CRO medical monitors and safety monitoring activities.
  • Collaborate on analysis and interpretation of clinical trial safety data.
  • Lead clinical trial design, protocol development, and writing of clinical documents.
  • Write or contribute to IND, IB, CSR, DSUR, BLA, and other regulatory submissions and responses.
  • Prepare, analyze, and present safety data to internal and external safety monitoring boards.
  • Own presentations related to clinical trial data and contribute to abstracts, posters, manuscripts, and publications.
  • Support internal audits, regulatory inspections, advisory board meetings, and board meeting materials.

Requirements

  • 8+ years of experience in early- to late-stage development in an industry setting such as CRO and/or Pharma.
  • Experience planning and conducting clinical trials.
  • Experience delivering high-quality results within established timelines.
  • Experience working effectively in cross-functional teams across pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
  • Late-phase clinical trial experience in neurology is highly desirable.
  • Ability to thrive in a fast-paced environment and manage multiple priorities.
  • Strong attention to detail, analytical ability, problem-solving, and strategic planning skills.
  • Excellent written and oral communication skills and strong interpersonal skills for working with CROs, investigators, consultants, and internal teams.
  • Integrated understanding of FDA, EMA, ICH, and GCP guidelines; prior interaction with FDA and EMA is desirable.
  • MD, DO, or non-US equivalent degree; board certification in Neurology is strongly preferred.

Benefits

  • Salary range of $380,000 to $415,000 USD.
  • Equity and other forms of compensation may be included in the total package.
  • Full medical, dental, and vision coverage.
  • 401(k) plan.
  • Unlimited paid time off.
  • Parental leave.
  • Remote-based work environment.
  • Domestic or international travel required at 20%.

Interested in this position?

Apply directly on the company website

Apply Now

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