Senior Director, Clinical Pharmacology

3 weeks, 2 days ago
Full-time
Lead
Operations
Pharmaceuticals
51-250
Founded 2018
$725M raised

Description

  • Serve as the head of clinical pharmacology and lead the function across all indications.
  • Develop clinical pharmacology strategy for Immunovant compounds and oversee clinical pharmacology study design, interpretation, and conduct.
  • Provide clinical pharmacology support for Phase 1, Phase 2, and Phase 3 studies.
  • Support regulatory submissions by writing and reviewing relevant clinical pharmacology sections.
  • Provide data analysis, modeling, and simulation to support asset development and dosing decisions.
  • Perform or oversee pharmacometrics analyses conducted by external resources.
  • Collaborate with Regulatory on INDs, health authority inquiries, meetings, BLA sections, review responses, and advisory committee preparation.
  • Support cross-functional teams including Statistics, Data Management, Clinical, Preclinical/Nonclinical, and Translational Science.

Requirements

  • PhD, PharmD, or MD with training in clinical pharmacology, PK/PD, pharmacology, or pharmaceutical sciences.
  • 8-10 years of experience applying clinical pharmacology in drug development within the healthcare industry.
  • Experience leading clinical pharmacology regulatory submissions and approvals for at least one original or major NDA/CTD or multiple supplemental NDA/CTDs.
  • Proven track record supporting regulatory submissions such as EoP2, IND, NDA, MAA, and PIP.
  • Experience with pharmacokinetic/pharmacometric methods and software such as NONMEM and WinNonlin.
  • Deep understanding of drug development and integration across nonclinical, clinical, CMC, regulatory, finance, and legal functions.
  • Knowledge of regulatory expectations for clinical pharmacology.
  • Excellent written and oral communication skills with strong attention to detail.
  • Ability to thrive in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment.
  • Strong collaboration skills and comfort working on cross-functional teams.

Benefits

  • Salary range of $250,000 to $305,000 USD.
  • Equity and other forms of compensation may be provided as part of the total compensation package.
  • Medical, dental, and vision insurance.
  • 401(k) benefits.
  • Unlimited paid time off.
  • Parental leave.
  • Flexible remote work arrangement.
  • Domestic or international travel may be required at less than 10%.

Interested in this position?

Apply directly on the company website

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