BBOT

Senior Director, Clinical Pharmacology

BBOT

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $265,000 - $280,000 per year

Job Level

Senior

About the role

  • Lead the clinical pharmacology strategy for multiple oncology programs, ensuring alignment with regulatory requirements and scientific standards.
  • Design and oversee clinical pharmacology studies to support multiple oncology program clinical development.
  • Collaborate with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to drive the advancement of drug development programs.
  • Drive application of model-informed drug development (MIDD) approaches, including population PK/PD and exposure–response analyses.
  • Author relevant sections/modules of regulatory documents (including INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossier) and serve as subject matter expert in regulatory interactions with FDA and other global health authorities.
  • Stay abreast of industry trends and advancements in clinical pharmacology and oncology, contributing to the scientific community through presentations and publications.

Requirements

  • Ph.D. or equivalent in pharmacokinetics (PK)/pharmacodynamics (PD), Pharmacology, Chemistry, or a related field.
  • Minimum of 10 years (SD) or 15 years (ED) of experience in clinical pharmacology, particularly with small molecule modality within the oncology therapeutic area.
  • Proven track record of successfully managing clinical pharmacology studies and developing regulatory submissions.
  • Strong understanding of oncology drug development processes and regulatory guidelines.
  • Quantitative pharmacology skillset preferred, e.g. PBPK, PK/PD modeling, population PK, and exposure-response analyses.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
Benefits
  • annual bonus
  • stock-based long-term incentives
  • medical
  • dental
  • vision benefits
  • retirement
  • wellness stipend
  • flexible time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical pharmacologypharmacokineticspharmacodynamicsmodel-informed drug developmentpopulation PK/PDexposure-response analysesregulatory submissionsquantitative pharmacologyPBPK modelingoncology drug development
Soft Skills
communication skillsinterpersonal skillscollaborationteamworkleadership
Certifications
Ph.D.