Executive Director, Clinical Pharmacology – Pharmacometrics

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee the strategy and implementation of clinical pharmacology and pharmacometrics for clinical programs in rare diseases and oncology.

• Formulate strategies that align with product development plans and act as the Clinical Pharmacology lead for ongoing clinical projects.

• Represent the organization in regulatory discussions and propose innovative strategies to expedite the delivery of therapies to patients.

• Conduct and/or supervise modeling and simulation efforts to inform drug development decisions.

• Provide expertise in clinical pharmacology for Phase 1–3 clinical study designs as well as specialized Phase 1 clinical pharmacology studies.

• Write and review clinical pharmacology sections for Investigator's Brochures, INDs, NDAs, and other regulatory documents.

• Serve as a clinical pharmacology authority during interactions with health authorities.

• Collaborate with clinical study, translational, preclinical, and due diligence teams.

• Work in partnership with clinical development and discovery teams throughout the entire drug discovery and development process.

⛳️ Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or a related field; M.D. with expertise in Clinical Pharmacology; or Pharm D. with a Clinical Pharmacology fellowship.

• Over 10 years of experience in biotech or pharmaceutical drug development.

• Proven track record of successfully leading all clinical pharmacology-related elements of drug development.

• Competence in managing PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations.

• Proficient in using WinNonlin, Monolix, NONMEM, R, or other modeling software.

• Experience in addressing regulatory agency inquiries, preparing clinical pharmacology sections for regulatory submissions, and participating in regulatory meetings.

• Oncology experience is preferred but not mandatory.

• Strong collaboration skills with internal and external stakeholders and ability to resolve conflicts effectively.

• Highly driven, decisive, results-oriented, proactive, resourceful, efficient, flexible, and innovative.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Comprehensive benefits package.

• Periodic travel required.

• Accommodations available upon request during the selection process.