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

📋 Description

• Oversee the strategy and execution of clinical pharmacology and pharmacometrics for clinical programs related to rare diseases and oncology.

• Create clinical pharmacology and pharmacometric strategies that align with product development objectives.

• Act as the Clinical Pharmacology lead for clinical development initiatives and serve as a representative during regulatory discussions.

• Conduct and/or supervise modeling and simulation efforts to address drug development inquiries and accelerate decision-making processes.

• Provide insights on clinical pharmacology for Phase 1–3 clinical trials and 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 teams involved in clinical studies, translational research, preclinical efforts, and due diligence.

• Engage with Recursion’s Pharmacometrics team across both Discovery and Development initiatives.

⛳️ 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 drug development within the biotech or pharmaceutical industry.

• Proven track record of successfully leading all aspects of clinical pharmacology in drug development.

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

• Expertise with modeling software such as WinNonlin, Monolix, NONMEM, R, or similar tools.

• Experience in addressing inquiries from regulatory agencies, preparing clinical pharmacology components of regulatory submissions, and participating in regulatory meetings.

• Strong ability to collaborate with both internal and external stakeholders.

• Prior experience in oncology is preferred, but not mandatory.