Director, Clinical Pharmacology

Role Summary

You will join an innovative and passionate clinical development team dedicated to improving the lives of patients suffering from devastating diseases. You will lead the clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs.

Responsibilities

• Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. You’ll be the Clinical Pharmacology lead for various programs in clinical development, the representative for regulatory interactions, and propose innovative strategies to get therapies to patients faster.
• Design clinical studies. You’ll provide clinical pharmacology input on all clinical study designs, from Phase 1-3 and dedicated Phase 1 clinical pharmacology studies.
• Author and review relevant clinical pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions. Act as the clinical pharmacology expert during interactions with health authorities.
• Interface with cross-functional teams. You’ll work closely with clinical study teams, translational teams (DMPK, Translational Modeling and Toxicology), preclinical teams and due diligence teams to ensure clinical pharmacology-related considerations are addressed.
• Solve drug development questions/problems by overseeing and/or performing modeling and simulation with various tools to expedite decision making.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D with a Clinical Pharmacology expertise, or a Pharm D. with a Clinical Pharmacology fellowship, with 5-9+ years of experience in biotech/pharmaceutical drug development.
• Demonstrated success leading all clinical pharmacology related aspects of drug development.
• Ability to work closely with internal and external stakeholders to manage PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations to support dose selection, exposure-response and exposure-safety analyses through various phases of drug development.
• Proficiency with WinNonlin, Monolix, NONMEM, R or other modeling software.
• Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders.
• Demonstrated experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions and attending regulatory meetings.
• Highly motivated, decisive, and results-oriented individual who is proactive, resourceful, and efficient with the flexibility and creativity to excel in and contribute to a rapidly growing drug discovery and development company.
• Experience in oncology is preferred, but not an absolute requirement.

Education

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