Associate Director/Director, Clinical Pharmacology and Pharmacometrics

Role Summary

The Associate Director or Director, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology, clinical pharmacology strategy, and oncology drug development. This role reports to the SD or ED of Clinical Pharmacology and Pharmacometrics. Location: Washington State.

Responsibilities

• Excellent written/oral communication, interpersonal and problem-solving skills.
• Formulate and deliver CP&MS strategy for late-stage and early preclinical/clinical development assets.
• Apply pharmacokinetic/pharmacodynamics (PK/PD), physiologic based PK (PBPK) and pharmacometric modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions.
• Work with preclinical and clinical CROs and company scientists to conduct and monitor clinical pharmacology studies, maintain study records and ensure study completion along program timelines.
• Contribute and drive program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.

Qualifications

• Ph.D. in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline)
• A minimum of 4 years' experience in pharmaceutical/biotechnology industry in regulated bioanalytical environment, preferably with multiple modalities, including small molecule, large molecule and ADC experience.
• Extensive experience in noncompartmental and PBPK analyses and pharmacometric modeling and simulation oversight including use of WINNONLIN, NONMEM, MONOLIX or similar statistical modeling software
• Knowledge of R, R-shiny, SAS, MATLAB, NONMEM, MONOLIX, PBPK (gastroplus or Simcyp) or similar modeling software and substantial experience integrating quantitative clinical pharmacology with oncology drug development strategy

Skills

• Familiarity with current global clinical pharmacology and pharmacometrics regulatory guidance.
• Experience in successful submission of at least one global filing for approval (NDA/BLA).
• Extensive experience managing relationships with clinical pharmacology vendors.
• Experience of development of anti-cancer agents, preferably ADCs and/or RLTs.
• Excellent written/oral communication, interpersonal and problem-solving skills.
• Experience in oncology drug development with small a large molecule clinical pharmacology strategy. Experience in translational aspects of drug discovery and development is strongly preferred.
• Ability to deliver integrated clinical pharmacology roadmap to registration and new product label.
• Can manage multiple project related workstreams simultaneously under tight timelines collaboratively.
• Experience managing clinical pharmacology related data transfers, analysis, reporting and related timelines.
• Experience interacting with global health authorities on optimal dosage design and clinical pharmacology strategy. Effective forms of written and spoken communication is essential (eg clinical pharmacology protocols, pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control).
• Knowledge of regulatory requirements governing drug development.
• Resourcefulness, pragmatism, creativity and an independent work ethic.