Senior Scientist II, DMPK

Role Summary

The Senior Scientist II, DMPK provides scientific direction and strategy to determine a potential safe and effective human dose through design, analysis, and interpretation of in vitro and in vivo pharmacology and DMPK experiments, including modeling and simulation. The role partners with medicinal chemistry, biology, toxicology, and pharmacology to drive programs forward and engage with stakeholders to achieve milestones. Primary responsibilities include generating hypotheses to improve the DMPK profile of drug candidates, planning and executing experiments, and integrating ADME with target pharmacology through modeling to support human dose projections.

Responsibilities

• Collaborate with discovery colleagues to evaluate compound properties for new compound selections; represent the department on project teams as the DMPK subject matter expert.
• Design and interpret PK, toxicology, and pharmacology studies with key stakeholders.
• Lead Modeling and Simulation efforts to relate drug concentration to PD/efficacy/toxicity and identify drug interaction liabilities.
• Partner with Discovery and Development leadership to evolve PK/PD and PBPK strategies and drive integration into Discovery projects.
• Work with Clinical Pharmacology to ensure seamless transition to Development and interaction with regulatory agencies.
• Maintain external scientific visibility through publication.
• Foster a science-driven, goal-oriented culture valuing innovation, teamwork, agility, transparency, accountability, and empowerment.
• Present scientifically to senior management, project teams, and internal/external collaborators.
• Comply with health and safety policies and general laboratory practices.

Qualifications

• Bachelor’s degree in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, Chemical Engineering or related field with a minimum of 9 years of experience; or
• Master’s degree in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, Chemical Engineering or related field with a minimum of 7 years of experience; or
• PhD degree in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, Chemical Engineering or related field with a minimum of 2 years of experience; or
• Equivalent combination of education and experience.

Experience

• Relevant experience in the biopharmaceutical industry with understanding of ADME concepts.
• Extensive experience with in vitro and in vivo ADME, including design, conduct, and interpretation of data.
• Experience applying DMPK in small molecule cancer drug development.
• Experience on Discovery project teams leading DMPK strategy through collaboration with Medicinal Chemistry, Biology, Pharmacology, Toxicology, and Pharmaceutical Sciences.
• Experience using Modeling and Simulation to relate drug concentration to PD, efficacy, and toxicity, and to identify drug interaction liabilities.
• Managing collaborations with CROs for outsourcing is preferred.
• Knowledge of regulatory requirements and experience interacting with regulatory agencies is a plus.

Knowledge/Skills/Abilities

• Scientific and technical knowledge of drug metabolism, enzymology, and enzyme kinetics.
• Ability to lead investigations into complex ADME issues requiring in-depth data analysis.
• Strong PK/PD fundamentals with hands-on PK/PD modeling experience (preclinical and/or clinical).
• Hands-on experience with PK/PD and/or PBPK software and programming (e.g., Phoenix WinNonlin, GastroPlus).
• Strong leadership and decision-making abilities.
• Excellent collaborative verbal and written communication skills.
• Ability to work independently, multi-task, and prioritize; experience working with cross-disciplinary teams.

Education

• As listed under Qualifications above.

Additional Requirements

• On-site in Alameda, CA; travel <10% to CROs and scientific conferences.