Senior Scientist II, DMPK

SUMMARY: The Senior Scientist II, DMPK works with a fast-paced team in drug discovery research to provide scientific direction and strategy to find a potential safe and effective human dose through the design, analysis, and interpretation of in vitro and in vivo pharmacology and DMPK experiments along with modeling and simulation. The successful candidate will utilize their strong knowledge in ADME and PK/PD to equally partner with team members within medicinal chemistry, biology, toxicology, and pharmacology, to drive programs forward and to actively engage with key stakeholders and leaders to achieve critical milestones for Exelixis' pipeline. Primary responsibilities will be to generate hypotheses to improve the DMPK profile of drug candidates, independently plan and execute experiments through data-driven approaches, and integrate ADME with the pharmacology of target(s) through modeling and simulations to support human dose projections.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Collaborate with discovery colleagues to evaluate compound properties for new compound selections; represent the department on project teams as the subject matter expert on DMPK.
• Work with key stakeholders to design and to interpret PK, toxicology and pharmacology studies.
• Lead Modeling and Simulation efforts to establish relationship between drug concentration to PD/efficacy/toxicity and to identify potential drug interaction liabilities.
• Closely partner with Discovery and Development leadership to evolve PK/PD and PBPK strategies, and lead roll-out, education and execution to ensure deep integration into Discovery projects.
• Closely partner with Clinical Pharmacology to ensure a seamless transition to Development and to enhance interaction with regulatory agencies.
• Maintain external scientific visibility through publication.
• Foster a science-driven, goal-oriented culture that values innovation, teamwork, agility, transparency, accountability, and empowerment
• Conduct scientific presentations to senior management, project teams, and internal/external collaborators.
• Comply with company health and safety policies and general laboratory practices.

SUPERVISORY RESPONSIBILITIES:

• May manage scientists within Drug Discovery Sciences.
  

EDUCATION/EXPERIENCE/SKILLS:

Education:

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

Experience:

• Relevant experience in the biopharmaceutical industry with a good understanding of ADME concepts.
• Extensive experience with in vitro and in vivo ADME, including design, conduct and interpretation of data.
• Direct industry or related experience in the application of DMPK within the context of small molecule cancer drug development.
• Experience with working on Discovery project teams, leading DMPK strategy through collaboration with Medicinal Chemistry, Biology, Pharmacology, Toxicology, Pharmaceutical Sciences, etc.
• Experience in utilizing Modeling and Simulation to establish relationship between drug concentration to PD, efficacy and toxicity as well as to identify drug interaction liabilities.
• Manage collaborations with CROs for outsourcing activities is preferred
• Knowledge with regulatory requirements and experience interacting with regulatory agencies is a plus.

Knowledge/Skills/Abilities:

• Scientific and technical knowledge around drug metabolism, including enzymology and enzyme kinetics
• Lead investigation into complex ADME issues where analysis of situations or data requires an in-depth evaluation of factors.
• A solid understanding of fundamental pharmacokinetic and quantitative pharmacology (PK/PD) principles with hands-on skills in PK/PD modeling of preclinical and/or clinical data.
• Excellent hands-on knowledge with PK/PD and/or PBPK software and programming skills (e.g., Phoenix WinNonlin and Gastroplus).
• Demonstrates strong leadership; the ability to influence and make decisions.
• Excellent collaborative verbal and written communication skills.
• Effectively works independently; and is capable in multi-task and prioritizing assignments.

• Able to work well with multi-disciplinary teams, building networks with key contacts outside own area of expertise

WORKING CONDITIONS

• On-site in Alameda, CA
• Travel <10% to CROs and scientific conference(s)
  

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DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.