Senior Clinical Pharmacologist I

Exelixis•Alameda, CA

5d•Onsite

About The Position

The Senior Clinical Pharmacologist I has strong scientific and technical skills to implement clinical pharmacology and modeling and simulation strategies to advance drug candidates across various stages of development. Working closely with partners from discovery and development, the individual is responsible for providing technical subject matter expertise as a member of study or project development teams.

Requirements

PhD in Pharmaceutical Sciences or a related field with focus on pharmacokinetics and pharmacodynamics and zero or more years of related experience; or, Equivalent combination of education and experience.
Prior research projects focused on preclinical or clinical pharmacokinetics, pharmacodynamics and modeling and simulations.
In-depth understanding of the principles of clinical and quantitative pharmacology.
Familiarity of regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biologics.
Strong interpersonal, verbal, and written communication skills and the ability to convey complex technical information clearly.
Ability to communicate and collaborate cross-functionally.
Ability to develop and deliver effective presentations and written/oral communications.
Thrives in a fast-paced business environment.
Function in a highly matrixed team environment.
Find creative solutions to unique and complex problems.

Nice To Haves

Candidates with hands-on modeling and simulation skills using NONMEM, R and/or other modeling and simulation software are preferred.

Responsibilities

Implement clinical pharmacology and pharmacometrics strategies to drive Exelixis programs through all the stages from research through post-marketing.
Serve as the clinical pharmacology/pharmacometrics lead on study or project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions and quantitative pharmacology.
Progress small molecules and biologics through development milestones including IND/CTA, EOP2 and marketing applications.
Conduct PK/PD and exposure-response analyses using relevant state-of-the-art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions and publications.
Work collaboratively with functional partners including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations and Regulatory to deliver on study and project team objectives.
Assure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards in clinical pharmacology programs.