Clinical Pharmacology Associate II

Overview

SUMMARY/JOB PURPOSE (Basic purpose of the job):

The Clinical Pharmacology Associate II supports the clinical pharmacology and DMPK functions in pharmacokinetics (PK) data assembly, calculation, analysis, review, and documentation in addition to contributing to the multidisciplinary development teams by facilitating, designing, and executing pharmacokinetics analyses and data transfer between Exelixis and external vendors.

Location: Alameda, CA at Exelixis headquarters.

• Assist in the planning, design, analysis and implementation of PK data transfer plans between Exelixis and external vendors.
• Perform quality checks of nonclinical and clinical PK/TK data, reports, and regulatory document sections (e.g., IND, IB, NDA/BLA).
• Collaborate with clinical pharmacologists & DMPK scientists and cross-functional teams to analyze, verify, QC, and reconcile PK data from clinical and nonclinical studies.
• Support the archiving of final nonclinical DMPK and clinical PK data and reports.
• Conduct literature reviews to support PK study design and data interpretation.
• Coordinate and oversee external vendors and CROs conducting in vitro ADME and in vivo PK studies.
• Serve as liaison for outsourced DMPK studies, ensuring scientific quality, compliance and timely data delivery.
• Monitor study progress, troubleshoot issues and maintain comprehensive records of vendor communication and data tracking.
• Ensure DMPK data supports internal program goals through collaboration with Discovery, Toxicology, Regulatory and other functions.

• None.

Education:

• BS/BA in a relevant biological scientific discipline and a minimum of 3 years of related experience; or,
• Equivalent combination of education and experience.

Knowledge, Skills and Abilities:

• Excellent data analysis skills and experience with a variety of scientific software applications is preferred (Graph Pad-Prism, R, Win Nonlin, NONMEM, SAAM II).
• Proficiency with computers including MS Word, MS PowerPoint, and MS Excel is required.
• General knowledge of drug development, pharmacokinetics, pharmacology, drug metabolism, immunology theories and practices is a plus.
• Ability to perform in a fast-paced environment and ability to adapt to changing work conditions.
• Strong communication skills, excellent work ethic, self-motivation, and ability to work effectively in a team environment and independently.
• Collaborate with other project team members.
• Understanding of bioanalytical guidance and GLP/GxP regulations is a plus.
• Ability to work independently with supervision.
• Should be able to work multiple tasks and prioritize assignments.
• Able to work well with interdisciplinary teams representing Clinical Pharmacology and Translational Sciences
• Works on studies of diverse scope related to PK, ADME and PD principles; conducts analysis and review of data and provides evaluation of identifiable factors for problem solving; develops liaisons and interactions with other functions to provide PK, PD and some ADME resources for problem solving.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.

Work Environment/Physical Demands:
Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

Compensation & Benefits: Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $91,500 - $130,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, Exelixis offers a…