Clinical Pharmacology Associate II

Exelixis • Alameda, CA

3d • Onsite

About The Position

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. This role is located in Alameda, CA at Exelixis beautiful headquarters.

Requirements

• BS/BA in a relevant biological scientific discipline and a minimum of 3 years of related experience; or, Equivalent combination of education and experience.
• Excellent data analysis skills and experience with a variety of scientific software applications is preferred (GraphPad-Prism, R, WinNonlin, NONMEM, SAAM II).
• Proficiency with computers including MS Word, MS PowerPoint, and MS Excel is required.
• 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.
• 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.

Nice To Haves

• General knowledge of drug development, pharmacokinetics, pharmacology, drug metabolism, immunology theories and practices is a plus.
• Understanding of bioanalytical guidance and GLP/GxP regulations is a plus.

Responsibilities

• 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.

Benefits

• Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level