The successful and highly motivated candidate will support the clinical pharmacology and nonclinical development in PK data review and documentation in addition to contributing to the multidisciplinary development teams by designing and executing pharmacokinetics data transfer between Exelixis and external vendors.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Assist in the planning, design and implementation PK data transfer plans from external vendors to Exelixis and from Exelixis to external vendors.
• Perform quality check of preclinical and clinical PK/TK data and reports and PK sections of regulatory documents (IND, IB, and NDA).
• Work with PK scientists and multiple functions to perform PK data cleaning and reconciliation for clinical studies.
• Support archiving of the final preclinical DMPK and clinical PK data and reports.
• Perform literature search to support PK data analysis.
• BS or MS in a relevant biological scientific discipline and zero to two 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.
• Proficiency with computers including MS Word, MS PowerPoint, and MS Excel is required.
• General knowledge of pharmacokinetics, pharmacology and immunology theories and practices is a plus.
• Ability to perform in a fast-paced environment and be flexible an ability to adapt to changing work conditions.
• Strong communication skills, excellent work ethic, self-motivation, and ability to work effectively in an either a team environment or independently.
• Collaborate with other project team members.
• Understanding of bioanalytical guidance and GLP/GxP regulations is a plus
• Ability to work independently.
• Should be able to multi-task and prioritize assignments.
• Able to work well with interdisciplinary teams representing Clinical Pharmacology and Nonclinical.
• Works on problems of diverse scope where analysis and review of data requires evaluation of identifiable factors and interactions with other functions.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.
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.