PK Bioanalysis Director

SUMMARY / JOB PURPOSE :

The Bioanalysis Director (BD) will manage outsourced regulated bioanalytical work for small molecules with LC-MS / MS in support of pharmacokinetic (PK) for nonclinical and clinical studies. They will possess strong technical expertise with LC-MSMS bioanalysis is essential. Knowledge of anti-drug antibodies (ADA) assay is preferred.

ESSENTIAL DUTIES / RESPONSIBILITIES :

• Lead outsourced bioanalysis and work with CRO to establish robust bioanalytical methods to support PK assays for nonclinical studies and clinical trials.
• Review method validation and sample analysis plans, protocols, data and reports to ensure scientific integrity and compliance with regulatory requirements.
• Serve as project manager for timelines, contracts, and budgets in support of outsourced projects.
• Contribute to regulatory filings.

SUPERVISORY RESPONSIBILITIES :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

Experience :

Knowledge, Skills and Abilities :

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.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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 $163,000 - $232,000 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, as part of our Total Rewards program, 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.

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.