Associate Clinical Pharmacology & Pharmacometrics Director

SUMMARY/JOB PURPOSE:

The Associate Clinical Pharmacology and Pharmacometrics Director has strong scientific, technical and leadership skills to contribute to development and implementation of clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of the development. Working closely with partners from discovery and development, the individual is responsible for providing subject matter expertise as a member of the project development team.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Develop and implement clinical pharmacology and pharmacometrics strategies to drive Exelixis programs through all the stages from research through post-marketing.
• Serves as the clinical pharmacology/pharmacometrics lead on 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 project and corporate objectives.
• Work with internal and external scientific experts to evaluate new methods to maintain cutting edge techniques, models, and capabilities.
• Assure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards in the clinical pharmacology programs.

SUPERVISORY RESPONSIBILITIES:

• None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• PhD or PharmD degree in pharmaceutical sciences, pharmacology or a related discipline and a minimum of 5 years of relevant drug development experience; or,
• Equivalent combination of education and experience.

Experience:

• Minimum 5 years experience in clinical pharmacology and/or pharmacometrics.
• Experience with development of small and/or large molecules and new modalities.
• Contributions to translational science and precision medicine objectives.

Knowledge, Skills and Abilities:

• In-depth understanding of the principles of clinical and quantitative pharmacology.
• Hands-on modeling and simulation skills using NONMEM, R and/or other modeling and simulation software.
• Current knowledge of regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biologics.
• Excellent interpersonal, verbal and written communication skills and the ability to convey complex technical information clearly.
• Ability to communicate and collaborate cross-functionally.
• Strong scientific leadership skills and the ability to influence.
• Ability to develop and deliver effective presentations and written/oral communications.
• Thrives in a fast-paced business environment.
• Applied knowledge of GLP and GCP regulations.
• Function in a highly matrixed team environment.
• Find creative solutions to unique and complex problems.

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.

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 this job.

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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.

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

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.