Position Description:
The Senior Director, Clinical Pharmacology and Pharmacometrics is expected to have exceptional technical and scientific leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies, including pharmacometrics, to advance the development of drug candidate across various stages of the development focusing on large molecules and new therapeutic modalities, including monoclonal antibodies, bispecifics and ADC. The individual will be responsible for clinical pharmacology/DMPK for biologics and advanced data analytics. The position reports to the Executive Director of Clinical Pharmacology and Pharmacometrics.

Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for pipeline delivery from discovery to Phase 4. Provide preclinical PK, toxicokinetics, and clinical PK/PD expertise to project teams. Progress biologics and new modalities through major milestones including IND/CTA, EOP2 and marketing applications.
• Provide advanced data analytics support to the translational medicine group, in addition to clinical pharmacology deliverables, including pharmacometrics, ML/AI and bioinformatics.
• Represent the clinical pharmacology function on project teams and take accountability for clinical pharmacology deliverables.
• Conduct PK/PD and exposure-response analyses using all relevant state of the art modeling and simulation techniques to support target identification, lead candidate selection, dose recommendation, trial design, Go/No-Go decisions, regulatory submission documents, and publications.
• Develop and implement clinical pharmacology and pharmacometric strategies to drive Exelixis biologics programs through all the stages from research development to the post-marketing.
• Work collaboratively with other CP-NCD leaders including Translational Medicine, Toxicology, and small molecule Clinical Pharmacology/DMPK.
• Network and collaborate with other functional areas including Biostats, Research, Clinical Development, Development Operations, Quality Assurance and Regulatory to deliver on project team and corporate objectives.
• Drive external scientific visibility and publication objectives.
• Work with other 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 group.

SUPERVISORY RESPONSIBILITIES:
Mentoring and supervising junior staff members

EDUCATION/EXPERIENCE/SKILLS:
Education:
PhD or MD in pharmaceutical sciences, pharmacology or a related discipline

Experience:
• Minimum 10 years' experience in clinical pharmacology and pharmacometrics.
• Preclinical and clinical development of large molecules and new modalities
• Submission of IND/BLA and global marketing applications
• Contributions to translational science and precision medicine objectives

Knowledge/Skills/Abilities:
• Expertise in pre- and clinical pharmacology, hands-on modeling and simulation skills using NONMEM, R and/or other modeling and simulation software. Experience with population PK models, advanced mechanistic PK/PD models, disease models, PBPK models is highly preferred
• Prior experience in nonclinical pharmacology and translational medicine is preferred
• Excellent interpersonal, verbal and written communication skills and the ability to convey complex technical information clearly
• Ability to communicate and collaborate with other functional areas including biostats, drug discovery, nonclinical safety assessment, CMC, clinical development, quality assurance and regulatory affairs
• Prior experience of impact on drug development through quantitative approaches with strong scientific leadership skills and the ability to influence
• Ability to develop and deliver effective presentations and written/oral communications
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions without complete information
• Ability to adapt, work through conflicts, and persuasively influence outcomes.
• Thrives in a fast-paced business environment
• Applied knowledge of GLP and GCP regulations

JOB COMPLEXITY:
• Function in a highly matrixed team environment
• Find solutions to unique and complex problems and provides creative solutions

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.

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