1+ months

Director, Clinical Pharmacology Lead

La Jolla, CA 92037
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**Role Summary**

Clinical Pharmacology Leads at Pfizer are responsible for developing and implementing the clinical pharmacology components of Clinical Development Plans, and providing clinical pharmacology expertise to drug development project teams.

Clinical Pharmacology Leads utilize innovative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections.

We are seeking to hire a Director to join the Clinical Pharmacology Group within the Early Oncology Development and Clinical Research organization, based in San Diego, CA. The individual will be responsible for developing and delivering the clinical pharmacology and modeling & simulation strategy for early oncology programs, from first-in-patient to proof-of-concept. The ideal candidate should have hands-on experience in both clinical pharmacology support for oncology programs and mechanistic mathematical modeling as demonstrated through publications.

**Role Responsibilities**

Develop clinical pharmacology plan for early oncology drug development programs, including both small and large molecules

Act as clinical pharmacology subject matter expert on multidisciplinary teams working closely with clinicians, biostatisticians, translational oncology and clinical operations colleagues to design, conduct and report clinical trials from first-in-patient to proof-of-concept; responsible for clinical pharmacology components including pharmacokinetics, pharmacodynamics, food effect (oral compound), drug-drug interaction, QTc, and immunogenicity (biologics).

Collaborate with preclinical scientists and analyze translational models developed from preclinical data to ensure adequate confidence in prediction of human PK and efficacious dose projections.

Provide scientific justification for optimal human starting dose and dose escalation schemes for first-in-patient protocols based on all available preclinical information including toxicology, efficacy models, physicochemical and biochemical characterization.

Work closely with clinical assay specialists to ensure that appropriate and validated bioanalytical assays are available on time for measuring drug concentration and anti-drug antibodies (for biologics) for clinical studies.

Conduct PK data analysis and develop computational models from PK/PD, safety and efficacy data collected in early stage clinical trials to support key program decision-making.

Present clinical pharmacology results to internal and external stakeholders.

Author clinical pharmacology components of clinical documents including protocols, investigator brochures, clinical development plans, and study reports; author scientific publications.

Align with global clinical pharmacology groups at Pfizer to maintain consistency with best practices and ensure the state-of-the-art quantitative approaches are being applied to inform key drug development decisions.

**Basic Qualifications**

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

A PhD, PharmD, or equivalent advanced degree in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, or other related disciplines.

8-15 years of post-graduate experience in clinical drug development.

Proficiency in mathematical modeling and programming as demonstrated by hand-on experience in computational tools (e.g. R/S-plus, MATLAB, NONMEM).

Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.

Excellent verbal and written communication skills.

Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.

Prior experience in supporting clinical pharmacology for oncology drug development is desirable.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


Relocation eligible

Eligible for employee referral bonus


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-10-04 Expires: 2019-12-05

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Director, Clinical Pharmacology Lead

La Jolla, CA 92037

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