17 days old

Senior Principal Scientist, DMPK

San Diego, CA
**Senior Principal Scientist (R6)**

+ **ROLE SUMMARY** Responsible for representing PDM in discovery and development projects primarily but not limited to the Oncology Research and Business Unit and providing direction of DMPK strategy to the project/asset/medicine team and to PDM/Med Deign functional lines and other partner lines from idea to optimization to regulatory submissions (including NDA and global submissions). **ROLE RESPONSIBILITIES**

+ Responsible for representing PDM in projects primarily within the Oncology Business and Research Unit.

+ Formulate DMPK strategy and asset plan in support of discovery and development assets from idea to optimization to regulatory submissions (including NDA and global submissions).

+ Works with PDM matrix team including bioanalytical and ADME scientists to ensure the appropriate experimental plans are designed and executed to support project advancement through various milestones.

+ Interfaces with the biomarker scientists, PK/PD modelers and Research Unit partners to develop the translational pharmacology plan, PK predictions and dose projections for small molecule therapeutics.

+ As PDM representative to the discovery project team, he/she will synthesize the PDM knowledge and influence the preclinical project plans and optimization of the therapeutic in a resource responsible manner.

+ The project representative will interface with the asset development team to support the design and interpretation of ADME, drug interaction and special population PK studies, to prepare the regulatory dossier and respond to reviewer queries.

+ The candidate will also partner with other PDM scientists to advance the ADME science and strategies for prosecuting small molecule projects


+ PhD level education with 7-10 years (or MS/BS with 15 or more years) in relevant chemistry, biology, or biomedical fields;

+ Knowledge in pharmacokinetics and drug disposition and skill in one or multiple DMPK functional discipline (e.g. enzymology, transporter, bioanalytical, biotransformation, biomarker) required;

+ Industry experience in managing and execution of DM/PK program and a strong record of scientific achievement via presentations and/or publication in peer reviewed journals;

+ Thorough understanding of regulatory guidelines (US, EU and/or ICH) and requirement for IND/CTA and NDA submissions required; knowledge and experience in regulatory interaction (meetings and responses) with other agencies desired;

+ Excellent communication skills, both verbally and written, by way of discussion, presentation, and scientific writing to summarize asset knowledge and presenting company position;

+ Experience integrating DM/PK discipline knowledge to help guide ADME strategy decisions;

+ Experience in project liaison and achieving results in a matrix environment.

+ Proven track record of influence projects, particularly in areas of emerging ADME and translational sciences;

+ Experience in drug discovery and/or development preferred.

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.

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.

**Other Job Details:**

+ **Last Date to Apply for Job:** September 15, 2018

+ Eligible for Relocation Package; yes

+ Eligible for Employee Referral Bonus: yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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Senior Principal Scientist, DMPK

San Diego, CA

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