Pharmacokinetics, Dynamics & Metabolism Project Representative - Senior Principal Scientist

  • Company: Pfizer
  • Location: San Diego, California
  • Posted: January 21, 2017
  • Reference ID: 1045902

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. ROLE SUMMARY The PDM Project Representative is responsible for the oversight of a number of projects primarily within the ORU PDM group providing scientific leadership and strategic direction to assigned projects from idea to POC. Accountable for ADME optimization, PK predictions and ADME related development activities. Works with bioanalytical and ADME scientists to ensure the appropriate experimental plans. 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 project team, he/she will synthesize the PDM knowledge, influence the preclinical project plans and optimization of the therapeutic. The candidate will also partner with other PDM scientific leaders to advance the ADME science and strategies for prosecuting primarily small molecule projects and may also influence external scientific and regulatory practices through publication and other interactions. QUALIFICATIONS • PhD level education (or MS/BS) with 10 or more years in relevant field. • Industry experience in DM/PK and a strong record of scientific achievement & project influence required. • Experience in the preparation of regulatory applications (IND, NDA) and good knowledge of regulatory guidelines is highly desirable. • Proven track record of influence projects and project teams, particularly in areas of emerging science. • Experience integrating DM/PK discipline knowledge into broader project team to help guide project decisions. • Extensive practical experience of project liaison and achieving results in a matrix environment. • Experience in drug discovery / development up to POC. • Excellent presentation skills as demonstrated through internal and external presentations. • Proven track record in the area of mentoring and coaching. Skills: PK and disposition. Mechanistic modeling of pharmacokinetics (PK). SimCYP experience preferred. Broad understanding ADME and in vitro drug metabolizing enzyme and transporter assays. General knowledge of biotransformation and physical organic chemistry. Understanding of bioanalytical sciences generally by LC-MS/MS. General understanding of PK/PD modeling and its application to advance projects. Demonstrates ability to integrate data from multiple sources in to a rational understanding of drug disposition. Proficiency in human PK predictions. General understanding of drug discovery, chemistry and pharmacology- Oncology preferred. Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Approximately 1 or 2 times a year travel to Groton, CT for collaborative work. 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. Additional Offer Details: This job is Pfizer Exempt US Grade:13 Eligible for Relocation Package 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.

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