12 days old

Principal Scientist, BioMedicine Design

Cambridge, MA 02139
**Role Summary**

Responsible for the oversight of a number of projects within Research Units and providing BioMedicine Design - Pharmacokinetics, Dynamics & Metabolism (BMD-PDM) - focused leadership and strategic direction to assigned projects from early discovery through loss of exclusivity.

**Role Responsibilities**

+ Identifies key BMD-PDM related project attrition risks and in collaboration with internal BMD stakeholders creates and integrates this risk-mitigation strategy into the overarching project strategy.

+ Works with the project team and key personnel in BMD-PDM to implement risk mitigation strategies and the regulatory documentation required in PDM to progress programs out to a key go/no go decision point in discovery and development.

+ Ensures execution of the BMD-PDM strategy in partnership with BMD scientists. For example, works with bioanalytical scientists to ensure the development of appropriate assays;, interfaces with biomarker scientists, PK/PD modelers and other biotherapeutic BMD-PDM partners to develop quantitative translational pharmacology plans; ensures appropriate PK predictions and dose projection approaches; and develops immunogenicity risk assessment and mitigation strategies.

+ As the BMD-PDM lead to project teams, the scientist is expected to integrate nonclinical pharmacokinetic, pharmacodynamic and metabolism knowledge, influence the preclinical project plans, and drive optimization of biotherapeutic molecules in collaboration with BMD protein engineers.

+ The candidate will also advance the science and strategies for prosecuting biotherapeutic projects as well as influence external scientific and regulatory practices through publication and other interactions.

+ Liaises with: Core discipline groups within BMD, and interacts with the Project Leader and scientists in Biology departments, Drug Safety, Pharmaceutical Sciences, and Clinical departments at all stages of discovery and development.

**Basic Qualifications**

+ PhD with >5 years of work experience (of which at least 2 years are in the pharmaceutical industry) in Pharmacokinetics, PK/PD, or relevant field (or MS/BS with 10 or more years)

+ Understanding of the basic principles of pharmacokinetics (non-compartmental, compartmental)

+ Working knowledge in the pharmacokinetics and disposition of biotherapeutic modalities.

+ Understanding of immunological and other biotherapeutic bioanalytical assays.

+ General understanding of PK/PD modeling and the application to advance projects from idea to clinical development.

+ Experience integrating data from multiple sources into a rational understanding of absorption, distribution, clearance, PK/PD, and immunogenicity.

+ Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model.

+ Excellent oral, written, and presentation skills. Demonstrated through internal and external presentations.

+ Excellent interpersonal relationship skills.

**Preferred Qualifications**

+ Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of regulatory guidelines is preferred.

+ Ability to perform and communicate mathematical calculations and ability to perform complex data analysis.

+ Occasional business travel and due to the global nature of the projects supported, occasional flexibility in timing of work hours.

**Other Job Details:**

+ **Last Date to Apply for Job: October 22, 2020**

+ Eligible for Relocation Package: YES

+ Eligible for Employee Referral Bonus: YES


**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.

Research and Development


Posted: 2020-10-13 Expires: 2020-11-12

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Principal Scientist, BioMedicine Design

Cambridge, MA 02139

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