Posted:
11/10/2024, 4:00:00 PM
Location(s):
Massachusetts, United States ⋅ Andover, Massachusetts, United States ⋅ Cambridge, Massachusetts, United States
Experience Level(s):
Senior
Field(s):
Medical, Clinical & Veterinary
Why Patients Need You
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.
What You Will Achieve
In this role, you will be joining a dynamic group of discovery/development project team representatives within the Pharmacokinetics, Dynamics and Metabolism (PDM) Department at Pfizer Cambridge, Massachusetts. Working with multidisciplinary biotherapeutics drug discovery project teams, you will provide strategic direction to the project teams by integrating nonclinical pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity knowledge to influence the project plans and drive optimization of biotherapeutic molecules. While doing so, you will collaborate with protein engineers and work closely in a PDM matrix-team environment with bioanalytical, biomarkers/biomeasures and immunogenicity scientists to ensure the execution of appropriate experimental plans, data interpretation, bioanalytical assay development, and immunogenicity risk and mitigation plans. You will also interface with pharmacologists, PK/PD modelers and clinical pharmacokineticists to develop a translational pharmacology plan and human PK and efficacious dose projections for clinical candidates.
As a PDM point-of-contact for the discovery project team, you will work with Project Team Leaders and team representatives from BioMedicine Design, Pharmacology, Drug Safety, Pharmaceutical Sciences, and Clinical departments. You will utilize PDM knowledge gathered from in vitro and in vivo studies to influence all stages of the discovery process including the hit-to-lead, lead development, and candidate nomination phases. Post-candidate nomination, you will interface with the asset development team and coordinate PDM support (e.g., validated TK/ADA assays) for regulated toxicity studies and will prepare the regulatory dossier and respond to regulatory queries.
How You Will Achieve It
Application of functional/technical knowledge to design in vitro and in vivo PK/ADME studies and immunogenicity assessments in collaboration with the PDM matrix team to drive decisions in drug discovery/development programs
Provide strategic direction to multidisciplinary project teams through interpretation and effective communication of PK/ADME and immunogenicity data
Ensure effective usage of internal and external PDM resources to deliver upon project milestones
Advance scientific and technology innovation and excellence that translates into portfolio impact
Qualifications
Must-Have
Ph.D. with >1 year of work experience in the pharmaceutical industry or at least 1 year of post-doctoral experience in Pharmacokinetics, PK/PD, or relevant field OR MS/BS degree with 5 or more years
Highly effective written, presentation and verbal communication skills, demonstrated through internal and external presentation
Ability to communicate/collaborate effectively with multidisciplinary scientists in a research environment
Understanding of the basic principles of pharmacokinetics (non-compartmental, compartmental)
Working knowledge in the pharmacokinetics and disposition of biotherapeutic modalities
Nice-to-Have
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
General understanding of integrating data from multiple sources into a rational understanding of absorption, distribution, clearance, PK/PD, and immunogenicity.
Some knowledge in the preparation of regulatory applications (IND, NDA, BLA) and regulatory guidelines
Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model.
Excellent interpersonal relationship skills.
PHYSICAL/MENTAL REQUIREMENTS
Sitting, standing, lifting, bending, and walking. Ability to work on a computer (while standing or sitting).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Relocation support available
Work Location Assignment: Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine