Pfizer Manager Clinical Pharmacology in Cambridge, Massachusetts
Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of drugs. It is exciting, critical work and you could be part of it. Pfizer is a leader in Model Based Drug Development, and we are expanding its influence in target validation and selection. We have an open position as Clinical Pharmacology Lead in Early Clinical Development in Cambridge, MA. The ideal candidate embraces model-based drug development - constructs, validates, and utilizes disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with other R&D partners. Clinical Pharmacology Leads are also responsible for planning and direction of clinical pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including protocol preparation; clinical phase oversight, and reporting).
With appropriate mentorship:
• Accountable and responsible for appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis, systems pharmacology etc.
• May act as Clinical Pharmacology representative on Clinical Sub Team and Development
Team as appropriate.
• Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase II results.
• Helps providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team including plan, design and oversee clinical pharmacology studies with operational assistance from Clinical Research Operations.
• Knowledgeable about the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.
• May help coordinating with medical writers (and other team members) in the data review, analysis and reporting of the CP study. Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off.
• Contribute to the planning and execution of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with Pharmacometrics and statistics (as relevant) or nonclinical modeling and simulation partners.
• Contribute recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation.
• Helps with clinical pharmacology contributions to selected regulatory documents including Investigator Brochures, EOP2 meetings. Helps the resolution of clinical pharmacology queries
from drug regulatory agencies, contributes in writing and reviewing responses to regulatory queries.
• Provides Clinical Pharmacology expertise to Discovery. During the pre-clinical stages of drug development works with Research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration.
• Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic.
• May act as clinician for phase I studies for specific drug development projects
• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other
suitable post-graduate qualification
• 0-3 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
Strong quantitative skills and expertise (e.g. experience in mechanistic PKPD modeling/systems
pharmacology, literature meta-analyses, population modeling, and clinical trial simulations)
• Excellent written and verbal communication skills
• Demonstrated presentation skills
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.
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Eligible for Employee Referral Bonus
Eligible for Relocation Package (REQUIRED IF BEING OFFERED)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.