Pfizer Associate Director, Clinical Pharmacology in Cambridge, Massachusetts
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.
Our Clinical Pharmacology Leads have key roles to play in influencing the discovery anddevelopment of drugs. It is exciting, critical work and you could be part of it. Pfizer is a leaderin model-based drug development, and we are expanding its influence in target validation andselection. We have an open position as Clinical Pharmacology Lead supporting our Research Unit in Cambridge, MA. The ideal candidate embraces model-based drugdevelopment - constructs, validates, and utilizes disease, placebo, exposure-response, andmechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, inclose collaboration with other R&D partners. Clinical Pharmacology Leads are also responsiblefor planning and direction of clinical pharmacology components of clinical programs (includingclinical development plan/life cycle plan) and studies (including protocol preparation; clinicalphase oversight, and reporting).
Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team asappropriate.* Participate in implementing model based drug development using quantitative approaches toaddress complex questions arising during drug development spanning from target validation toanalysis and interpretation of Phase II results.* Responsible for providing the clinical pharmacology components of Clinical Plans andprovides clinical pharmacology expertise to the project team including plan, design and overseeclinical pharmacology studies with operational assistance from operations colleagues* Fully knowledgeable about the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.* Coordinates with medical writers (and other team members) in the data review, analysis andreporting of the CP study. Responsible, in conjunction with medical writer, for overall contentand accuracy of study report before forwarding for final sign-off.* Accountable and responsible for non-compartmental analysis of PK data and accountable forensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation,meta-analysis etc.* Directs the planning of all relevant PK-PD analyses. Responsible for use of innovativeanalytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patientcharacteristics and disease states to optimize doses, dosage regimens and study designsthroughout clinical drug development in collaboration with pharmacometrics and statistics (asrelevant).* Provides recommendations for clinical doses and dosing algorithms (including drug interactionadvice, food effects, special group dosing etc) to the clinical and Development teams and inregulatory documentation.* Leads clinical pharmacology contributions to all regulatory documents including InvestigatorBrochures, EOP2 meetings. Leads the resolution of clinical pharmacology queries from drugregulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.* Provides Clinical Pharmacology expertise to Discovery. During the pre-clinical stages of drugdevelopment works with Research to ensure quantitative mechanistic understanding andpreclinical PK-PD knowledge exist to underwrite human administration.* Accountable for ensuring that there are valid methods for measuring drug concentration (andany biochemical biomarkers) in the clinic.* May participate in multidisciplinary teams in assessing potential in-licensing opportunities, asrequested by line management.* May act as clinician for phase I studies or clinical lead / research project lead for specific drugdevelopment projects.
Strong quantitative skills and expertise (e.g. experience in mechanistic PKPD modeling/systemspharmacology, literature meta-analyses, population modeling, and clinical trial simulations)* PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or othersuitable post-graduate qualification* 3-5 years of industry experience in clinical pharmacology and/or clinical PK/PD and/orpharmacometrics* 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.
Associate Director, Clinical Pharmacology Cambridge, Massachusetts 1040718