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 (MIDD), and we are expanding its influence in target validation and selection. We have an open position as Director, Clinical Pharmacology and Pharmacometrics supporting our Research Unit 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). RESPONSIBILITIES
- 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.
- Responsible for 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 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 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.
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring 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 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).
- Provides 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.
- Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings. Leads the resolution of clinical pharmacology queries from drug regulatory 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 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 participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
- May act as clinician for phase I studies or clinical lead / research project lead for specific drug development projects.
OTHER JOB DETAILS
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other suitable post-graduate qualification
- 8-15 years of industry 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, NONMEM)
- Excellent written and verbal communication skills
- Demonstrated presentation skills
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
- Eligible for Relocation Package (Domestic relocation to Cambridge, MA only)
- Eligible for Employee Referral Bonus
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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.