Clinical Pharmacology Leads at Pfizer are key members of multidisciplinary drug development project teams who provide subject matter expertise in quantitative pharmacology and are uniquely positioned to work at a technical level while having the opportunity to influence drug development strategy within the organization. Working closely with colleagues across research and development Clinical Pharmacology Leads apply their technical expertise to analyze, develop, validate and implement quantitative models to inform key drug development decisions. They are also responsible for design, conduct, oversight and reporting of clinical pharmacology components of clinical programs and studies.
We are seeking to hire a Clinical Pharmacology Lead to join the Clinical Pharmacology team within the Early Clinical Development, based in Cambridge, MA. The individual will be responsible for developing and delivering modeling/simulation and clinical pharmacology strategies for early development programs using state-of-the-art quantitative methodologies to integrate knowledge of disease biology, pharmacology, pharmacokinetics (PK), pharmacodynamics (PD) and competitors.
ROLE AND 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 and – as appropriate – responsible 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, statistics and QSP (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 IND, CTA, 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 Drug 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.
- Advanced degree (Ph.D., Pharm.D., MD) or equivalent experience in Pharmacokinetics, Pharmacometrics, or other related disciplines.
- Experience in clinical pharmacology and/or pharmacometrics and/or translational modeling.
- Proficiency in mathematical modeling and programming as demonstrated by hand-on experience in computational tools (e.g. R, NONMEM, SimCYP/GastroPlus).
- Demonstrated ability to work in a highly collaborative, multi-disciplinary, and multi-site team setting.
- Excellent verbal and written communication skills.
- Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.
Other Job Details:
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES