Pfizer · 5 hours ago
Associate Director, Clinical Pharmacology
Pfizer is a global biopharmaceutical company, and they are seeking an Associate Director of Clinical Pharmacology to lead clinical pharmacology efforts in oncology programs. The role involves providing expertise in clinical pharmacology, overseeing study designs, and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Represent Clinical Pharmacology on Clinical Sub Team and Development Team
Participate in the implementation of 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 III results
Provide 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
Serve as an expert on the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol
Coordinate with Medical Writers (and other team members) in the data review, analysis and reporting of the CP study. Share responsibility with Medical Writer, for overall content and accuracy of study report before forwarding for final sign-off
Responsible and accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and meta-analysis
Directs the planning of all relevant PK-PD analyses. Use 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)
Provide 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 and interactions
Provide Clinical Pharmacology expertise to Discovery during the pre-clinical stages of drug development and works with Research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration
Ensure that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic
Participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management
As necessary, act as clinician for Phase I studies or clinical lead / research project lead for specific drug development projects
Qualification
Required
PhD or PharmD
3+ years of related experience
Experience applying pharmacokinetic and pharmacokinetic-pharmacodynamic concepts, including modeling and simulation to clinical trial design
Clinical drug development experience in oncology or other therapeutic area
Strong communication skills--written, verbal and presentation
Preferred
Strong technical proficiency with pharmacokinetic software (e.g., WinNonlin, NONMEM, S-Plus, R)
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
Benefits
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Company
Pfizer
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
Funding
Current Stage
Public CompanyTotal Funding
$38BKey Investors
Starboard Value
2025-11-21Post Ipo Debt· $6B
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B
Recent News
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