Associate Director, Clinical Pharmacology Lead
Pfizer
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Connecticut • Massachusetts • United States
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Salary
💰 $124,400 - $207,400 per year
Job Level
About the role
- Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team and other multifunctional teams as appropriate
- Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence
- Design and execute clinical pharmacology plans and implement clinical pharmacology best practices on project teams
- Work closely with other disciplines to ensure that sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model prior to FIH
- Responsible for planning and overseeing clinical pharmacology aspects at the project level (e.g clinical development plan, implementation and interpretation of PK/PD analyses, PK/immunogenicity/biomarker measurement strategies etc.)
- Plan and oversee study level activities including protocol authoring, clinical phase oversight, and reporting
- Responsible (with clinicians and statisticians) for ensuring appropriate dose-range finding strategies which ultimately will lead to optimal doses and dosage regimens in patients
- Accountable for ensuring appropriate design and implementation of End-to-End MIDD plan that conforms with best practices
- Responsible for ensuring use of innovative analytical methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs
- Provide End-to-End clinical pharmacology contribution to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.)
- Develop new methodologies through internal and/or external collaborations with world leading experts
- Coach less experienced colleagues and team members
- Stay abreast of literature, regulatory guidelines, and internal guidance and SOPs
- Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium
Requirements
- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline
- 1+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology
- Intimate knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration
- Strong quantitative skills and expertise (e.g. experience in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.)
- 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.
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologypharmacokineticspharmacometricsmechanistic PK/PD modelingpopulation modelingclinical trial simulationsdose-range finding strategiesanalytical methodsbiomarker measurement strategiesquantitative pharmacology
Soft Skills
leadershipcommunicationcoachingcollaborationinfluencepresentation skillsoversightguidanceteamworkproblem-solving
Certifications
Pharm. D.M.D.Ph.D.