Clinical Pharmacology Lead, Manager

Role Summary

Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of drugs. Pfizer is a leader in model informed drug discovery and development (MIDD), and we are expanding in influence and impact. We have an open position as Clinical Pharmacology Lead supporting our End-to-End Internal Medicine portfolio. The ideal candidate is responsible for providing the clinical pharmacology and MIDD components of clinical plans and provide clinical pharmacology expertise to the project team and regulatory interactions. Working with multifunctional study team, Clinical Pharmacology Leads utilize innovative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections.

Responsibilities

• Act as Clinical Pharmacology representative on Clinical Sub Team, 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.
• With some guidance, 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.
• With some guidance, 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.
• With some guidance, 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.
• With some guidance, provide End-to-End clinical pharmacology contribution to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.).
• Stay abreast of literature, regulatory guidelines, and internal guidances and SOPs.
• Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium.

Qualifications

• Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
• 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.).
• 0+ years of industry experience
• 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 to achieve meaningful outcomes and create business impact.