Hybrid Clinical Pharmacology Lead

at Pfizer

• Job title: Clinical Pharmacology Lead
• Job type: Full Time
• Experience level: Senior
• Salary: $106,000 - $176,600 per year
• Degree requirement: Professional Certificate
• Location requirements: Hybrid, Cambridge, United States

About the role

• Clinical Pharmacology Lead managing drug development strategies in Internal Medicine. Working with multifunctional teams to optimize clinical pharmacology methodologies and regulatory compliance.

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.

Requirements

• 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.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an 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