Manager, Clinical Pharmacology

About the role

The Clinical Pharmacology Team is seeking a Manager to support the Internal Medicine portfolio. The role involves championing the innovative use of Model-Informed Drug Development (MIDD) for efficient drug development and robust decision-making.

Responsibilities

• Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team and other multifunctional teams as appropriate.
• Provide 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 sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and establish the structure of a predictive model prior to First-in-Human (FIH).
• Plan and oversee study level activities including protocol authoring, clinical phase oversight, and reporting.
• Ensure appropriate design and implementation of End-to-End MIDD plan that conforms with best practices.
• Incorporate innovative analytical methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
• Contribute to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.)
• Stay updated with literature, regulatory guidelines, and internal guidances and SOPs.
• Influence external environment through publications, presentations, and representation at scientific societies and industrial consortiums.

Qualifications

• 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.).
• M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
• 0+ years of industry experience.
• Pharm D. or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
• 2+ years of industry experience.
• Excellent written and verbal communication skills.
• Demonstrated presentation skills.
• Ability to work in global team meetings across different time zones periodically based on business necessity.
• 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.

Other Job Details

Eligible for Relocation Package: YES
Eligible for Employee Referral Bonus: YES
Work Location Assignment: Hybrid
Annual Base Salary Range: $106,000.00 - $176,600.00
Bonus Target: 15.0% of the base salary
Participation in Pfizer’s Global Performance Plan
Participation in share based long term incentive program
Comprehensive and generous benefits and programs to support a healthy lifestyle and life's moments.
Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage.