Manager, Clinical Pharmacology

About the role

The role involves supporting the Internal Medicine portfolio with key roles in the discovery and development of drugs. Pfizer is expanding its influence and impact in model informed drug discovery and development (MIDD).

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 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.
• 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.).
• 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

• 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 to $176,600.00
• Participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program.
• Comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of 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.