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About the Role

Our Clinical Pharmacology Team is looking for an Associate Director to support the Internal Medicine portfolio. We champion the innovative use of MIDD for efficient drug development and robust decision-making, offering an environment for learning and professional growth. The Clinical Pharmacology Lead will provide clinical pharmacology and MIDD expertise for clinical plans, project teams, and regulatory interactions, integrating PK/PD, patient characteristics, and disease knowledge for optimal development strategies.

Responsibilities

Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team, and other multifunctional teams.
Provide expertise, leadership, and deliverables of clinical pharmacology for assigned projects.
Design and execute clinical pharmacology plans and implement best practices.
Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge for human administration and predictive model establishment prior to FIH.
Plan and oversee clinical pharmacology aspects at the project level, including development plans, PK/PD analyses, and measurement strategies.
Plan and oversee study-level activities, including protocol authoring, clinical phase oversight, and reporting.
Ensure appropriate dose-range finding strategies with clinicians and statisticians to determine optimal doses and regimens.
Ensure appropriate design and implementation of End-to-End MIDD plans.
Utilize innovative analytical methods to integrate PK, PD, patient characteristics, and disease states for optimization.
Provide End-to-End clinical pharmacology contribution to regulatory documents.
Develop new methodologies through internal and/or external collaborations.
Coach less experienced colleagues and team members.
Stay abreast of literature, regulatory guidelines, and internal guidances and SOPs.
Influence external environment through publications, presentations, and representation at scientific societies and industrial consortiums.

Requirements

Demonstrates diverse leadership experiences and capabilities, including influencing and collaborating with peers, developing and coaching others, and guiding colleagues' work.
Strong quantitative skills and expertise (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.).
Intimate knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration.
Excellent written and verbal communication skills.
Demonstrated presentation skills.
Ability to attend global meetings periodically across different time zones.
Requires permanent work authorization in the United States.
U.S. work visa sponsorship is not available for this role now or in the future.

Skills

Clinical Pharmacology
MIDD (Model Informed Drug Discovery and Development)
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Quantitative Pharmacology
Mechanistic PK/PD modeling
Systems Pharmacology
Population modeling
Clinical trial simulations
NONMEM
R
Regulatory document contribution
Methodology development
Coaching
Literature review
Regulatory guideline adherence
Publication
Presentation

Location

Hybrid

Work Type

Hybrid

Experience Level

1+ year Industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.
5+ years Industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.

Education Level

M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
Pharm.D. or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.

Salary/Compensations

$139,100.00 - $231,900.00
Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary
Eligibility to participate in our share based long term incentive program.

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
Relocation assistance may be available
Eligible for Employee Referral Bonus

About the Company

Pfizer is a leader in model informed drug discovery and development (MIDD), and we are expanding in influence and impact.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users.

Equal Opportunity

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Pfizer is an E-Verify employer.
This position requires permanent work authorization in the United States.