About the Role
Our Clinical Pharmacology Team is looking for a Manager to support the exciting portfolio in Internal Medicine. Team members champion the innovative use of MIDD for efficient drug development and robust decision-making, offering a great environment for learning and professional growth. This role provides clinical pharmacology and MIDD expertise for clinical plans, project teams, and regulatory interactions, integrating knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and diseases for rational 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 on project teams.
- Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge for safe human administration and to establish predictive models prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level, including clinical development plan, PK/PD analyses, and PK/immunogenicity/biomarker 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 dosage regimens.
- Ensure appropriate design and implementation of End-to-End MIDD plan conforming with best practices.
- Ensure use of innovative analytical methods to integrate 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.
- 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
- 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 with 0+ years of industry experience.
- Pharm.D. or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline with 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.
- Breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers.
- Candidates must be authorized to be employed in the U.S. by any employer.
- U.S. work visa sponsorship is not available for this role now or in the future.
- This position requires permanent work authorization in the United States.
Skills
- Clinical Pharmacology
- MIDD (Model Informed Drug Discovery and Development)
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Quantitative skills
- Mechanistic PK/PD modeling
- Systems pharmacology
- Literature meta-analyses
- Population modeling
- Clinical trial simulations
- NONMEM
- R
- Communication skills
- Presentation skills
Location
- Hybrid
Work Type
- Hybrid
Experience Level
- 0+ years of industry experience (for MD/Ph.D.)
- 2+ years of industry experience (for PharmD)
Education Level
- M.D./Ph.D., or equivalent
- Pharm.D. or equivalent
Salary/Compensations
- $106,000.00 - $176,600.00
- Bonus target of 15.0% of base salary
- Eligibility for share-based long-term incentive program
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits (medical, prescription drug, dental, and vision coverage)
- Relocation assistance may be available
About the Company
- Pfizer is a leader in model informed drug discovery and development (MIDD), 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.
- 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.
