Clinical Pharmacology Lead (Manager)

Pfizer; Pennsylvania; Hybrid; USD 106,000 - 177,000; Full time

Benefits offered by this job

401(k) matching

Vacation & holidays

Parental leave

Health benefits

Job summary

Pfizer is seeking a Clinical Pharmacology Lead to support the End-to-End Internal Medicine portfolio. The role centers on providing clinical pharmacology and MIDD input to project teams and regulatory interactions, shaping dose selection, study design, and regimen choices.

The candidate will integrate PK/PD knowledge with patient characteristics and diseases to drive rational development strategies and ensure efficient decision-making in multi-disciplinary teams.

Qualifications

• Strong quantitative skills with experience in PK/PD modeling, literature meta-analyses, population modeling, and trial simulations (NONMEM, R).
• MD/PhD or PharmD-level training with industry experience in pharmacokinetics/pharmacometrics, clinical pharmacology, or related discipline.

Responsibilities

• Act as Clinical Pharmacology representative on sub-teams and development teams.
• Provide expertise, leadership, and deliverables for clinical pharmacology across projects.
• Design and execute clinical pharmacology plans and implement best practices.

Skills

Quantitative skills

Pharmacokinetics

Pharmacometry

Nonlinear mixed effects

Communication skills

Leadership

Education

MD/PhD or equivalent

PharmD or equivalent

Job description

Role Summary

Exciting opportunity in Clinical Pharmacology! Our Clinical Pharmacology Team is looking for a Manager to support the exciting portfolio in Internal Medicine. Our team members champion the innovative use of MIDD for efficient drug development and robust decision-making. A great environment for learning and professional growth! Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of drugs. Pfizer is a leader in model informed drug discovery and development (MIDD), and we are expanding in influence and impact. We have an open position as Clinical Pharmacology Lead supporting our End-to-End Internal Medicine portfolio. The ideal candidate is responsible for providing the clinical pharmacology and MIDD components of clinical plans and provide clinical pharmacology expertise to the project team and regulatory interactions. Working with multifunctional study team, Clinical Pharmacology Leads utilize innovative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections.

Role 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.

Qualifications

• Strong quantitative skills and expertise (e.g. experience in mechanistic PK/PD modeling/systemspharmacology, 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 Employee Referral Bonus: YES
• Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed.

Compensation and Benefits

The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for 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. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.

• 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

Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Sunshine Act

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EEO & Employment Eligibility

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.

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