Associate Director, Clinical Pharmacology Lead
Pfizer
8 hours ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
ROLE RESPONSIBILITIES:
- Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team and other multifunctional teams as appropriate.
- Provide expertise, leadership, and clinical pharmacology deliverables for assigned projects.
- Design and execute clinical pharmacology plans; implement clinical pharmacology best practices.
- Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge to support safe human administration and establish predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, PK/PD analyses, 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 achieve optimal doses/dosage regimens in patients.
- Ensure design and implementation of an End-to-End MIDD plan that conforms 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 contributions to regulatory documents (e.g., briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA).
- Develop new methodologies through internal and/or external collaborations.
- Coach less experienced colleagues and team members.
- Stay abreast of literature, regulatory guidelines, internal guidance, and SOPs.
- Influence external environment through publications, presentations, and representation at scientific societies/industrial consortium.
BASIC QUALIFICATIONS:
- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- 1+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.
- Knowledge of drug development; experience applying quantitative pharmacology approaches for knowledge integration.
- Strong quantitative skills (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.).
- Excellent written and verbal communication skills.
- Demonstrated presentation skills.
- Breadth of leadership experience (influencing/collaborating, developing/coaching others, and guiding work to achieve meaningful outcomes and business impact).
WORK LOCATION / APPLICATION INSTRUCTIONS:
- Hybrid role; live within commuting distance; average 2.5 days/week on-site or more as needed.
- Last date to apply: April 20, 2026.
- Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team and other multifunctional teams as appropriate.
- Provide expertise, leadership, and clinical pharmacology deliverables for assigned projects.
- Design and execute clinical pharmacology plans; implement clinical pharmacology best practices.
- Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge to support safe human administration and establish predictive model structure prior to FIH.
- Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, PK/PD analyses, 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 achieve optimal doses/dosage regimens in patients.
- Ensure design and implementation of an End-to-End MIDD plan that conforms 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 contributions to regulatory documents (e.g., briefing documents, regulatory queries, Investigator’s Brochures, IND, NDA/MAA).
- Develop new methodologies through internal and/or external collaborations.
- Coach less experienced colleagues and team members.
- Stay abreast of literature, regulatory guidelines, internal guidance, and SOPs.
- Influence external environment through publications, presentations, and representation at scientific societies/industrial consortium.
BASIC QUALIFICATIONS:
- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- 1+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.
- Knowledge of drug development; experience applying quantitative pharmacology approaches for knowledge integration.
- Strong quantitative skills (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.).
- Excellent written and verbal communication skills.
- Demonstrated presentation skills.
- Breadth of leadership experience (influencing/collaborating, developing/coaching others, and guiding work to achieve meaningful outcomes and business impact).
WORK LOCATION / APPLICATION INSTRUCTIONS:
- Hybrid role; live within commuting distance; average 2.5 days/week on-site or more as needed.
- Last date to apply: April 20, 2026.