Associate Director, Clinical Pharmacology Lead

Pfizer • Cambridge, MA

2d • Hybrid

About The Position

Exciting opportunity in Clinical Pharmacology! Our Clinical Pharmacology Team is looking for an Associate Director 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! ROLE SUMMARY: Clinical Pharmacology Lead (Associate Director) 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.

Requirements

• 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.
• Intimate knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration.
• 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.).
• Excellent written and verbal communication skills.
• Demonstrated presentation skills.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
• This position requires permanent work authorization in the United States.

Responsibilities

• Act as Clinical Pharmacology representative on Clinical Sub Team and 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.
• 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.
• 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.
• 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.
• Provide End-to-End clinical pharmacology contribution to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.).
• Develop new methodologies through internal and/or external collaborations with world leading experts.
• Coach less experienced colleagues and team members.
• Stay abreast of literature, regulatory guidelines, and internal guidance and SOPs.
• Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium.

Benefits

• In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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. 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree