Clinical Pharmacology Lead

• United States - Massachusetts - Cambridge

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place. To fully realize Pfizer's purpose - Breakthroughs that change patients' lives - we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Exciting opportunity in Clinical Pharmacology! Our Clinical Pharmacology Team is looking for an Manager or Associate Director to support the exciting portfolio in Inflammation & Immunology . 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!

Clinical Pharmacology Lead (Manager or Associate Director)

ROLE SUMMARY: Clinical Pharmacology

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 Inflammation & Immunology 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 and Development Team as appropriate.
• Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence.
• Responsible for designing and executing clinical pharmacology plans and implementing 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 ensuring planning and direction of clinical pharmacology components at the project level (including clinical development plan) and studies (including synopsis preparation, clinical phase oversight, reporting)
• Responsible for ensuring clinical pharmacology leadership of multifunctional study team to design, deliver and report clinical pharmacology studies and ensuring overall scientific accountability
• 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
• Responsible for ensuring appropriate summary and interpreting results of PK/PD analyses with respect to their impact on development and clinical use of drugs.
• Accountable for ensuring that there are valid methods for measuring drug concentration, relevant biochemical biomarkers, and immunogenicity (e.g., ADA/NAb) for clinical studies.
• 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 CPLs and team members from other disciplines.
• Stay abreast of literature, regulatory guidelines, and internal guidance on clinical trial conduct, including internal SOPs and regulations to be a team resource of clinical pharmacology knowledge in terms of both medical background and clinical trial design.
• Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium.

QUALIFICATIONS:

• 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.
• 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.).
• Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
• Intimate knowledge of the drug development and experience in applying quantitative pharmacology approaches to knowledge integration.
• 0+ years of industry experience for Manager and 1+ years of industry experience for Associate Director in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.
• Excellent written and verbal communication skills.
• Demonstrated presentation skills

Other Job Details:

• Eligible for Relocation Package: YES
• Eligible for Employee Referral Bonus: YES
• Work Location Assignment: Hybrid

ROLE SUMMARY

Exciting opportunity in Clinical Pharmacology! Our Clinical Pharmacology Team is looking for an Manager or Associate Director to support the exciting portfolio in Inflammation & Immunology . 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!

Clinical Pharmacology Lead (Manager or Associate Director)

ROLE SUMMARY: Clinical Pharmacology

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 Inflammation & Immunology 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 and Development Team as appropriate.
• Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence.
• Responsible for designing and executing clinical pharmacology plans and implementing 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 ensuring planning and direction of clinical pharmacology components at the project level (including clinical development plan) and studies (including synopsis preparation, clinical phase oversight, reporting)
• Responsible for ensuring clinical pharmacology leadership of multifunctional study team to design, deliver and report clinical pharmacology studies and ensuring overall scientific accountability
• 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
• Responsible for ensuring appropriate summary and interpreting results of PK/PD analyses with respect to their impact on development and clinical use of drugs.
• Accountable for ensuring that there are valid methods for measuring drug concentration, relevant biochemical biomarkers, and immunogenicity (e.g., ADA/NAb) for clinical studies.
• 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 CPLs and team members from other disciplines.
• Stay abreast of literature . click apply for full job details