Pfizer Clinical Pharmacology Lead (Sr. Manager) in La Jolla, California
Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of oncology drugs. It is exciting, critical work and you could be part of it. Pfizer is a leader in Model Based Drug Development. We have an open position as Sr. Manager, Clinical Pharmacology in Early Oncology Development and Clinical Research, Oncology R&D, in La Jolla, CA. The ideal candidate embraces model-based drug development - constructs, validates, and utilizes disease, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with other Oncology R&D, PDM and TO partners. Clinical Pharmacology Leads are also responsible for planning and directing clinical pharmacology components of clinical programs (including early clinical development plan/POC) and studies (including protocol preparation and reporting).
• Accountable and responsible for the clinical pharmacology deliverables for the assigned projects within sphere of influence.
• Responsible for appropriate clinical pharmacology input on project teams and contribution of clinical pharmacology expertise and leadership to a project.
• Responsible for ensuring planning and direction of clinical pharmacology components on the clinical project level (including clinical development plan) and studies (including synopsis preparation, clinical phase oversight, reporting).
• Responsible for implementing clinical pharmacology best practices on project team.
• Responsible for ensuring clinical pharmacology leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies.
• Responsible (with clinicians and statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients.
• Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan that conforms with best practices.
• Responsible for ensuring use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
• Responsible for ensuring appropriate summary and interpreting results of pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs.
• During the pre-clinical stages of drug development, works closely with colleagues in 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.
• Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) for human studies.
• Provides clinical pharmacology support and leadership in various regulatory interactions.
• Influences environment outside of Pfizer through methods such as publication and presentations.
• A PhD or MD/PhD in Pharmacology or related scientific field in combination with relevant experience
• 5+ years of relevant industry experience
Clinical Pharmacology: demonstrates thorough understanding of the following: 1) principles of PK, PK/PD and pharmacology relevant to drug candidates; 2) knowledge of phase I studies including design and interpretation 3) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics 4) quantitative modeling and simulation skills and the application of these approaches to drug discovery and development.
• Communication Skills: demonstrates ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form; demonstrates ability to write clinical pharmacology results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.
• Scientific Excellence: demonstrates understanding of the complexities and recent developments in clinical pharmacology and the implications for drug development.
• Regulatory Knowledge: understands and is able to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies.
- A PhD in Pharmacology/Pharmacy/Biological Sciences with hands on quantitative skills
EEO & Employment Eligibility
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Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.