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Associate Director, Clinical Pharmacology
1 month ago
- Serve as Clinical Pharmacology representative on Clinical Sub Team and Development Team as appropriate.
- Participate in implementing model-based drug development using quantitative approaches to address complex questions arising during drug development
- Provide the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team including plan, design and oversee clinical pharmacology studies with operational assistance from operations colleagues
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc.
- Directs the planning of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics (as relevant).
- Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation.
- Leads clinical pharmacology contributions to all regulatory documents and interactions.
- Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
- PhD or PharmD
- 3+ years of related experience
- Experience applying pharmacokinetic and pharmacokinetic-pharmacodynamic concepts, including modeling and simulation to clinical trial design.
- Clinical drug development experience in oncology or other therapeutic area
- Strong communication skills--written, verbal and presentation
- Strong technical proficiency with pharmacokinetic software (e.g., WinNonlin, NONMEM, S+Plus, R)
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Associate Director, Clinical Pharmacology
6 days ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY: You will join a team of scientists supporting oncology clinical development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team for oncologyprograms. ROLE RESPONSIBILITIES: Represent Clinical Pharmacology on Clinical Sub Team and Development Team. ...
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Associate Director, Clinical Pharmacology
1 month ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY:You will join a team of scientists supporting oncology clinical development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team for oncologyprograms.ROLE RESPONSIBILITIES:Serve as Clinical Pharmacology representative on Clinical Sub Team and Development Team...
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Manager, Clinical Pharmacology
2 months ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARYWill join a team of scientists supporting oncology development programs. Will be the Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team of an oncology program.ROLE RESPONSIBILITIES Acts as Clinical Pharmacology representative on Clinical Sub Team and Development Team, as appropriate.Provides...
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Manager, Clinical Pharmacology
1 month ago
La Jolla, California, United States Pfizer Full timePOSITION SUMMARYYou will join a team of scientists supporting oncology development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team of an oncology program.ROLE RESPONSIBILITIES Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team as...
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Scientist, Tumor Biology Pharmacology
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Senior Scientist, Tumor Biology Pharmacology
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Executive Director, Global Development Lead
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Associate Director, Biostatistics
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Associate Director, Biostatistics
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La Jolla, California, United States Pfizer Full timeThe Senior Medical Director provides Clinical Development leadership and expertise on clinical trials directly and/or supervises other (associate) medical directors, including overseeing study design, conduct, and analysis. The senior medical director works closely with other functions such as clinical operations, biostatistics, pharmacovigilance, regulatory...
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Principal Scientist
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La Jolla, California, United States Pfizer Full timeROLE SUMMARYThe Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiological study execution ensuring consistency of approach, conduct, result reporting and oversight of core team activities within one or more specialty or primary asset programs. In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs...
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RN Clinic
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Clinical Study Team Lead
1 month ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY Why Patients Need You Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety...