The candidate will be working in a team of scientists reporting to a group lead in San Diego supporting late stage oncology programs. The candidate will be a part of the Pfizer Oncology Clin Pharm team with approximately 30 scientists. We emphasize on the candidate's quantitative pharmacology skills, scientific reasoning, regulatory affairs skills, written and verbal communication skills, exploratory graphical analysis skills, study design and report writing skills.
The candidatewill act as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary study team for a late-stageimmuno-oncology program ROLE RESPONSIBILITIES
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."
- Act 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
- Responsible for providing 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 including Investigator Brochures, EOP2 meetings.
- Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
Other Job Details:
- A clinical pharmacologist with a PhD/PharmD and 4+ years of experience
- Abilityto apply pharmacokinetic and pharmacokinetic-pharmacodynamic concepts, includingmodeling and simulation to clinical trial design.
- Strong technical proficiency in pharmacokinetic software (e.g WinNonlin, NONMEM, S+Plus, R, etc.) is preferred.
- Proven record in clinical drug development with experience in oncology if preferred but not required.
- The ideal candidate will be an excellent communicator with strong interpersonal skills
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
- Eligible for Employee Referral Bonus
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