Posted:
8/7/2024, 5:00:00 PM
Location(s):
California, United States ⋅ San Diego, California, United States ⋅ Washington, United States ⋅ South San Francisco, California, United States ⋅ Bothell, Washington, United States
Experience Level(s):
Senior
Field(s):
Medical, Clinical & Veterinary
ROLE 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 oncology programs.
ROLE RESPONSIBILITIES:
Represent Clinical Pharmacology on Clinical Sub Team and Development Team.
Participate in the implementation of model based drug development using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase II results.
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
Serve as an expert on the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.
Coordinate with Medical Writers (and other team members) in the data review, analysis and reporting of the CP study. Share responsibility with Medical Writer, for overall content and accuracy of study report before forwarding for final sign-off.
Responsible and accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and meta-analysis.
Directs the planning of all relevant PK-PD analyses. Use 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).
Provide 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.
Provide Clinical Pharmacology expertise to Discovery during the pre-clinical stages of drug development and works with Research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration.
Ensure that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic.
Participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
As necessary, act as clinician for Phase I studies or clinical lead / research project lead for specific drug development projects.
QUALIFICATIONS
Must Have
PhD or PharmD
4+ 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
Nice To Have
Strong technical proficiency with pharmacokinetic software (e.g., WinNonlin, NONMEM, S+Plus, R)
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.
Relocation support available
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine