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
- Eligible for Employee Referral Bonus
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.