ROLE SUMMARYIn research and development at Pfizer, model informed drug development (MIDD) plays an important role in understanding drug safety and efficacy. As a pharmacometrician, you will work with multidisciplinary teams where you will use quantitative methods to provide context on study results and answer team questions during clinical drug development. While your primary therapeutic area will include cardiovascular and metabolic diseases, you may have opportunities to work on projects outside these areas. Your work will directly support decisions during drug development and ultimately contribute toward delivering breakthroughs that change patients' lives.JOB RESPONSIBILITIES
Responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta analysis, quantitative knowledge management, decision analysis, and MIDD strategy in collaboration with partners.
With guidance, provide MIDD expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians, and statisticians, and other scientists to create MIDD plans that include assessments of a drug's efficacy, safety, and commercial viability.
Prepares formal presentations and written reports to Pfizer standards.
Author, contribute, and perform technical quality control checks for regulatory documents (modeling reports, summary documents, briefing books, regulatory responses).
Stays abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD, including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge and applications.
Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
May train, develop, and mentor less experienced pharmacometricians or other colleagues in systems pharmacology, clinical pharmacology or translational clinical sciences.
Contribute to pharmacometrics' ability to act as a conduit for cross learnings within/across the clinical development organizations. Promote, educate, and mentor others in application of quantitative techniques, best practices, MIDD, and share experiences through appropriate local and global discussions.
QUALIFICATIONS / SKILLSBasic Qualifications:
PhD, PharmD, or equivalent, including expertise in one or more areas (e.g., pharmacometrics, clinical pharmacology, pharmacokinetics, pharmaceutical sciences, biostatistics, applied mathematics, or related discipline).
0 to 4 years' experience in the quantitative field
Strong science and quantitative analysis background, with good working knowledge of pharmacokinetics, pharmacology, pharmaceutics, and/or statistics.
Basic understanding/knowledge of biology, physiology/pathophysiology, and drug research & development process
Experience using R and NONMEM (or equivalent software, e.g. Monolix, nlmixr2, Pumas)
Good communication skills (written, oral presentation)
Candidates from alternative backgrounds (e.g., mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.
Preferred Qualifications:
Industry or regulatory experience in pharmacometrics, clinical PK/PD, clinical pharmacology, or systems pharmacology.
Other relevant software experience (e.g. PsN, mrgsolve, LaTeX, Rmarkdown, Stan)
Experience in clinical trial simulation, machine learning, biostatistics, Bayesian methods, or literature meta-analyses/model-based meta-analyses
Candidates with significant (3-5 years) experience will also be considered. Position role and title (e.g. Associate Director) will be commensurate with type and years of experience.
ORGANIZATIONAL RELATIONSHIP
Reports to Internal Medicine Pharmacometrics Group Leader within the line organization of Pharmacometrics and Systems Pharmacology, Translational Clinical Sciences
Matrixed relationships particularly with clinical pharmacology leads, clinicians, statisticians, colleagues from programming groups and other groups as required
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to travel for business as necessary
Availability for business meetings in the US Eastern Time Zone
Relocation support availableWork Location Assignment: HybridThe annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer 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 EligibilityPfizer 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.Medical#LI-PFE
