1+ months

Director, Pharmacometrician

Pfizer
Collegeville, PA 19426
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**JOB SUMMARY**



+ Provides pharmacometric expertise and leadership to projects.

+ Develops model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.

+ Conducts and reports quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.

+ Identifies opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety.

+ Acts as pharmacometric Subject Matter Expert (SME), including proactive support and development of quantitative methodology, software, hardware, and related business processes, in addition to training to the the global clinical pharmacology organization.



**JOB RESPONSIBILITIES**



+ Contributes to MIDD, complementary to Pfizer processes, including Enhanced Quantitative Drug Development (EQDD) and Enhanced Clinical Trial Design (ECTD).

+ 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 EQDD strategy in collaboration with partners.

+ Prepares formal presentations and written reports to Pfizer standards.

+ Contributes with project teams/partners to regulatory responses, briefing documents, submissions, or other regulatory documents and/or presentations.

+ 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.

+ Contributes 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.

+ Produces and presents quality scientific papers at external meetings and for publication.

+ Contribute or lead 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 participate in and contribute to global computational sciences community of practice, and contribute to business requirements/support of IT colleagues/contractors, systems and tools to ensure support services to systems and software tools and colleagues are best in class.Produces and presents quality scientific papers at external meetings and for publication.

+ Prepares and delivers training on quantitative tools, methodologies, software, hardware, and related business processes internally to Pharmacometricians and for the global clinical pharmacology organization.

+ May train, develop, and mentor less experienced Pharmacometricians or other clinical pharmacology colleagues.

+ May organize and manage project deliverables utilizing the appropriate expertise and resources (internally within the company and/or externally within consultant groups and academic institutions).

+ May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.

+ May collaborate with, enable and influence external key opinion leaders and regulatory authorities in best practices for drug development science.



**QUALIFICATIONS / SKILLS**



+ An interest and experience of pharmacostatistical methods of data analysis and study design are essential.

+ Ideal qualifications include M.S., Pharm.D, PhD or equivalent degree with training and/or expertise in one or more areas related to pharmacostatistical modeling (e.g., pharmacometrics, pharmacokinetics, clinical pharmacology, statistics, or related discipline).

+ Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.



**Attributes:**



+ 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

+ Good computational skills.

+ Good knowledge of a range of MIDD software (R, NONMEM, STAN, etc.).

+ Good communication skills (written, oral presentation).

+ Balance multiple responsibilities, projects and teams simultaneously.

+ Adapt and be dynamic.

+ Identify and understand relevant scientific literature and apply knowledge gained from these sources.

+ Identify/develop and apply new quantitative methods as needed to solve problems in pharmaceutical research.

+ Interpret a range of model types and identify scientific, technical and methodology strengths and weaknesses.



**Competency**



+ demonstrates thorough understanding, and application, of quantitative modeling and simulation principles.

+ Communication Skills: demonstrates excellent verbal and written communication skills.



**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.



**Other Job Details:**



+ Eligible for Relocation PackageEligible for Employee Referral Bonus



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-08-01 Expires: 2019-11-04

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Director, Pharmacometrician

Pfizer
Collegeville, PA 19426

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