1+ months

Preclinical to Clinical Translation Lead

Pfizer
Cambridge, MA 02139
**ROLE SUMMARY**



Drug Safety R&D (DSRD) is a global organization that provides input into drug target selection, helps identify promising drug candidates, discover and develop biomarker and screening assays, and leads the conduct and interpretation of toxicology studies in support of clinical development programs. DSRD comprises a broad group of scientific disciplines including (but not limited to) pathology, toxicology (both regulatory and investigative), safety pharmacology, and safety biomarkers; each generating or supporting critical data types for analysis and decision-making in the drug development process. DSRD supports programs from five Pfizer Research Units comprising diverse treatment modalities (e.g., small molecules, biologics, gene therapy, vaccines) from Discovery through Registration.

Cross-species gap is a major hurdle for translational toxicology research yet systematic knowledge of species differences has not been understood. There is a need to quantitatively understand and model forward (preclinical to clinical) and reverse (clinical to preclinical) safety translation. Working with clinicians, statisticians, bioinformaticians and biological scientists from clinical, Research Units (RU) and DSRD, the Preclinical to Clinical Translation Lead will mine comprehensive preclinical data sets that can provide valuable insights and relationships between variables that confirm experimental intuition while establishing new ones. From a safety biomarker strategy standpoint, the lead will develop an understanding of which safety signals from clinical studies are effectively identified or missed in preclinical studies, develop quantitative capabilities to perform preclinical to clinical translational predictivity focused on safety endpoints. Lead will also enhance prospective molecular "omics" signature-based biomarker discovery platform and translation approaches by utilizing modelling and artificial intelligence approaches from within DSRD as well as innovate industry-leading capabilities.



**ROLE RESPONSIBILITIES**



+ Serve as Scientific Lead for preclinical to clinical safety quantitative biomarker efforts, including data integration, analytics, and management, and interface with DSRD's statistical modeling and machine learning (ML) groups.

+ Exploit preclinical data and clinical safety information for better prediction of potential human safety liabilities and to fine tune future preclinical in vivo safety strategies.

+ Lead cross-species efforts by evaluating rich set of internal biomarker observations in a robust manner and by supplementing this with externally available data sets.

+ In collaboration with scientific leadership across DSRD, ECD, and RUs, develop integrated preclinical/clinical datasets and perform appropriate analytics and modeling solutions for strategies areas of highest impact. Specific examples include understanding cardiovascular, hepatic, gastrointestinal, and hematologic risk translation from animals to humans.

+ Provide leadership in driving strategies for the use of machine learning approaches for discovering and developing novel safety biomarkers for target organs of high attrition (eg; Liver and vascular).

+ Develop predictive molecular signatures of safety biomarkers using multi-omics and single cell sequencing datasets and approaches by prospective and publicly available biomarker repositories by interfacing within DSRD and partner lines.

+ Partner with the DSRD Data Operations, Statistics, Computational Toxicology and other DSRD colleagues, perform the required data engineering, aggregation and curation necessary to support preclinical to clinical translational modeling work.

+ Partner across the multiple biomarker, computational/integrative biology, and digital technology groups will be critical to the success of the incumbent

+ Lead and/or influence external safety data translation initiatives such as IMI and IQ consortia

+ As a DSRD leader in this space, the Translational Lead will provide mentorship and develop key talent in data translation and modeling approaches thereby building future capacity and positioning Pfizer for external leadership



**BASIC QUALIFICATIONS**



+ PhD in Translation Science, Biochemistry, Toxicology, or Pharmacology

+ Minimum 15 years post-PhD with industry and/or academic relevant experience with a track record of scientific leadership identifying multidisciplinary solutions to complex data analytic problems

+ Demonstrated industry-leading strategic leadership

+ Leading edge knowledge of the drug development process, including drug target identification, lead optimization, preclinical safety and clinical development

+ Extensive understanding of external resources and initiatives in data analytics, bioinformatics and high-throughput biology as it pertains to drug safety

+ Extensive understanding of the clinical development process, including protocol design, and drafting and execution of statistical analysis plans

+ Proven track record in milestone-driven collaborative work with chemists, biologists, statisticians and other scientists involved in drug discovery/development

+ Strong oral and written communication skills

+ Demonstrated external influence through publications in a range of computational science disciplines, scientific presentations, and participation in industry-wide consortia.



**PREFERRED QUALIFICATIONS**



+ Experience applying modeling approaches to understanding preclinical and clinical outcomes from big and complex data sets

+ Advanced programming experience in R and/or Python

+ Track record of presenting complex/technical information to individuals from diverse backgrounds.

+ Demonstrated history of successfully collaborating in team environments.

+ Demonstrated ability to build and maintain strong relationships with scientists and leadership from diverse backgrounds

+ Experience with database design, development, management, and analysis (e.g., SQL and NOSQL)

+ Working knowledge of cloud computing (e.g., AWS), Linux clusters, and GPU's.

+ Working knowledge of the fundamental concepts of statistical approaches used in the traditional preclinical and clinical settings and experience in the design, testing, and validation of statistical models

+ Working knowledge of multiple disciplines and ideally pharmacology and toxicology.



**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 Package: yes

+ Eligible for Employee Referral Bonus: yes



\#LI-PFE

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Categories

Posted: 2019-10-02 Expires: 2020-02-05

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Preclinical to Clinical Translation Lead

Pfizer
Cambridge, MA 02139

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