1+ months

Preclinical to Clinical Translational Lead

Cambridge, MA 02139
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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.

Historically, there has been limited data-driven efforts and capabilities 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 Early Clinical Development (ECD), Research Units (RU) and DSRD, the Preclinical to Clinical Translation Lead will develop and enhance our internal laboratory and quantitative data capabilities to perform preclinical to clinical translational modeling focused primarily on safety endpoints. This position will lead and manage Pfizer's preclinical to clinical data integration from retrospectively generated data as well as enhance prospective "omics" based biomarkers discovery platform and translation approaches. The Lead will utilize statistical modeling and machine learning (ML) approaches from within DSRD as well as innovate industry-leading capabilities in this area. This position will also serve as the primary DSRD interface for all quantitative data-based nonclinical to clinical translational initiatives with ECD. The lead will also be expected to lead and/or influence external data translation consortia such as IMI and IQ initiatives.


+ Serve as Scientific Lead for preclinical to clinical efforts, including data integration, analytics, and management, and interface with DSRD's statistical modeling and machine learning (ML) groups. Working with DSRD, ECD, RU and other relevant lines, lead development of a preclinical to clinical translational modeling strategy in alignment with DSRD strategic objectives and other partners across WRDM and Pfizer.

+ In collaboration with scientific leadership across DSRD, ECD, and RUs, as well as business technology, medicinal chemistry, and ADME, develop integrated preclinical/clinical datasets and perform appropriate analytics and statistical modeling solutions for 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)and to enable forward (preclinical to clinical)and reverse (clinical to preclinical) translation.

+ Develop machine learning based predictive biomarkers using multi-omics and single cell sequencing datasets and approaches by interfacing within DSRD and partnerlines

+ Lead collaborations across and within disciplines (ECD, RUs and DSRD) and externally to validate the translational approaches using multi-site and multi-institutional preclinical and clinical datasets to generalize and implement the findings.

+ Benchmark with industry peers and develop industry-leading capabilities in understanding and predicting/modeling clinical translation.

+ Lead prioritization of translational modeling efforts by working with DSRD and ECD leadership.

+ 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.

+ Work with DSRD and ECD colleagues to develop strategic investments that enable broader and more generalized preclinical to clinical translation capabilities.

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

+ 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


+ Ph.D. in Computer Science, Statistics, Data Science, Genomics, Genetics, 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.

+ **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.**


+ Experience applying statistical modeling approaches to understanding preclinical and clinical outcomes from big and complex datasets

+ 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.

**Other Job Details:**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus


**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.

Research and Development
Posted: 2020-02-13 Expires: 2020-04-16

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Preclinical to Clinical Translational Lead

Cambridge, MA 02139

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