Head Clinical Pharmacogenomics

ROLE SUMMARY

The Head of Clinical Pharmacogenomics (PGx) in Precision Medicine leads both the CLIA ADME genotyping lab focused on understanding patient drug-drug interaction risk of Pfizer compounds and the clinical next generation sequencing lab that supports compound proof of mechanism and disease understanding in WRDM studies. The Head of Clinical PGx is an internally and externally acknowledged scientific expert in pharmacogenomics and genomic biomarker assay development, method validation and study support of translational and clinical biomarker assets. This role has expert working knowledge of genetic and genomic bioanalytical methodologies, sample extraction/isolation techniques, gene and vaccine technologies for viral load/vector shedding/stable integration and bioinformatic knowledge for downstream analysis. This role oversees the Clinical Pharmacogenomics Laboratory and provides supervision of laboratory staff, responsible for colleague training, guiding project support, performance management, technical/scientific supervision, data QC review, approval and compliance oversight. The Head of PGx works closely with the Oncology Clinical Genomics lab to harmonize on clinical genomic assay validation and reporting. This individual will need to lead cross-functional teams and partner with multiple lines in WRDM and GPD to ensure best practice is used in the application of genomic technologies and in supporting regulatory documentation. A broad understanding of genomic technologies in drug development is critical.

• The individual will supervise both the CLIA regulated ADME genetics lab and Groton based next generation sequencing labs.
• Individual harmonizes with Oncology clinical NGS labs on SOPs, compliance and reporting.
• The individual is accountable for regulatory compliance of sample handling, assay validation and analysis (both preclinical and clinical) as well as internal/external regulatory audit activities including FDA audits.
• The individual will be partnering with multiple partner lines as well as RU PI's and leaders, BU's, CAG, and other cross line cross sites and organizations and supporting internal and external collaborations.
• The individual will ensure that bioanalytical assays are developed and validated on time and per departmental SOPs and that regulatory compliance is maintained during support of regulated studies as appropriate. This position will demonstrate the ability to build high performance teams where technical excellence, empowerment, career development and leadership at all levels is expected and fostered. This individual will oversee the regulatory structure and compliance within the regulated laboratories to meet expectations for the development and implementation of clinical biomarkers.

• The head of clinical PGx will work closely with clinical teams as subject matter experts on genomic biomarker assay technologies and provide feedback and support for study teams and regulatory interactions.
• The head will initiate and develop constructive relationships across ECD, Research Units, Medicine Design, Safety, Global Product Development, Phase I units, Commercial, CMC and Regulatory functional lines to ensure seamless execution of portfolio translational medicine strategies. The lead co-chairs cross-functional teams and influences at a worldwide corporate global level.
• The Head leads across the internal Pfizer and external matrix to apply high density genomic data to support portfolio metrics (e.g. POM/SOCA/patients stratification) and to monitor and apply new genomics technologies for partner lines (e.g. Pharm Sci that require as part of new CMC requirements for GMOs).
• The head of clinical PGx will work with WRDM and GPD cross-functional lines to develop strategic risk mitigation testing plans for genetically modified organisms (GMO) gene therapy programs and work with external Pharma partners on driving an aligned guidance on GMO monitoring strategies.

BASIC QUALIFICATIONS

Education

• PhD, MD, MD/PhD and/or PharmD preferred . MS considered if 8+ experience and demonstrated leadership skills.

Primary

• 8+ years of experience in pharmaceutical discovery and/or exploratory clinical research
• Background and applied experience in regulated and non-regulated clinical genetic and genomic technologies including,.
• Experience working with cross-functional clinical study teams to deliver asset and platform specific translational biomarker strategies.
• Experience identifying genomic solutions for supporting portfolio milestones (e.g. POM/SOCA/POC), CMC support for GTx and able to troubleshoot in ambiguous situations across business lines where the risk is high and success uncertain.
• Able to work cross-functionally to develop solutions to complex translational issues within and beyond category area expertise.
• Demonstrated leadership skills in a rapidly changing organizational environment with many diverse stakeholders
• Demonstrated team-building, relationship-management, negotiating and talent management skills
• Excellent written and communication skills
• Working knowledge of a cutting edge genomic technologies and an understanding of validation requirements, implementation into clinical trials and interpretation of multivariate/high density biomarker data
• Solid track record of effectively working and communicating in a fast-paced environment with multi-disciplinary scientists, researchers and non-scientists, both internally and externally
• Good external presence and network, with a solid track record of scientific publications, external presentations, and effective external collaborations. A recognized subject matter expert in the field.
• Good understanding of business processes and decision making across the pharmaceutical R&D continuum, but especially in discovery and human exploratory research
• Good executive presence, with a demonstrated ability to influence senior internal and external leaders through all forms of communication
• Demonstrated proactive leadership in identifying and championing new initiatives with broad impact in the external scientific community, e.g., through steering committees, conference organization committees or editorial board memberships

The Head of the Clinical Pharmacogenomics reports to the Head of Precision Medicine, VP in early clinical development and serves on the Precision Medicine Leadership team. The Head of the Clinical PGx works closely with other PM functional lines including Head of the Biobank, Head of the Clinical Biomarker Technology Labs and Head of the Biomarker Leads. In addition, the Head of PGx works closely with the Head of Translational Oncology and Clinical Oncology NGS lab to harmonize on clinical genetic and genomics best practice, SOPs, data sharing and data reporting. PM is represented on the WRDM leadership team by the SVP of Early Clinical development. The Head of Clinical PGx interacts with many cross-functional teams from research units, Biomedicine and Medicine design, drug safety research and development as well as early clinical development lines (Clinical pharmacology, statistics, clinical scientists and digital and translational imaging and statistics). Interaction with full development teams is also critical (regulatory, medical commercial etc)

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.

PHYSICAL/MENTAL REQUIREMENTS

• Must be physically capable of working in a laboratory environment

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel between Pfizer sites

Relocation support available

Other Job Details:

• Eligible for Relocation Package
• Eligible for Employee Referral Bonus
• #LI-PFE

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Research and Development