Groton, CT, United States
Biotech, Sciences, Pharmaceutical
Apr 10, 2021
Jul 24, 2021
The Head of Clinical Biomarker Technologies (CBT) manages the clinical biomarker labs in Precision Medicine. The labs include flow cytometry, mass spectrometry and ligand binding groups. The head of clinical biomarker labs is accountable for biomarker bioanalytical support for the WRDM clinical portfolio emphasizing the development of proof of mechanism and patient stratification assays. The Head of clinical biomarker technologies works with stakeholders to develop clinically compliant GCLP/GCP assays for Pfizer clinical trials. The head also partners with Pfizer Phase I clinical units and full development clinical assay groups to complete clinical sample analysis internally when needed and to coordinate technical transfers of assays to third party vendors. The Head of CBT also works with key stakeholders on biomarkers for investigator lead Pfizer clinical research collaborations and on regulatory guidance for emerging new technologies.
The individual will supervise a group of lab heads of flow cytometry, mass spectrometry and ligand binding and scientists within the labs.
The individual is accountable for regulatory compliance of the related bioanalytical support (both preclinical and clinical) and internal/external regulatory audit activities as required.
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 lead will work closely with clinical teams as subject matter experts on biomarker assay technologies and provide feedback and support for study teams and regulatory interactions.
The lead will initiate and develop constructive relationships across ECD, Research Units, Medicine Design, Safety, Global Product Development, Phase I units, Commercial 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.
PhD, MD, MD/PhD and/or PharmD preferred . MS considered if 8 experience and demonstrated leadership skills.
8 years of experience in pharmaceutical discovery and/or exploratory clinical research
Background and applied experience in regulated and non-regulated biomarker technologies including, proteomics, mass spectrometry, ligand binding immunoassays, westerns, enzyme assays and flow cytometry.
Experience working with cross-functional clinical study teams to deliver asset and platform specific translational biomarker strategies.
Experience identifying multidisciplinary biomarker solutions for supporting portfolio milestones (e.g. POM/SOCA/POC) and 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 broad range of biomarker 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
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
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.
Must be physically capable of working in a laboratory environment
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel with transit between Groton and Cambridge sites
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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EEO & Employment Eligibility
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Research and Development
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