Associate Director / Director, Precision Medicine- Early Clinical Development
The Precision Medicine Clinical Biomarker Lead works collaboratively across clinical, technical, and research teams to define and operationalize early clinical biomarker strategies within a research unit portfolio. The Clinical Biomarker Lead will establish and coordinate interactions between clinical and research project teams, assay specialists, CRO’s, PM Clinical Biomarker Laboratories, and the internal biomarker community.
A successful candidate can coordinate and lead within a cross-disciplined, matrix team organization, multitask/prioritize multiple projects, and leverage existing information in order to deliver effective, fit for purpose biomarker strategies, quality data, and interpretation of biomarker results to drive early clinical development. In addition, the Clinical Biomarker Lead will present and share project status, issues, and learnings to all stakeholders to ensure a culture of transparency, innovation, and continuous improvement.
Collaborates with clinical, research, and partner line colleagues to develop and defend scientifically rigorous translational and exploratory biomarker strategies that assess signs of pharmacology, proof of mechanism, early signs of efficacy that enable proof of concept studies, and generate an understanding of the variability in patient response.
Assembles and leads collaborative biomarker sub-teams, made up of colleagues with relevant technical, research, or clinical expertise, to develop, refine, and operationalize biomarker strategy.
Participates in above asset initiatives such as phase 0 natural history and methodology studies to help expand and sustain the portfolio pipeline.
Ensures timely biomarker assay development, fit for purpose validation and resourcing.
Contributes clinical protocol, lab manual, and informed consent language specific to biomarkers.
Leverages external contract research organizations and vendors along with appropriate internal laboratories to execute biomarker analyses.
Serves on clinical operations teams to endure compliance around clinical biospecimen management and vendor oversight.
Ensures timely delivery of internally or externally generated biomarker data for analysis.
Works with biomarker and clinical teams to interpret biomarker results in the context of the clinical study.
Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.
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.
PhD with minimum of 5+ years of experience in the early clinical drug development space. Industry experience in drug discovery early development strongly preferred.
Experience in clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, analytical and clinical validation of biomarker assays, and/or vendor interactions required.
Candidate should have a good working knowledge of the application of biomarker technologies (eg. flow cytometry, ligand binding assays, mass spectrometry) as well as high dimensional exploratory platforms (eg. transcriptomic, proteomic, metabolomics).
Background in metabolic, cardiovascular, rare genetic, or inflammatory diseases preferred.
Demonstrated experience in leading matrix teams made up of clinical, technical, and research colleagues.
Builds connections and leverages expertise by developing positive, collaborative partnerships.
Strong track record of problem-solving, risk mitigation, and issues-management in a matrix environment.
Demonstrated ability to manage, prioritize, and contribute to multiple projects at once.
Highly effective verbal and written communication skills.
Other Job Details
Eligible for Relocation Package
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