You will be responsible for driving and leveraging preclinical knowledge of novel investigational agents to successfully translate our understanding of tumor biology and immunology into competitive clinical therapeutic development strategies. You will combine a deep understanding of cancer mechanisms with expertise in biospecimen analysis (preclinical models through Phase 1 Trials). Design and execution of clinical translational MoA/POC studies will inform drug development decisions that facilitate forward and reverse translational learning.
You will identify preclinical program MoA gaps/risks and will utilize actionable data from preclinical models to address the clinical development plan strategy. You will lead the analysis of human patient specimens from clinical studies using state of the art platforms and novel technologies and external collaborative partnerships that will leverage primary/secondary MoAs, review of safety biomarkers, and inform patient stratification strategies to increase positive outcomes in early clinical development. Investigation into mechanism of response and resistance will prioritize new indications for therapeutic candidates. Further, these efforts will identify target patient populations with additional focus applied to pharmacodynamic assessments of target engagement and PK/PD relationships, enabling dose-finding decisions and providing data for rational combination designs.Primary Duties:
- Accountable for the development of scientifically rigorous preclinical and clinical translational research strategies that assess Proof Mechanism, establish early Signs of Efficacy, illuminate mechanisms of resistance, and drive combinations.
- Work closely with in vivo pharmacology to capture translational understanding in animal models that can translate to clinical investigation.
- Translational biology functional lead for experimental therapeutics programs to represent molecule teams at internal governance reviews.
- Partner collaboratively across integrated, multi-functional clinical program teams encompassing development (e.g. preclinical modelling, clinical, clinical pharmacology, statistics, development operations) and research (e.g. close interactions with biology and computational scientists), clinical biomarker assay specialists, diagnostics and research program/asset leaders.
- Analyze, interpret and report results of clinical biomarker analyses, including support of regulatory filings, and serve as Translational expert at program team interactions with Health Authorities (HA).
- Innovate with academic collaborators to expand clinical translational research; participate in advisory boards as needed.
- Work with external contract research organizations and vendors to execute biomarker analyses
- Support development of companion diagnostic tests as needed.
- Ensure a close relationship and partnership with internal/external colleagues while upholding an enterprise and patient mindset and fostering a culture of scientific excellence and innovation.
- Advanced degree (e.g. PhD, MD, MD/PhD, Pharm. D.), with focus on cancer biology and/or immunology and a minimum of 3 years of experience in oncology drug discovery and development.
- Advanced understanding of modern cancer biology, multi-omics and immuno-oncology in translational research ph 1 and 2 clinical trials.
- Understanding of preclinical modelling that can inform clinical development plan (CDP) evolution.
- Design, execution and interpreting cancer biomarkers studies in preclinical modelling and clinical trials, including biomarker development, validation and clinical application.
- Drive effective interactions at the interface between lab bench-based research and early clinical development up to proof of concept studies.
- Strong publication track record of primary research in high-quality, peer-reviewed journals.
- Experience building collaborations that drive scientific advances.
- Experience with clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, analytical and clinical validation of biomarker assays, and vendor interactions.
- Experience leveraging genomic and molecular information from patients with extraordinary responses in early-stage clinical trials to guide clinical development.
- Direct experience and/or familiarity with novel technologies applicable to cancer biomarker and/or immune response analysis (e.g. next-generation sequencing, immunohistochemistry, immunofluorescence, flow cytometry, gene expression profiling, or digital image analysis).
- Experience with multiple modalities (e.g. small molecules, nanoparticles, antibodies, antibody-drug conjugates, bispecific antibodies).
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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