The Director, Translational Biomarker Lead will lead a team dedicated to delivering translational and biomarker strategies for the TME TRC portfolio of Oncology/Immuno-Oncology programs. The Lead will bring deep scientific experience with emphasis on Oncology/Immuno-Oncology biomarkers, in depth knowledge of oncology, & clinical development perspective, and expertise in matrix-based management. The Lead will integrate translational research and clinical development, be responsible for the design, delivery, and execution of biomarker and translational strategies from program inception through First in Human, including initial patient selection pharmacodynamic endpoints and pharmacodynamic (proximal and distal), stratification strategies, in alignment with clinical development objectives, as well as clinic-ready target engagement and pharmacodynamics biomarker assays for TME TRC programs.
- Establish and execute well-crafted translational and biomarker strategy for all development candidates within the TME TRC, focused on clinic-ready patient selection, target engagement and pharmacodynamic biomarker assays.
- Lead a team of 3 PhD level, program biomarker leads, effectively partnering within a highly matrixed organization, and acting as the key interface between groups including discovery biotherapeutics, translational medicine, early clinical development and project leadership, and also with external partners, to deliver on the high-quality biomarker plans for all development candidate programs within the TRC.
- Accountable for scientific input and review into all biomarker aspects of early and late clinical development plans, clinical study reports and regulatory documentation and responses.
- Integrates translational research and clinical development, develops a biomarker strategy in alignment with clinical development objectives and leads efforts for data generation, & interpretation and communication to the development teams.
- Proactively provide insight into novel ways to incorporate biomarkers into clinical designs, including providing insight into new technologies to support biomarker plans, to enable early understanding of emerging drug profiles as programs emerging from the TRC move through early clinical development.
- Ensures the output of the biomarker plans meets established program standards (within budget, on schedule, compliance, etc.), while also looking for opportunities to streamline progress without compromising quality, making sure that Translational Development Team is focused on key assets and plans are integrated with broader Translational strategy.
- Communicates key biomarker program information, risks, and milestones, and manage information flow across key stakeholders including therapeutic area leadership, functional leads and team members, iindependently engages with development teams and technical/scientific experts to define, revise and progress biomarker plans.
- Collaborate and strategize across the entire Oncology organization to improve efficiency and accelerate the product pipeline forward.
- Contributes to due diligence efforts relating to technical, asset acquisition.
- MD, PhD or MD/PhD or equivalent advanced biology degree with 12+ years of relevant industry experience in oncology drug discovery and development process, preferred within translational biomarker roles.
- Documented experience in oncology/immuno-oncology drug development ), deep understanding of the role of translational research/medicine and clinical biomarkers in drug development, and working knowledge of all functional areas of drug development, including biology, clinical development, diagnostic development.
- Demonstrated scientific acumen and mechanistic understanding of disease biology and experience in oncology and immuno-oncology drug development (small molecule and biologics)
- Experience with developing and implementing translational biomarker strategies to align with clinical development objectives.
- Experience in the design and generation of clinic-ready biomarker assays in oncology.
- Excellent verbal and written communication skills across all levels both within an organization and with external collaborators/companies with the ability to recognize, articulate, and accept calculated risks to make informed decisions.
- Demonstrated ability to lead others through change by navigating ambiguity, creating the context, and engaging individuals.
- Comfortable working in a fast-paced environment where speed is paramount.
- Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets.
- Demonstrated experience in the appropriate application of various scientific technologies into translational research strategies and working knowledge of all functional areas of drug development, including, biology, toxicology, clinical development, diagnostic development, etc.
- Demonstrated ability of working effectively to influence stakeholders in a highly dynamic matrix organization such as BMS and the ability to grow new leaders and delegate key projects appropriately.
- Working knowledge of all functional areas of drug development, including, biology, toxicology, clinical development, diagnostic development, & demonstrated scientific acumen and mechanistic understanding of disease biology.