Director, Translational Biomarker Strategy Lead
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Tumor Microenvironment Thematic Research Center (TME TRC) is focused on developing therapeutic targets at the intersection of tumor, stromal and immune biology within the TME with the goal of enhancing responsiveness to checkpoint blockade and targeted therapies. Comprising of scientists across multiple disciplines we are responsible for the biology and translational science necessary to support drug development from target identification through to first in human studies.
We are seeking a highly motivated and experienced individual with deep translational expertise to join the Translational Development team within the Tumor Microenvironment Thematic Research Center (TME TRC) at Bristol Myers Squibb in Redwood City, CA.
The Director, Translational Biomarker Strategy Lead will lead a team of 3 PhD level biomarker leads dedicated to delivering translational and biomarker strategies for the TME TRC portfolio of oncology/ImmunoOncology programs. The Lead will bring deep scientific experience with emphasis on oncology/ImmunoOncology 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 clinic-ready pharmacodynamic, mechanism of action, target engagement and patient selection assays and strategies, in alignment with clinical development objectives, for TME TRC programs.
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.
Establish and execute well-crafted translational and biomarker strategy for all development candidates within the TME TRC, focused on target engagement, mechanism of action, pharmacodynamic biomarker and patient selection assays.
Providing guidance, oversight, scientific input and biomarker expertise for execution, & review of all biomarker aspects of early development plans and academic collaborations including resultant publications and posters, as well as for relevant documents (such clinical protocols, sample collection tables, sample collection instructions and logistics, investigator brochures, regulatory documents, etc.)
Integrates translational research and clinical development, develops a biomarker strategy in alignment with clinical development objectives and leads efforts for data generation, assay development and clinical biomarker sample analysis data 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.
Ensure progress of translational plans into implementation and execution via internal technical assay execution and/or execution with external contract research organizations (CROs) and specialty testing labs.
Support due diligence and asset integration activities as needed.
Proactively provide insight into novel ways to incorporate biomarkers into clinical designs to enable early understanding of emerging drug profiles.
Communicates key biomarker program information, risks, risk mitigations and milestones, and manage information flow across key stakeholders including therapeutic area leadership, functional leads and team members, independently 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.
Participate in strategic overview of presentations, publications and internal/ external communications along with accountable program leadership.
MD, PhD or MD/PhD or equivalent advanced biology degree with 12+ years of industry experience in oncology drug discovery and development process, preferred within translational biomarker roles.
Proven track-record in successfully managing and leading a team of scientists.
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 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
Experience from FIH through at least phase 2 trials, including directly contributing to translational biomarker and sample collection strategies
Willingness and ability to effectively cooperate and partner with external providers and others within BMS.
Demonstrated experience in the appropriate application of various scientific technologies into translational research strategies (e.g. flow cytometry, immunoassays, genomics, immunohistochemistry and multiplex approaches, etc.) 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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.