Translational Biomarker Strategy & Development Associate Director
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, creative individual with deep translational expertise to join the Translational Development team at Bristol Myers Squibb in Redwood City, CA.
The Translational Biomarker Associate Director will be responsible for delivering translational plans and biomarker strategies for multiple oncology programs at asset level. He/she 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. He/she will integrate translational research and clinical development, be responsible for the design, delivery, and execution of biomarker & translational strategies from program inception through First in Human, including initial patient selection, pharmacodynamic endpoints, pharmacodynamic (proximal and distal), and stratification strategies in alignment with clinical development objectives, clinic-ready target engagement, as well as pharmacodynamics biomarker assays for TME TRC programs.
At the asset level, design, develop, establish, and execute well-crafted translational plans and biomarker strategy strategies for multiple development candidates within the TME TRC, focused on clinic-ready patient selection, mechanism of action, target engagement and pharmacodynamic biomarker assays and clinic-ready patient selection assays.
Accountable for analysis of the data, generating study reports, developing SOPs and all pertinent documentation and responses for assigned programs.
Effectively partner within a highly matrixed organization, within the Translational development groups & with external partners to deliver high-quality biomarker data and drive the advancement of therapeutic candidates.
Accountable for providing 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, INDs, regulatory documents, etc.).
Progress translational plans into implementation and execution via internal technical assay execution and/or execution with external contract research organizations (CROs)
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.
Provide oversight to progress validated biomarkers into development of pharmacodiagnostic tools.
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 10+ years of relevant industry experience in the drug development process, preferred within translational biomarker roles.
Hands-on experience in the design, execution and generation of clinic-ready translational biomarker assays in oncology.
Deep understanding of the role of translational research/medicine and clinical biomarkers in drug development.
Demonstrated scientific acumen and mechanistic understanding of disease biology and experience in oncology and immuno-oncology drug development (small molecule and biologics).
Experience from FIH through at least phase 2 trials, including directly contributing to clinical translational and biomarker components of study protocols, investigator brochures, regulatory documents and INDs.
Excellent communication skills across all levels within an organization and external.
Demonstrated ability to lead and influence others in a highly matrixed work environment.
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.
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.
Working knowledge of all functional areas of drug development, including, biology, toxicology, clinical development, diagnostic development, etc.
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.