Job Description
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.

Role Overview

Functional and strategic leader of the BMS team responsible for Ligand Binding Assays (LBA) used in BMS clinical development. Assays developed and managed by this team are used to support key decisions in asset development, clinical studies, and registration. The Director of Ligand Binding Assay Development manages a team of approximately six highly experienced scientists and several supporting contract lab scientists. Provides scientific input and direction in developing, validating, and implementing bioanalytical LBA assays, including a significant portfolio of externally partnered and contract research organization (CRO) development programs. With support of technical program management, responsible for executing the LBA project portfolio in alignment with Translational Medicine and Development team priorities and reporting of portfolio status and impact to leadership. Provides LBA expertise to BMS Diagnostic Sciences programs. Also responsible for management of the team’s budget, resource planning, equipment/facility, quality/compliance.

Strategic leadership attributes of the role:

Provide strategic vision and leadership for the LBA biomarker team to meet the challenges of the novel portfolio.
Develop LBA platform and capabilities strategy to support target engagement, pharmacodynamic, mechanisms of drug action, and predictive biomarkers assay development
Build cross-functional relationships and collaboration with diverse BMS stakeholders, including across functions, geographies, suppliers, external assay development partners, and collaborators.
Monitor and evaluate emerging LBA technologies for relevance to the BMS portfolio; provide direction to business development (BD) activities supporting LBA capabilities
Establish and execute on innovation programs supporting the LBA platform that align with and create future Translational Medicine capabilities
Functional leadership attributes of the role:

Accountable for project assessment, prioritization, resource allocation and execution of the LBA book of work (BoW)
Achieves objectives and manages team in a manner consistent with the Core BMS Behaviors.
Responsible for career development of the team members and education/mentoring of peers, colleagues, stakeholders, and leadership.
Works with teams and interfaces with Clinical, TM and CROs to develop biomarker support capabilities. Leads LBA Team in providing support to the biomarker programs.
Accountable for laboratory, process, assay development and data compliance, including required training in BMS including, but not limited to GCP, SOP, safety, and other guidelines.
Evaluation and development of external partnerships supporting LBA development, validation, and testing.
Includes scientific, regulatory and department perspectives in decision making. Seeks management input when issues arise where policy or regulations do not clearly define an approach or resolution.
Development and/or contribution to biomarker-related content in Health Authority submissions and external publications
Technical attributes of the role:

Knowledgeable in Ligand binding bioanalytical techniques, reagents, and methods development; LC-MS assay development experience a plus
Accountability for delivery of appropriately robust methods, data, and knowledge to meet project timelines and quality requirement
Understanding of the appropriate regulations, processes, and Verification & Validation requirements to meet CLIA, IUO, and IVD assay design requirements
Development and application of assay quality control methods, including reagent and assay control development, quality monitoring such as statistical process controls (SPC) methodologies, clinical data monitoring
Knowledge of the biomarker process as an integral part of the drug development process and the applicable regulatory requirements.
Experience Requirements

PhD with 8 to 12 years of relevant experience or equivalent of combined educational and industry experience in relevant scientific discipline such as analytical chemistry, biochemistry, etc.
Project and team leadership in a complex matrix environment, including senior leadership interactions
Leadership of technical team, including staff development, project management, resource planning, budget oversight
Experience identifying, contracting, and managing external alliances, partnerships, and service providers
Equipment, process, quality, and facilities management in a regulated environment
Comprehensive application of GCPs, 21 CFR Part 11 and ISO Guidelines as relevant to bioanalytical assay development and testing in a regulated environment.
Contribution and/or leadership of bioanalytical assay SME content in Health Authority submissions; experience with IVD development a plus
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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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