Associate Director - Immunology Clinical Biomarkers, Translational Medicine

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Translational Medicine at BMS

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our people are focused on helping millions of patients around the world in disease areas such as oncology, hematology, immunology, cardiovascular and neuroscience. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient at the right time to achieve the best outcome.

Summary/Scope

Reporting to the Director, the Associate Director will be part of the Immunology, Cardiovascular, and Fibrosis Translational Development Disease Team based in Princeton, NJ. The individual will support operational aspects of TM and clinical biomarker activities to support late stage drug development programs in lupus, including SLE, lupus nephritis, cutaneous lupus, and other disease areas within immunology. This individual will also have the opportunity to guide research programs within the translational laboratories, and will act as the translational medicine representative on development teams and assume primary responsibilities, such as interacting with CROs and KOLs to support contracting, sample analysis and data delivery of biomarkers in clinical studies. The successful candidate will have prior experience interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of medicines to patients in need.

Responsibilities will include, but are not limited to, the following:

• Responsible for managing the timelines and activities associated with biomarker data delivery such as biomarker and assay selection, contracting, sample analysis, and report finalizations, and involvement in trial-specific biomarker plans (e.g. biomarker components, protocol development)
• Implements translational activities through direct interaction with clinical research physicians, statisticians, clinical operations, computational biologists, contract research organizations, academic experts, and internal translational scientists

• Aid in biomarker data delivery for clinical studies through working with relevant functions and CROs; responsible for aiding in creation of SOWs and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement.
• Provides guidance on clinical biomarker data analysis to Global Biometrics, and Informatics and Predictive Sciences
• Evaluates CROs for data analysis and delivery capabilities, in conjunction with Translational Sciences and Precision Medicine
• Prepares and delivers presentations within the department and externally
• Supports regulatory submissions and regulatory interactions as needed

Skills/Knowledge Required

• Understanding of drug development, especially late stage development
• Experience in activities required for and related to clinical trial initiation, maintenance and completion
• Experience in global regulatory filings
• Experience in interacting with CROs and KOLs to manage projects and timelines
• Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
• Accountable for timelines and deliverables
• Prioritizes risks and implements contingency plans
• Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally
• Recognizes cross-functional issues and communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks.
• Ability to prioritize and manage time efficiently
• Strong verbal and written communication skills
• Accurate and detailed record keeping
• Excellent organizational skills

Education:

Ph.D., and 5+ years of biotechnology or pharmaceutical industry experience. Candidate must be a rigorous, detail-oriented scientist, with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment.

Functional/Scientific/Technical Skills:

• Contributing to research program and business.

• Subject matter leader.

• Broad knowledge of multiple functional technologies.

• In-depth understanding of function as it relates to project.

• Functional area expert with skills, theoretical knowledge and experience to apply scientific direction and approach to projects and problems.

Tasks and Responsibilities:

• Completes technical assignments by designing, executing and interpreting complex experiments.

• Recommends department level strategic decisions.

• May lead scientifically on cross functional assignments.

• Manages and/or coordinates workflow on projects.

• Apply diverse scientific knowledge to assignments.

• Development of research tools.

• Interpret results.

Discretion/Latitude:

• Helps design operational strategies consistent with department goals.

• Provides input and makes recommendations to research strategies.

Creativity and Problem Solving:

• Identify & solve multi-faceted challenges.

• Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.

• Identify risks.

• Contributes ideas and develops/presents a scientific case (or position) inside and outside department/group.

Teamwork and Influence:

• Communicates with cross functional team.

• Directly impacts the achievement of workgroup/team goals.

• Represents workgroup/team or department on multi-disciplinary or cross functional teams.

• Work across departments.

Organizational Impact:

• Direct impact on departmental performance.

• Impact is achieved by driving team efforts.

• Able to conceptualize broad impact of research programs and personal activities in terms of site.

Behavioral Competencies:

• Champions change

• Leads courageously

• Networking

• Provides directions

• Structuring and staffing
• Thinks strategically

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 the resources to pursue their goals, both at work and in their personal lives.