Associate Director, Clinical Safety Strategy and Solutions
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.
Functional Area Description
The WWPS group is responsible for ensuring the safety of our medicines and pharmacovigilance and pharmaco-epidemiology deliverables including: single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Lead and manage the Clinical Safety Program for various assigned assets in collaboration with colleagues within Global Drug Development (GDD) and Research and Early Development (R&ED) and entire cross-functional matrix, to ensure that CSP strategy and key research collaborations are executed in alignment with safety strategy defined for given assets.
Execute operational process components of CSP for assigned assets, including progressive integration of additional compound teams in alignment with goals of signal detection and assessment.
Serve as subject matter expert and key conduit of CSP by functionally aligning with leaders and roles within departments internal and external to WWPS, including Clinical Development (Early and Late), Medical Safety Assessment (MSA), Global Regulatory Strategy (GRS), Global Development Operations (GDO), Global Biometrics and Data Sciences (GBDS) and strategic/development/alliance partners.
Provide scientific and operational support of research collaborations with key academic institutions to further BMS’ position as industry leader in addressing critically important clinical research questions in the prediction, diagnosis and treatment of adverse events.
TA Leadership of CSP Vision and Commitments:
Lead and drive the execution and integration of CSP into various compound teams in alignment with CS3 TA Lead by establishing high performing project teams. Collaborate with other CS3 Leads, CS3 TA Leads and CS3 Head, physicians and members of Early and Full Development Teams (EDT/FDT), Safety Management Teams (SMT), and clinical project teams in the development of strategic plans and implementation of CSP process.
Identify, solve and define essential process components and operational aspects of CSP to align with data capture principles and quality expectations across Clinical, Compliance, Regulatory, Patient Safety and Operations.
CSP Operational Execution and Deliverables:
Fulfill activities for foundation setting for assigned assets including Scope and Strategy determination, medical concept translation to CRF and database development, regulatory and compliance documentation and adverse event identification report design.
Develop essential ongoing working relationships with key functions including WWPS MSAPs, MRSPs, Clin Trial Leads, Clinical Scientists, Operations Leads, Global Trial Managers and Clinical Data Managers.
Ensure proper event identification, tracking, site communication and retrieval of CSP data from sites for assigned assets.
Lead and support all data and medical review activities to ensure that CSP data is complete and accurate for assigned assets. Ensure timely completion of all CSP deliverables, including database locks for assigned assets.
Utilize exploratory tools and platforms (Spotfire, Proteus, Jreview, Tableau) to analyze CSP data to elucidate safety issues with MSA/SMT and support signal detection activities. Ensure application of analytic solutions to interrogate clinical safety data sets and extract medical messages for assigned assets.
Ensure CSP regulatory commitments are met and adequately reflect emerging postmarketing safety profile.
Deliver CSP data to key stakeholders and partners for utilization in CSRs, Safety updates, Narratives to address questions from Health Authorities and in preparation of advisory committees and DMC meetings.
Support CSP adjudication as required for asset teams to meet their safety goals.
Participate and collaborate in strategic collaborative interactions with external partners for CSP activities (ie other industry biopharma partners, CROs, academic centers, etc.). Ensure all relationships are appropriately trained to conduct the research as agreed upon.
Technological Solutions and Analyses:
Utilize existing and new technologic advancements to support CSP/WWPS activities and lead/participate in such projects in conjunction with key business and executive leaders.
Cross-Functional Partnerships, Research Collaborations:
Partner with colleagues within WWPS including Medical Safety Assessment Physicians (MSAPs), Epidemiologists, and Medical Review Safety Physicians (MRSPs) identify innovative practices for risk assessment and minimization for BMS products.
Departmental Initiatives and Team Career Growth/Leadership:
Drive change in the organization and adoption of new processes and participate and/or lead in the execution of new ideas and initiatives to support advancements within WWPS.
Participate as a key member of matrix design and demonstrate teamwork amongst colleagues and contractors.
Degree / Experience Requirements
BA /BS / Assoc. Degree required. Experience in TAs of immunology, oncology, cardiovascular, metabolics desirable.
2-4 years in PV, Clin Dev/Ops or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is required.
Key Competency Requirements
Clinical knowledge base combined with excellent written an verbal communication and organizational skills. Ability to manage multiple projects in parallel.
Working knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
Understanding of drug development process, with experience-driven knowledge of design and execution of randomized clinical trials, regulatory requirements, and conditions for commercial success.
Demonstration of scientific analytical reasoning skills and strong working experience of essential technologies and clinical/safety databases.
Behavioral competencies necessary for success in a complex matrix environment and project leadership.
Working knowledge of regulatory requirements for safety assessment and action.
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.
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