Senior Director, Global Feasibility
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 Senior Director, Global Feasibility is an experienced clinical research professional responsible for managing a team to improve BMS’s ability in developing predictive and prescriptive models to enable sound protocol design and effective planning and execution of global clinical studies. This support encompasses phase 1 (ED) to phase III studies for internally and externally conducted clinical studies of the BMS portfolio as well as for support of business development search & evaluations activities.
In collaboration with the head of Clinical Trial Analytics, the Senior Director, Global Feasibility will create and communicate a compelling vision for the group that promotes continued growth of the capability, employee engagement and aligns with the future direction of BIA R&D and company goals.
Identifies approaches to integrate real world evidence and other sources of data to improve the creation of predictive analytics to support superior protocol design, trial execution and understanding of standard practice of medicine.
Leads efforts in formulating and articulating operational feasibility and country/site selection recommendations that takes into account therapeutic area needs, implications/trade offs and functional resource allocation.
Creates and institutes a systematic approach/methodology for core deliverables, to ensure consistency of scope and quality to stakeholders, across hematology and cell therapy clinical trials.
Creates and implements tools and procedures to assess timeframes and risks for proposed clinical trial designs, whether trials are progressing against plan, and the performance of countries/sites.
Proposes optimization of clinical trial placement across hematology and cell therapy clinical trials based on patient target, BoW and portfolio requirements.
Proactively recognizes and mitigates (as appropriate) industry trends, best practices and/or potential risks that may impact the development strategy of an asset, disease or clinical study.
Continuously assesses and interprets business needs of core stakeholders and translates them into new/enhanced processes and/or improved operational efficiencies.
Partners with BIA colleagues to incorporate customer relationship management, influence mapping and other tools/sources of information into study feasibility assessments and country/site identification.
Engages and builds effective relationships with senior leaders across Global Development Operations (GDO), Global Drug Development (GDD) and other key internal/external functions and stakeholders to drive innovation across the business.
Leads a team of global feasibility managers (8-10 people) responsible for the curation and analysis of clinical trial intelligence data and its application to study feasibility, country/site selection and data-driven patient recruitment and enrollment forecasts for Phase I to IV clinical trial(s).
Responsible for leading direct reports through employee development process (i.e. including objective setting, providing constructive feedback/coaching) and embedding a high performance culture.
Accountable for quality and accuracy of deliverables produced by the CTA group.
Provide oversight and direction on all analytic aspects of global feasibility, patient enrollment planning, and forecasting inward to the group. Represent CTA at a variety of internal forums to increase stakeholder understanding of core deliverables.
Responsible for driving continuous improvement and innovation, identifying areas for improvement and act as a sponsor or contributor to work streams and other initiatives.
Masters degree; preferably in a scientific discipline or allied health field (e.g. public health, information science, epidemiology, or other life sciences).
8+ years career experience; including 5 years experience in clinical research/operations or analytics roles preferred.
Experience with portfolio planning, clinical trial design, study feasibility, country and site selection, performance tracking and vendor management.
Strong understanding of the global drug development process and interdependences between cross-functional deliverables for Hematology & Cell Therapy (Immuno-Oncology) clinical trials
Excellent analytic skills and detailed oriented
Strong technical and leadership skills with people management and mentoring experience
Ability to provide strategic direction and oversight to direct reports as well as represent the organization at development/operational committee meetings and on cross-functional internal/external initiatives
Strong understanding, and preferably proven mastery, of Simulation/ Modeling/ Algorithm/ Forecasting capabilities to enable the creation and management of trial scenario planning, data analytics and correlation analyses using Statistical Methods
Demonstrated advanced project management skills in clinical development setting
Demonstrated experience managing and collaborating in a team/matrix work environment
Ability to direct activities and influence outcomes
Good verbal, written and interpersonal skills with effective communication and presentation skills
Strong leadership skills; including communication, collaboration, commitment and positive conduct
Strong problem-solving skills; including active listening, decision making, critical thinking
Computer and systems literate; familiarity with Microsoft Office programs, including Microsoft Project, WORD, Excel, PowerPoint, SharePoint, Tableau etc.)
Familiarity with process improvement methodologies (e.g. Six Sigma, Lean) 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.
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