Senior Global Feasibility Lead
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.
Job Title: Senior Global Feasibility Lead
Department Title and Description:
Clinical Trial Analytics, R&D Business Insights & Analytics (BI&A)
Grade Level Proposed: D7
Location: NJ (Summit or PPK)
# of Direct Reports: 0
Direct Manager : Executive Director, Clinical Trial Analytics
About Bristol-Myers Squibb
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.
Purpose/Objective of the job
The Senior Global Feasibility Lead is an experienced clinical research professional who has a strong proficiency in the curation and analysis of clinical trial intelligence data and its application to effectively conduct study feasibility assessments, country/site selection activities and the creation/maintenance of data-driven patient recruitment and enrollment forecasts for clinical trial(s) within a clinical research development program.
Key demonstrated competencies for the associate director level include:
- Organizational Impact: Increased sphere of influence to study team members as well as development team members and sr. leaders/functional heads.
- Discretion/Latitude: ability to set priorities, perform core deliverables and make correlated decisions fully independent.
- Critical Thinking: 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.
- increased breadth and depth of knowledge on clinical development and the interdependences between core functional deliverables.
- advanced utility of departmental procedures and system and the ability to define and/or author next generation processes.
- advanced understanding and use cases for incorporating real-work data (RWD) into predictive analytics.
- strong technical and leadership skills that lend toward mentoring new members joining the organization.
- stakeholder management
Key Responsibilities and Major Duties
- Provide input into the clinical development strategy for an indication or program
- Provides input into indication and/ or across asset planning (e.g. country/ site tiering)
- Provides requested data analytics/insights to support business development evaluations.
- Responsible for the conduct of a study feasibility assessment for phase I- IV clinical studies.
- Collection and analysis of internal and external competitive intelligence data (e.g. incidence/prevalence of a disease, drug landscape, clinical trial landscape, treatment regimen) and its influence on protocol design, patient recruitment potential and study execution.
- Leads activities pertaining to country and site identification, feasibility and selection within a clinical study.
- Collection and analysis of internal and external data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population) and define an optimal geographic country footprint and proposed sites for participation in a clinical study.
- Collection and analysis of historical data related to prior site performance (e.g. data quality, start-up cycle time, patient enrollment predictability) in a clinical study.
- Design and execute a country and site feasibility assessment/ questionnaire to evaluate prospective sites on their operational and medical capability to conduct the clinical study within scope, cost and timelines.
- In collaboration with Global Development Operations (GDO), define final allocation of selected country and sites.
- Responsible for creation and maintenance of a patient enrollment forecast, at study and country levels.
- Building on prior research and analytics, defines patient enrollment scenario model(s) that can flex based on study objectives (i.e. speed, cost, market exposure).
- Curates and analyzes relevant data to define a projected patient rate of recruitment (RoR) and an enrollment timeline, that factors in estimated site activation roll-out, for a clinical study.
- Maintain the patient enrollment forecast from a strategic perspective. In collaboration with BIA-R&D Forecasting Analyst, responsible for re-forecasting patient enrollment models to adjust for new influence factors (e.g. change in drug landscape, protocol amendment, increased screen failure rate). Define risk/ mitigation planning.
- Core member of Clinical Operations Team and Analytics Integration Team (AIT)
- Serves as an extended member of Development Teams (DT)
- Supports ad-hoc analyses, for more advanced data insights, to address specific business needs (e.g. understanding trends within or across protocols to identify opportunities for improvement or creating cost effective synergies)
- Provides data insights/analytics, as needed, to support governance and/or operational review meetings.
- Leads/ contributes to functional and cross-functional initiatives that center on the advancement of study planning and execution through efficiency, optimization or acceleration gains.
Customer focus, attention to detail, experience with information systems and clinical trial intelligence and supporting data, extremely proficient with MS Office (Word, Excel, ppt), ability to handle multiple projects. Strong analytical competencies. Exposure to, and understanding of clinical data sets as it relates to clinical trial planning, forecasting and execution.
Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship)
- Not applicable
Key Stakeholders/Contacts - describe this position's key internal matrix relationships and key external stakeholders/clients
- Key stakeholders/clients
- CTA-Forecasting Analyst
- GDO-Protocol Managers
- GDO-Clinical Operations Leads
- Medical-Clinical Leads
- Development Teams and Dev Team Leaders
- Key matrix relationships
- Strategic, Options and Assessment (SOA)
- BI&A Commercial Forecasting
- GCO planning and leadership
List of minimum requirements
- Degree/Certification/ Licensure
- BS/BA degree; preferably in a scientific discipline or allied health field (e.g. information science, epidemiology, life sciences). Advanced degree beneficial.
- Experience - Responsibility and minimum number of years
- 5-8 years career experience; including 3 years of experience in clinical research/operations or clinical trial information roles (within BMS or relevant external experience).
- Clinical or pharmaceutical/healthcare industry experience preferred
- Experience with country and site selection, trial feasibility, enrollment forecasting preferred.
- Experiencein leading cross-functional teams
- Competencies - knowledge, skills, abilities, other
- Strong proficiency with excel, including generation of formulas, graphs, pivot tables, and preferably macros
- Demonstrated experience using industry competitive intelligence tools and/or ability to quickly assimilate and integrate the use of new tools/technologies
- Good understanding of clinical trial processes and analytical techniques to interpret and present data to stakeholders
- Strong oral, written and interpersonal communication skills
- Demonstrated proficiency in standard Microsoft Office applications as well as interactive, collaborative workspaces (e.g. SharePoint)
- Strong leadership skills; including communication, collaboration, commitment and positive conduct
- Strong problem-solving skills; including active listening, decision making, critical thinking
- Experience directly and/or indirectly mentoring a colleague
- Software that must be used independently and without assistance (e.g., Microsoft Suite)
- Excel (advanced proficiency)
- Power Point (advanced proficiency)
- Microsoft Office
- Predictive analytic technologies/platforms and visualization tools (e.g. Tableau) highly regarded but not necessary
- BMS Behaviors Required
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.