Sr. Manager, Global Feasibility

Company: Bristol Myers Squibb
Location: Princeton
Posted on: June 24, 2022

Job Description:

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.The Senior Manager, Global Feasibility 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 skill level for a Senior Manager, Global Feasibility are as follows:

• Ability to set priorities and manage multiple projects within minimal oversight
• Aware of and contributes to mitigation planning associated with industry trends, best practices and/or potential risks that may impact the development strategy of an asset, disease or clinical study.
• Recognizes and identifies problems and recommends solutions.
• Ability to articulate data insights to study team members and influence decision making
• Ability to quickly assimilate new skills and integrate core procedures as well as to provide functional input into updating/enhancing procedures.
• Easily builds cross functional relationships 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- III 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 Study Teams 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 gainsQualifications
    • BS/BA degree, preferably in a scientific discipline or allied health field (e.g. information science, epidemiology, life sciences); Advanced degree preferred
    • 2-4 years career experience; including 2 years of experience in clinical research/operations role (or equivalent) preferred
    • Clinical or pharmaceutical/healthcare industry experience preferred
    • Experience with country and site selection, trial feasibility, enrollment forecasting preferred.
    • Experience participating in cross-functional teamsAround 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol Myers Squibb, Trenton , Sr. Manager, Global Feasibility, Executive , Princeton, New Jersey