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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 build 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 (PSM) and an enrollment timeline, that factors in estimated site activation roll-out, for a clinical study.

• Creates and maintain patient enrollment forecast. 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.

• Responsible for scenario modeling (re-projection and re-planning) and accrual forecasting to determine the likelihood of the scenarios, and inform clinical/study teams.

• Throughout the enrollment period, drives the production of analytics that tracks patient accrual vs. plan, responsible for ongoing updates to the clinical/study teams, including relevant changes in actuals that may impact study timelines or performance.

• Core member of Study Team and Country & Site Selection Team (CSST)

• 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.

Degree Requirements: BS/BA degree; preferably in a scientific discipline or allied health field (e.g. information science, epidemiology, life sciences). Advanced degree beneficial.

Experience Requirements:

• 2+ years career experience.

• Clinical or pharmaceutical/healthcare industry experience preferred

• Experience with country and site selection, trial feasibility, enrollment forecasting preferred.

• Experience participating in cross-functional teams

Key Competencies Requirements:

• Strong proficiency with excel, including generation of formulas, graphs, pivot tables, etc

• Demonstrated experience using industry competitive intelligence tools and/or ability to quickly assimilate and integrate the use of new tools/technologies

• Good understanding of analytical techniques to interpret and present data to stakeholders

• Strong oral, written and interpersonal communication skills

• Strong leadership skills; including, collaboration, self-development, self-awareness, strong ethics/integrity

• Strong problem-solving skills; including listening and decision making

#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1580903

Updated: 2024-05-15 02:20:09.176 UTC

Location: Princeton-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.