Global Feasibility Manager

Profile

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.

Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients’ lives through science. At the core of that mission are the talented individuals who contribute their “unique” skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we’re looking for talented professionals like you to join our team. What unique gene will you bring?

The Global Feasibility Manager 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 global feasibility manager 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- 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

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 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 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 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

Software that must be used independently and without assistance (e.g., Microsoft Suite)

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com