Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

The Director, Clinical Data Strategy & Solutions is a leadership role accountable for defining and providing governance to the clinical data strategy in support of operational activities alongside the Clinical Systems & Advanced Analytics Director and the Study Delivery Report leadership team.

Position Responsibilities

• Lead and provide strategy and solutions for clinical and operational data to support business processes
• Collaboration with IT, business owners, reporting technology providers, and internal stakeholders to ensure systems are meeting BMS expectations and enhancement requirements are being appropriately considered in the provider’s roadmap.
• Responsible for the Clincal Data Review processes, including development and execution of automation and innovation strategies 
• Lead company acquisitions (e.g. process conversion, system,  data/system flow, etc.) to enable transition of operational activities that impact CDR&A and cross functional stakeholders
• Lead and support governance with Information Technology (IT) and other key stakeholders to ensure clinical data warehouse ecosystem enables an efficient, effective, and compliant delivery of clinical data
• Provide operational leadership and guidance in development of Quality Documents (i.e. SOP/WIs) to Subject Matter Experts in the development and maintenance of global processes, procedures, and training materials by establishing a strategic vision to ensure efficient, effective, compliant working practices.  Establish appropriate structures and processes to execute the strategy.
• Serve as the central point of contact for CDR&A regarding GxP audits and inspections, coordinating with CDR&A Leaders and SMEs on the preparation and subsequent follow-up activities.
• Provide guidance and direction to SMEs to ensure the procedure development process, content and format comply with Global GxP requirements, BMS Global Quality Standards, and BMS’ QMS principles of integrated, patient-centric, and risk-based decision-making.
• Collaborate with other Process Owners and SMEs to drive optimal execution of processes across BMS and external partners.
• Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms
• Establish SLAs and KPIs to be able to measure performance for continuous improvement opportunities
• Lead initiatives to scope, plan, and implement process/tool improvements and use of appropriate change management and communication principles.
• Lead effort in the development of inspection readiness templates and flows (e.g. clinical ecosystem flow diagram, system list template, (PMDA), process flow, etc.) . 
• Provide guidance to ensure effective corrective and preventative action plans are defined for any CDR&A related audit and inspection findings and actions plans are tracked to completion.
• Collaborate with R&D Learning to define and maintain role-based procedure training curricula.
• Ensure adaptive management of a global team through the effective deployment of resources and streamlined processes.
• Develop and promote a work place culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.
• Lead the resolution of complex issues related to the function and those that cross functions.  Direct team members as needed to drive to resolution and keep leadership informed of progress/results.
• Develop strong and productive working relationships with key stakeholders throughout BMS, demonstrate the ability to think strategically across R&D, and effectively influence peers and senior management.
• Represent the company with key external organizations as part of any committee or industry group relating to GxP/QMS, data quality & integrity activities.
• Ensure effective quality oversight and management of external partners (e.g., Function Service Providers, CROs, technology providers, etc.)

Degree Requirements

• Bachelors degree required with an advanced degree preferred

Experience Requirements

• At least 10 years of relevant industry experience in concentrated disciplines of R&D, Operations, Validation, and/or Quality preferred.

Key Competency Requirements

• Expert understanding of the drug development process and clinical trial execution.
• Expert knowledge of industry trends and emerging technologies supporting clinical trial data acquisition and management.
• Expert knowledge of GCP/ICH guidelines.
• Expert Knowledge of Clinical Ecosystem data and and process framework
• Expert knowledge of Clinical data management systems (e.g. EDC, eCOA, IRT, etc.)
• Proven track record of resolving complex issues and driving significant initiatives to completion.
• Ability to lead and make decisions with an enterprise mindset, considering what is best for the company and for patients.
• Proven track record in functioning within a global matrix organization exerting positive, effective influence to achieve quality outputs.
• Demonstrated change agility in anticipating and leading others through change and ambiguity.
• Demonstrated partnership across various collaborative and industry forums.
• Demonstrated people management experience.

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.