Bristol Myers Squibb Company

Associate Director, Worldwide Patient Safety Innovation

Location
Celgene, NJ, United States
Posted
Aug 21, 2020
Ref
R1527680
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary

Reporting into the Sr. Director, Innovation, the Associate Director, Innovation is a member of the Innovation group, a sub-function within Business Capabilities and Innovation (BCI); a division of Worldwide Patient Safety (WWPS).

The Associate Director, contributes to the ongoing development, implementation and successful execution of the business process optimization and automation efforts in line with the overall Innovation Strategy for WWPS; a strategic plan to enhance data driven decision making and adoption of technologies such as cognitive computing and machine learning.

The individual applies a combination of business process, user experience and leadership experience to identify, manage proof of concept projects, use-case development, business analysis, user experience and the activities associated with the automation and AI technologies within WWPS. Utilizing their understanding of business needs and PV/RM information processes, the individual is responsible for leading projects that create and expand knowledge assets and contributes to the continuous improvement and delivery excellence of PV, RM and related data in WWPS information management.

The individual is responsible for promoting a culture of data ownership and governance, innovation, collaboration and experimentation within the WWPS as well as working with the internal BMS groups; managing cross functional communication outside of BCI, and assessing business impact to determine business process optimization opportunities to improve knowledge digitization across WWPS. In addition, the individual supports activities related to the delivery of WWPS data strategies, including input into the production of evidence-based scientific literature, white papers and position papers used to support the application and adoption of new approaches to pharmacovigilance & risk management. The individual will also support the activities around evolving information requirements throughout WWPS.

Core Responsibilities
  • Provide leadership and support to process automation and other initiatives under the responsibility of the Innovation group.
  • Support program and project team activities required to implement innovation initiatives.
  • Management and lead process improvement and innovation initiatives related to knowledge digitization and management across WWPS
  • Act upon developments in PV and RM landscape; identifying and supporting changes to processes
  • Provision of support and liaison to WWPS sub-functions in the identification of process improvement opportunities


WWPS Knowledge & Digitization Initiatives
  • Advance projects for creating and expanding WWPS data strategy and knowledge management
  • Lead and manage projects related to Ontologies, Lexicons as well as Semantics related to PV & RM
  • Represent automation and digitization innovation in the Data Governance groups and efforts
  • Lead initiatives that lead to seamless access to knowledge through use of technologies
  • Represent BCI as a product owner for projects
  • Partner with internal and external stakeholders to identify, test and deploy intelligent automation


End-to-end process design, end-user experience development
  • Manage business activities related to usability testing of new WWPS systems and processes.
  • Lead teams involved in conceptualization development of future automation tools.
  • Support of innovation processes and integrate across all relevant groups within WWPS
  • Partner with Business Capabilities & Innovation team members to lead the design of insight-driven innovative strategies
  • Define and provide metric reporting and data analysis for innovation initiatives including relevant insights to facilitate decision-making process
  • Assess and interpret the process impact of automation on processes
  • Represent WWPS as required on panels at public conferences and workshops related to automation.
  • Work with BCI work-stream team members to generate opportunities.


Training & Change Management
  • In partnership with BCI team-members and responsible individuals, develop and execute change management and change readiness assessments and strategies pertaining to data and knowledge management
  • Support Stakeholder analysis and mapping, identifying potential impacts/risks
  • Manage and support activities related to design and implementation of organization and job impact analysis
  • Support, plan and manage execution of activities related to organizational change management and end user readiness as required
  • Support, lead & manage efforts related to communication and education of the user community on system progress, objectives, and requirements; and develop means to evaluate and ensure organizational readiness for knowledge management initiatives
  • Identify and anticipate organizational challenges and/or resistance; contribute to the development of risk mitigation and change management plans
  • Contribute to efforts to build change leadership knowledge and capabilities across WWPS
  • Plan and Support activities to plan, design, and execute end-user training strategies related to knowledge management projects
  • Work with BCI group team members to ensure new tools and technologies are appropriately communicated and effectively incorporated into end user training content
  • Support evaluation of instructional approaches for system end-user training
  • Conduct and support train-the-trainer workshops as appropriate
  • Support the review of end-user training materials, job aids and other materials for consistency and relevance in relation to agreed-upon training objectives


Business Process Optimization
  • Support efforts for 'Use case' development to identify and capitalize on business process opportunities.
  • Provide on-going communication of all assigned deliverables.
  • Identify and highlight risks, issues, challenges, obstacles and successes.
  • Share automation and integration best practices across BCI to maximize effectiveness.
  • Propose future directions using innovative techniques derived from insights and understanding of process functioning
  • Identify and evaluate opportunities for Business Process Optimization


Decision Making Authority
  • Development of recommendations for technology Proof-of-Concept projects
  • Development of recommendations for technology deployments
  • Decisions related to the end-to-end process design and end-user experience
  • Training and End-User change management strategy for all aspects of automation and knowledge management initiatives
  • Decisions within Innovation group that contribute to overall improvement of data strategy and automation.
  • Decisions related to Innovation group inspection readiness and risk mitigation strategies


KNOWLEDGE, COMPETENCIES & SKILLS

Learning Skills
  • Ability to engage in continuous learning and application of learned knowledge
  • Ability to quickly learn new technologies to be able to apply it in emerging needs as needed
  • Ability to learn, adopt and apply new processes (including human factor design)


Communication Skills
  • Ability to convey ideas and facts orally using language the audience will best understand.
  • Ability to convey ideas and facts in writing using language the reader will best understand
  • Ability to grasp the meaning of information written in English, and apply it to work situations
  • Ability to understand and learn from what others say


Personal Effectiveness
  • Takes personal responsibility for the quality and timeliness of work, and achieves results with little oversight
  • Ability to adapt to changing business needs, conditions, and work responsibilities
  • Diligence in attending to details and pursues quality in accomplishing tasks
  • Ability to build and maintain customer satisfaction with the work products and services offered across safety operations
  • Demonstrates consistency honesty and professionalism in all interactions
  • Strong focus on results and desired outcomes
  • Ability to manage time, priorities, and resources to achieve goals
  • Ability to maintain composure in highly stressful or adverse situations
  • Demonstrates diplomacy and handles challenging or tense interpersonal situations


Interpersonal Skills
  • Ability to build constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect
  • Ability to promote cooperation and commitment within a team to achieve goals and deliverables.


Job Family

The Associate Director, WWPS Innovation demonstrates ability to quickly gain knowledge of the conduct of Pharmacovigilance or Risk Management globally. The individual is considered a Subject Matter Expert on process optimization & business enablement;

Operational Leadership
  • Promotes and practices effective pro-active decision-making, ensuring timely coordination and dissemination of information
  • Supports Data Governance within WWPS
  • Promotes visibility of data standards as well as metrics around Data Governance
  • Incorporates ethical standards of practice as the basis of all interactions across the WWPS and external stakeholders such as Regulatory Authorities,
  • Ability to develop and implement processes and automation to support the conduct of pharmacovigilance & risk management
  • Promotes and ensures cross-functional team collaborations and interdepartmental standards and business practices
  • Attends and supports program team, departmental and organizational meetings
  • Advocates for individual, team and organizational learning opportunities


Information Management, Analytical & Assessment Skills
  • Advanced knowledge of taxonomies, ontologies and other knowledge management constructs.
  • Understanding of data steward role and data management initiatives.
  • Knowledge and application of MedDRA
  • Understanding and application of dictionaries within multiple processes in the area of drug safety.
  • Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug)
  • Advanced knowledge to integrate inhouse and external datasets (EMR, OMOP, RWE, FAERS, Vigibase)

Knowledge of Drug Safety Sciences
  • Ability to describe lessons learned from prominent events in the history of drug safety and application to the current field
  • Incorporates drug safety regulations and guidance documents into decision making, departmental infrastructure, standard operations, and metrics tracking.
  • Provides feedback to regulators on draft regulations and draft guidance documents.
  • Provides training on drug safety regulations, terminology and guidance documents.
  • Ability to apply use of medical terminology, pharmacology, or clinical background/experience to the field of drug safety.
  • Advanced knowledge of the cycle of drug development.
  • Good knowledge of risk/benefit analysis and practical application.
  • Knowledge and application of safety standards to writing of individual case safety report (ICSR) case narratives or safety sections of clinical study reports, annual and bi-annual safety reports, investigator brochures, and integrated summaries of safety.


Quality& Compliance / Analytics & Process Improvement
  • Good understanding of the need for data accuracy, completeness, consistency and integrity.
  • Appreciation of the link between medical services, quality assurance, customer service and drug safety
  • Understanding of the application of techniques and tools for process improvement
  • Ability to lead complex, strategic projects (cross-functional, cross Business Unit/Shared Service Unit)
  • Understanding of statistical techniques for data analysis and data quality
  • Ability to draw out main messages from data, analysis and research, and identify essential supporting information.


Project Management
  • Strong organizational and planning skills required including development and execution of project plans.
  • Must have ability to work independently on multiple tasks
  • Strong problem analysis and negotiation skills


Training & Development
  • Knowledge of people, processes and adult learning principles
  • Ability to analyze training needs and develop new training programs or modify and improve existing programs

Technologies

Working knowledge of:
  • Pharmacovigilance Systems (i.e. ARISg, agXchange, ARGUS, Empirica Signals, RxLogix)
  • Microsoft Office Suite
  • SharePoint 2019 or above
  • Enterprise Document Management systems (e.g. Documentum or similar)
  • Reporting Tools


Experience in:
  • Databases (SQL, Graph, Columnar and noSQL), Data Quality Tools, Data logistics (ETL, ELT)
  • Integration frameworks (SOA, Restful Services)
  • RPA (Blue Prism)
  • Machine Learning/Deep Learning across text and images
  • UI frameworks (React, Angular, Flask, Spring etc)
  • Cloud Technologies (AWS, Google), Containers
  • Big Data Technologies (HDP, Spark, others)


Business Alignment
  • Aligns the direction, services, and performance of BCI with the rest of the organization
  • Promotes organizational mission and goals, and shows the way to achieve them.
  • Promotes Open Communication


Coaching & Mentoring
  • Enables co-workers to grow and succeed through feedback, instruction, and encouragement.
  • Helps to attract and develop talent


Fiscal Accountability
  • Follows fiscal guidelines, regulations, principles, and standards when committing fiscal resources or processing financial transactions


Strategic Vision
  • Maintains understanding of the big, long-range picture.
  • Drive Innovation and supports strategy by applying a Global Mindset
  • Demonstrates adaptability while fostering risk taking and teamwork


Direct Reports
  • Automation Specialist(s), contractors


Internal/External Partners
  • Regional & Local Drug Safety Offices including Japan
  • Regional Corporate partners & WWPS data and technology partners
  • Process Improvement resources
  • WWPS Staff


Qualifications & Experience
  • Life Sciences, Information or similar background (Bachelors, Masters and/or PhD)
  • Experience/Familiarity with modern technologies (e.g. machine learning, NLP, data driven approaches) and their applications preferred
  • 7+ years Pharmaceutical/Biotechnology
  • 4+ Knowledge of semantic technologies such as taxonomies, ontologies, lexicons
  • 3+ years Drug Safety/Pharmacovigilance experience
  • 2+ years Data Governance experience


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.