Bristol-Myers Squibb Company

Director, Centralized Monitoring

Location
Princeton, NJ, US
Posted
Jun 03, 2018
Ref
R1506203
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

The Director, Centralized Monitoring is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Head of Global Data Management and Centralized Monitoring within Global Clinical Operations (GCO).

Specifically, the Director, Centralized Monitoring is accountable for:

Providing operational leadership of the centralized monitoring function enabling effective risk-based monitoring of quality and risk in critical processes and data collection that leads to the delivery of complete, high quality and reliable clinical trial information for internal decision making, regulatory approval and market acceptance.

Managing BMS' library of risk category definitions, key risk indicators, and quality tolerance limits. Ensuring consistent implementation at a study level, including the definition and enablement of any clinical trial-specific requirements.

Providing key stakeholder input to identification of critical processes and data during risk assessment performed during clinical trial protocol development.

Coordinating with global clinical compliance and continuous improvement, regional clinical operations, clinical data management, statistics, and clinical data reporting and analytics to establish tools and mechanisms (including statistical concepts) that enable proactive monitoring of risks to critical processes and data collection.

Providing regular documented communication to stakeholders during the course of clinical trial execution that demonstrates regular risk review, including collaborating to define and document risk mitigation activities as needed.

Describing the quality management approach implemented for a clinical trial and summarizing deviations from quality tolerance limits in the clinical study report.

Understanding industry evolution to provide insight in the development and application of smart systems and optimal approaches to clinical trial risk management that assure patient protection and reliability of clinical trial results.

Establishing and implementing the quality management strategies supporting regulatory filings, publications and other high-profile business activities.

Focusing on continuous improvement, defining and implementing the changes required to create an industry-leading centralized monitoring function.

Leading a multi-national team of clinical trial and data management professionals that contribute significantly to BMS portfolio of clinical trials. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowers and holds staff to high quality performance and delivery of the business.

Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to centralized monitoring.

Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.

Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

Experience and expertise required:

Bachelor's degree required with an advanced degree preferred. At least 8 years of relevant industry experience, with substantial experience of managing staff in a global setting.

Significant global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Strong experience interfacing with investigational site staff and well versed in industry trends and emerging industry dynamics concerning clinical trial processes and data collection.

Previous leadership within a centralized monitoring, risk based monitoring, statistical, and/or data management role developing systems to support enhanced data review methodologies.

A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)

Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.

Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a large, geographically diverse team.