Bristol-Myers Squibb Company

Lead, CT Transparency and Disclosure

Location
Princeton, NJ
Posted
Nov 27, 2018
Ref
R1511883
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 Lead, CT Transparency and Disclosure will lead the strategic development of activities and resources in support of global Transparency requirements: Clinical Trial Registration, Results Disclosure, Data Sharing and development of Plain Language Summaries (PLS).

Key Responsibilities and Major Duties:

  • Oversees clinical trial registration, scientific and plain language results disclosure, and data sharing activities
  • Provides leadership, infrastructure, and subject matter expertise for the clinical trial transparency and disclosure organization
  • Assists and trains internal and CRO teams on disclosure and transparency processes
  • Collaborates across multiple functions (Clinical Operations Teams, Biostatisticians, Medical Writers, Medical Monitors, Protocol Managers, Legal, Publications team, Regulatory Affairs, Investor Relations, Business Insights and Analytics and IT) to ensure adherence to regulatory requirements and identify efficiencies
  • Maintains continuous knowledge of the regulatory requirements and industry trends related to disclosure and transparency
  • Communicates and plans internal and external communications related to clinical trial disclosure and evolving regulations/policies
  • Leads change management and collaborates with cross-functional stakeholders to support the evolving disclosure landscape
  • Builds and owns processes and SOPs to ensures consistency, accuracy, and timeliness of data for public disclosure
  • Leads continuous improvement initiatives related to registry data and data sharing
  • Leads and participates in cross-industry initiatives related to clinical trial disclosure and data transparency
  • Prioritizes organizational activities and provides strategic input; assesses risks and reward to direct decision-making for the organization
  • Reports on metrics/KPI's across the organization
  • Grows and develops internal staff to strengthen the organization


List of minimum requirements
  • Degree/Certification/Licensure
  • BS, MS, or PhD in scientific or medical field


Experience - Responsibility and minimum number of years
  • Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in health sciences or related industry
  • Demonstrated understanding of US and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc)
  • Strong working knowledge of CTMS and clinical document management systems
  • Experience authoring or reviewing scientific/clinical documents
  • Familiarity and comfortability working with and discussing scientific data
  • Strong leadership and people management skills. Able to set ambitious goals for self and team.
  • Demonstrated ability to work independently and seek out support when needed
  • Exceptional written and oral communication skills. Experienced in facilitating tailored presentations to internal and external stakeholder groups.
  • Adaptable and able to modify personal and organizational work style to meet the needs of the business.
  • Ability to prioritize work and assess risk to meet the needs of the organization
  • Strong organizational and technical ability. Demonstrated excel. PowerPoint, and SharePoint skills.
  • Highly motivated and passionate about continuous learning and organizational development