Bristol-Myers Squibb Company

Director, Global Clinical Documentation & Submissions

Location
Princeton, NJ, US
Posted
Jun 22, 2018
Ref
R1506721
Required Education
Bachelors Degree
Position Type
Full time
About Bristol-Myers Squibb:

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.

Responsibilities:

The role of Director, Global Clinical Documentation & Submissions will report to the Head of Global Clinical Compliance & Continuous Improvement (GCC&CI) within Global Clinical Operations (GCO), and will be a key member of the GCC&CI Leadership Team.

This role will support GCO through the management of three major processes in the end to end life cycle of Clinical Trials.

1. Clinical Trial Application (CTA) documentation and submission. This includes tracking of submission requirements, determination of the appropriate submission strategy with Health Authorities and Ethics Committees, generation of the appropriate documents needed for initial CTAs and subsequent submissions globally including end of trial and distribution of the Clinical Study Reports.

2. Clinical Trial Transparency across the portfolio of clinical trials. This includes providing clinical trial data to patients and the public while ensuring that the applicable legal and regulatory requirements for clinical trial disclosure are met.

3. Informed Consent Form process. An evaluation of the current state and a proposal for improvement and for global oversight will be performed, including the establishment and maintenance of a central Library, and the transition to the future state with eConsent.

This role will lead a team of individuals who have demonstrated core expertise Good Clinical Practice (GCP), ICH and Health Authority rules and regulations. As a matrix leader, the Director of Global Clinical Documentation & Submissions will collaborate with key stakeholders throughout Research and Development including Regulatory, Safety, Quality and other members of GCO to assure document standards are applied consistently across the globe. They will look for opportunities to streamline processes, leverage technology and establish clear metrics for performance.

Externally, this will be an opportunity to help shape the regulatory landscape through engagement with PhRMA, EFPIA, TransCelerate, and other organizations.

Qualifications

  • A minimum of a Bachelor's Degree in Life Sciences or equivalent is required. At least 10 years in the pharmaceutical industry and 5 years of experience in clinical trial operations is required.
  • Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a diverse and international team
  • Customer focus and ability to navigate a matrixed organization and multiple cultural diversities
  • Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact. Thorough knowledge of drug development process and clinical operations as well as core understanding of good documentation practices.
  • Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks
  • Attention to detail with excellent planning, time management and organizational skills
  • Excellent communication and presentation skills, high level negotiation skills and the ability to resolve conflict in a constructive manner
  • The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.