Manager, Clinical Trial Information Disclosure in Basking Ridge, NJ at DSI

Date Posted: 7/15/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:

The Manager, Clinical Trial Information Disclosure leads company operational activities to comply with US, EU, Japan and other regional disclosure regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company’s compliance with current disclosure requirements and participates in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language summary, redaction and data sharing requirements.

Responsibilities:

Coordinating company initiatives, strategies and operational activities to comply with the US, EU, Japan and other regional trial disclosure regulations and the IFPMA and EFPIA-PhRMA principles, including implementation of EMA Policy 0070 (and other external policies) and its subsequent compliance.

Subject matter expert on global clinical trial registration, summary result posting, plain language summary, redaction/anonymization and data sharing requirements.
  • Monitors and assesses these requirements, creates compliant processes and provides advice to project and functional teams, as needed. Proactively identifies and manages risks.
  • Builds close working relationships with key company stakeholders across functions, as well as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade association group members.
  • Training and raises awareness of the topic of clinical trial information disclosure within the company globally. Designs and implements programs to deliver sustainable learning.
  • Provides oversight for the end to end processes across the trial disclosure area.
  • Manages vendors and CROs providing trial disclosure services to Daiichi Sankyo.
  • Effectively communicates internal compliance metrics within Daiichi Sankyo.

Member of Global Clinical Trial Disclosure Function and Operations Committee.
  • Act as the lead Data Sharing Coordinator from external sources and internal SMEs.
  • Ensure prompt responses to queries for information or documents from external sources.
  • Ensure prompt and thorough review of requests for de-identified company clinical trial data.
  • Ensure company clinical trial data on the Vivli data sharing and research portal is current.
  • Lead/co-lead global process development and procedural document drafting, as appropriate.
  • If necessary, substitutes for the Director at trial disclosure related meetings.
Drafting agendas and minutes, leading actions as appropriate and ensuring deliverables are completed on time and within budget.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Experience in the pharmaceutical industry and in the area of clinical trial information disclosure highly desirable.
  • Working knowledge of key global laws, regulations and guidelines relating to clinical trial documents and data disclosure is desirable.
  • Good general knowledge of key global pharmaceutical legislation.

Bachelor’s degree (pharmacy, biology, chemistry or related field); Master’s or PhD preferred.
  • 2-5 years of experience with a Master’s of Science degree or PhD or 5-7 years of experience with a Bachelor's degree.
  • Experience working in a global, international regulatory environment and experience interacting with regulatory authorities. Experience working within a global team framework and a multi‐cultural environment.
  • Excellent interpersonal skills; ability to work across functions in a multinational organization to accomplish results; “detailed‐oriented”; well organized and self‐motivated; high ethical behavior; excellent written and oral communication skills; Excellent influencing skills
  • Excellent research skills. Understanding of drug development and regulatory processes.
  • Experienced interactions with FDA, EMA and/ or EU National Agencies and EMA as well as with industry associations is desirable.
  • Ability to provide technical input, proven ability to plan, coordinate and lead activities simultaneously on multiple projects.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.