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Executive Director, Global Drug Safety and Risk Management, Hematology/Oncology

Req #: 16001957
Location: Summit, NJ US
Job Category: Medical
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Executive
Travel: Yes, 25 % of the Time
Other Locations:US- NJ- Summit West

Key Responsibilities:

Managerial

  • Workload management and resource planning for GDSRM’s support of Hematology/Oncology global development teams and projects
  • Oversight of safety management teams ensuring thorough and consistent approach to the review of safety data emerging from clinical trials
  • Training and mentoring of physician safety leads
  • Oversee quality of all safety document deliverables
  • Oversee safety role in facilitating reviews done by internal and external DMCs

Clinical Trial Safety

  • Sets safety strategy that allows for successful IND filings and initiation of first in human studies
  • Oversight of all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports
  • Oversees development of core safety information for new compounds
  • Sets the strategy and reviews and approves key filing documents including ISS, SCS, and risk management plan
  • Provide major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Celgene’s studies

Other Key Responsibilities

  • Collaborate with other functions in and stakeholders, such as clinical, regulatory, medical and other functions to increase the overall profile of GDSRM
  • Represents GDSRM in relevant Hematology/Oncology forums, both internal and external

Required Competencies—Knowledge, Skills, and Abilities

Qualifications/Experience:

  • Minimum of MD (or international equivalent) plus accredited residency
  • Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred
  • Ten (10) years pharmaceutical/biotechnology industry experience, of which at least five (5) should be in a safety role, with experience in hematology or oncology
  • Previous line/matrix management experience
  • Experience in addressing and managing safety issues in pre-approval environment

Knowledge:

  • Clinical knowledge of therapeutic area patient populations and drug class
  • Demonstrated knowledge and understanding of drug development
  • Mastery of global regulatory requirements for pharmacovigilance and drug safety
  • Expertise in analyzing clinical trials from a safety perspective

Competencies:

  • Decision making
  • Influence and persuasion
  • Scientific leadership
  • Communication skills (written and oral presentations)
  • Ability to interpret, analyze and clearly present scientific and technical data (oral and written)
  • Leadership

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