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Associate Director, Global Medical Affairs

New Jersey All, NJ

Posted: 08/21/2018 Job Type: Clinical Job Number: JN -082018-22376
  • Represent Global Medical Affairs in cross functional teams/meetings, e.g. Project Teams, Clinical Sub-teams, and Medical sub teams if required
  • Collaborate with all Regional Disease representatives and functional teams in Medical Affairs on Disease strategy and tactics
  • Support Medical affairs cross-functional sub team meetings
  • Support in the execution of Global advisory boards and steering committee meetings, but also be involved in assisting the regions on critical globally impactful advisory boards
  • Perform, as needed, research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning
  • Conduct research and provide directed analytics and valuable backgrounders, as well as provide recommendations to guide Medical Leadership Investigator Initiated Trials (IITs) decisions
  • Support company at professional meetings, congresses, and local symposia
  • Track and coordinate with Regional & Affiliate Medical Affairs tactics in Disease Plans
  • Partner with Scientific Communications on developing Disease publication strategy, gap analysis, key messages in coordination with the Regions
  • Tracking and/or requesting of Compassionate Use or other early (expanded) access programs
  • Disease strategy/plans
  • Abstracts, posters, slides, manuscripts in disease area
  • Educational materials in disease area including slides, webcasts, etc.
  • Cooperative group proposals, study concepts, and IIT proposals and protocols in disease area
  • Key Opinion Leader (KOL) Steering committee meeting objectives, materials
  • Clinical Development Plans (CDPs), Commercial Brand Plans, Integrated Disease Plans
  • Open Research Questions process (ORQs) in disease area
  • Scientific educational grant requests
  • Patient advocacy grant requests in collaboration with the Advocacy team, serving as matter of expert
  • Support the planning and execution of Global Medical Affairs Sponsored Trials, within appropriate standards for compliance, quality, timeliness, and budget
  • Seek input from experts in the field on protocol design
  • Complete full protocol in collaboration with Medical writing
  • Collaborate with Project Team and Clinical Operations on study start-up, to include site selection, Informed Consent development, Investigator meeting(s)
  • Medical Monitoring plan, and review data on an ongoing basis
  • Develop activities to enhance patient recruitment
  • Review of ongoing tables, figures and listings along with patient profiles to determine safety and efficacy endpoints for company sponsored and/or registry studies
  • In collaboration with statistics review data, prepare abstracts and publications, and prepare Clinical Study Reports
  • Assist with scientific searches, data summaries, preparation for site visits/corporate visits
  • Track priority Medical Affairs tactics and performance to goals/budget
The ideal candidate will have the following mix of professional and personal characteristics:
  • Advanced degree (MS, Pharm D, or PhD or others) in molecular biology, genomics, cancer biology or other relevant life sciences area
  • Oncology/Hematology Medical Affairs experience within a sponsor company
  • Demonstrated understanding on Myeloid Diseases
  • Excellent analytical skills and some experience in translating medical/clinical information into medical affairs strategies
  • Experience with mining of information from tumor databases and other bioinformatics skills will be a strong plus
  • Proficiency in scientific and clinical data review and interpretation
  • Previous experience with cross-functional teams in matrix environment
  • Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions
  • Demonstrated customer focus orientation & credibility with customers
  • Knowledge/application of data sources, reports and tools for the creation of solid plans
  • Hard working with a can-do attitude
  • Possess experience creating and managing budgets
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