Director Clinical Scientist Consultant

Position Summary:
Seeking an experienced, motivated, outgoing Director Clinical Scientist . Reporting to the Head of Early Phase Oncology Clinical Development, the Director/Senior Director will work closely with the clinical leader providing medico-scientific expertise to one or more clinical projects. What you'll do:

• • With the clinical leader, writing clinical development concepts and plans for molecules at all stages of development
  • Writing initial and or later drafts of protocol synopses, protocols and protocol amendments
  • Writing/reviewing informed consent forms and reviewing/adjudicating site-specific ICF requests
  • Partnering with Clinical Operations on site selection, start-up and communication
  • Writing or updating clinical sections of investigator brochures and leading the team that writes the initial brochure and subsequent annual updates
  • Writing/reviewing clinical/safety sections of NDAs/MAAs
  • Representing the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leader
  • Serving as a member of the clinical sub team
  • Reviewing and interpreting data listings including safety data and serious adverse events
  • Assisting with or serving as primary author of clinical study reports and associated publications
  • Creating clinical study- or program-related slide decks for internal and external use
  • Training of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriate
  • Organizing and participating in opinion leader advisory boards
  • Contributing to or performing therapeutic area/indication research and competitor analysis
  • Building and maintaining opinion leader/investigator networks
  • Support Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal audits
  • Support HA updates and submissions
  • Additional study level activities include presentation of study results to internal and external committees or advisory boards, presentation of data at international scientific meetings and publication of study results in peer-reviewed journals. In addition to study level activities, the Director/Senior Director will participate in program level activities including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety updates and clinical sections of product labels.

• • Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required. Training and experience in immuno-oncology desired
  • Postgraduate qualification in clinical oncology (e.g., Master’s degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhD
  • At least 2 years of industry experience in oncology
  • Previous participation in a clinical development program is essential, preferably involvement in early phase FIH clinical trials (i.e., from IND filing to to study report)
  • Skilled in protocol design, interpretation, and medical monitoring
  • Experience in assessment of adverse events and safety of patients participating in therapeutic clinical trials is preferred
  • Knowledge of Good Clinical Practice
  • Excellent written and oral communication
  • Capacity to adapt to a fast-paced and changing environment
  • Fluency in English is required.