Posted 1 year ago

Key responsibilities:

  • Selects, recruits, develops, manages, motivates, coaches, and appraises the performance of direct reports to ensure high-quality results and support career progression through quality development plans
  • Manages Medical Writers and Clinical Scientists workload and ensures the proper allocation of resources to projects and studies to meet company objectives and priorities
  • Provides all necessary support to help address and resolve issues. Identifies solutions for remediation
  • Builds and establishes a strong team spirit and positive organizational culture, and creates a team founded on clinical, scientific and medical writing expertise, quality, technical ability, excellence in performance and exhibiting the values and winning behaviours
  • Acts as a Senior Clinical Scientist on programs on an ad hoc basis
  • Leads and supports certain projects and initiatives whenever applicable (for example Project Review Board, compassionate use programs) and supports the establishment of technical and professional skills for the Clinical Scientist and Medical Writer group and ensure staff training is conducted and properly documented
  • May act as a Subject Matter Expert for key operational areas influencing Clinical Scientist or Medical Writer Group area and identifies areas for process improvement
  • In collaboration with QA and Clinical Operations, manage audits and regulatory inspections related to clinical studies and create an audit readiness working environment.
  • Understands Health Authority requirements and is able to participate in Health Authority inspections as required
  • Ensure high quality clinical trial data and Clinical Study Reports /outputs throughout the project life cycle, in compliance with the processes, ICH GCP and regulatory requirements.

Your profile:

  • Master’s Degree required, advanced Clinical/Science Degree is strongly preferred (e.g. PhD, MSN, MPH, etc.)
  • Experience in Oncology and/or Infectious Diseases is a plus
  • ≥7 years of relevant experience in clinical development within the pharmaceutical industry with focus on scientific, strategic and operational experience in planning, executing and reporting clinical development plans and clinical studies
  • Proven track record of leadership and people management
  • Understanding of principles of well-designed clinical trials, excellence in protocols, IB and other clinical and regulatory documents development
  • Medical/scientific expertise
  • Has knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end results
  • In-depth knowledge of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation), clinical development process, clinical trial design, statistics, regulatory processes and relevant guidelines
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, and on-target. Flexible and open-minded, able to adjust to changing circumstances
  • Experience in due diligence activities
  • Strong interpersonal, verbal/written communication, negotiation and influencing skills.
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams. Demonstrate curiosity and challenge status-quo
  • Fluent English (oral and written)

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