Consultant Clinical Scientist Oncology (6-months full time role)

Posted 11 months ago

Key responsibilities:

  • Drive development of protocols/protocol amendments for clinical studies
  • Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
  • Work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical trial
  • Contribute to development of end-to-end clinical development strategy
  • Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
  • Monitor, review and interpret safety and efficacy data of ongoing clinical trials
  • Act as (clinical science expert) liaison to cross-functional project core team, clinical study teams, CRO’s, study sites and others
  • Establish relationships with investigators, KOLs, partners and appropriate consultants
  • Provide clinical scientific input to business development (e.g. due diligence) and marketing activities
  • Perform literature research
  • Develop and deliver presentations to internal and external stakeholders. Provide input in scientific communication plan and scientific publications

Your profile:

  • Master’s in Life Sciences, Pharmacist or PhD in Life Sciences (preferred)
  • At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols
  • Experience in conducting Clinical Studies in Oncology
  • Experience in Prostate Cancer
  • First experience working on studies in Anti-infectives in an asset
  • Broad experience in the principles and techniques of data review, analysis, signal detection, interpretation and clinical relevance
  • Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations
  • 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.
  • Driven and proven abilities to perform responsibilities independently and with limited guidance
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget delivery. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
  • Strong interpersonal, verbal/written communication, negotiation and influencing skills in English
  • 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

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