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Associate Director – Clinical Scientist – Oncology

Associate Director – Clinical Scientist – Oncology

CompanyEikon Therapeutics
LocationSan Bruno, CA, USA, New York, NY, USA, Hayward, CA, USA
Salary$189000 – $206150
TypeFull-Time
DegreesBachelor’s
Experience LevelExpert or higher

Requirements

  • 10+ years of experience with a Bachelor’s degree, or 8+ years with a post graduate degree
  • Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
  • Ability to manage multiple competing priorities with good planning, time management and prioritization skills
  • Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
  • Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports
  • Interact with key stakeholders across Clinical Development functional areas
  • Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals
  • Influence opinions and decisions of internal and external customers / vendors, across functional areas
  • Problem solving, prioritization, conflict resolution and critical thinking skills
  • Strong communication, technical writing, and presentation skills experience

Responsibilities

  • Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s)
  • Serving as the lead clinical scientist on the clinical trial team
  • Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance
  • Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on study deliverables
  • Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming
  • Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct
  • Providing tactical/scientific mentorship to other clinical scientists
  • Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)
  • Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies
  • Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs.

Preferred Qualifications

  • Experience within oncology preferred.