Overview
Clinical Scientific Liaison (CSL) Jobs in Tokyo, Tokyo, Japan at Henlius
Title: Clinical Scientific Liaison (CSL)
Company: Henlius
Location: Tokyo, Tokyo, Japan
Key Responsibilities:
- CSL will carry out feasibility activities at the study level by providing the study team with information on the medical environment and standard treatment in Japan.
- Identify opportunities for collaboration with KOLs to present at scientific forums such as national and regional specialty society meetings, as well as other strategic industry medical needs.
- Facilitate medical and scientific field intelligence that could include list of providers/ investigators in specific tumor types.
- By building good relationships with KOLs, CSL will provide expert advice to the study team from planning to execution of the clinical study.
- CSL will draft a list of sites suitable for the clinical study protocol based on CSL's knowledge and information from stakeholders (KOLs, SMOs, PROs etc.).
- CSL will support site startup activities by inputting CSL's knowledge to the study team.
- CSL will support the creation of patient recruitment plans at the study level and site level and be responsible for patient recruitment according to the patient recruitment plan per assigned site/s. CSL will contribute to the smooth execution of clinical study by providing CSL's knowledge to the study team and study sites.
- CSL will take the lead in accelerating patient recruitment in collaboration with the study team, study teams, and stakeholders.
- CSL will accompany CRAs on site visits to support answer questions from sites and oversight study quality.
- CSL will input information when creating SOPs/Wis/Manuals.
Requirement
Education:
- Bachelor’s degree, Scientific or health related field University degree – medical or para-medical (MD, Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
Experience:
- Minimum of 10 years of experience in Biotech / pharma preferably in roles including clinical science and / or medical monitoring experience
- Prior experience in oncology background preferably for Gastrointestinal Cancers and or Breast Cancer
Skills and Competencies:
- Expert knowledge on clinical development planning, clinical study execution, and preparation of CTD for Japan NDA in the oncology area
- A wide network of personnel in the oncology field, including KOLs and investigators
- Excellent communication and presentation skills and relationship management of multiple stakeholders, internally and externally, including sites, KOLs, study teams, CROs, SMOs and others
- Highly skills of searching, analytic and reporting
- Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority
- Knowledge of ICH-GCP and other applicable regulations
- Business-level English proficiency (minimum of TOEIC 750 and preferably 800 or above, or equivalent) with the ability to engage in discussions and negotiations smoothly and effectively with global team members.
