Compound life cycle management:
- Executes R&D KOL management.
- Execute R&D publications based on the agreed R&D publication plan.
Development planning and execution:
- Creates, revises and maintains study design and outlines, scientific rationale, Protocol Element Document (PED) and full protocol of the clinical studies aligned with the clinical study plan.
Provides leadership to implement study protocol, knowledge transfer to JCOL, and execute clinical study oversight of clinical studies, in addition to creating and updating the following documents:
- Investigator's Brochure (IB)
- FAQ on patient eligibility or other medical issues and potential concerns during execution of clinical study in Japan.
- Summary of the compensation system for subject health injury in Japan.
- Criteria of protocol deviation, if any.
- Medical monitoring plan/medical review plan, if any.
- Statistical Analysis Plan (SAP)
- Analytical risk based monitoring plan,
- Related other documents to clinical studies
- Training materials for JCOL and study operation team involved, if any.
- Provides leadership to execute medical monitoring while conducting independent clinical study in Japan (Local study).
- Provides leadership to execute risk and feasibility assessment of full protocol of the studies including impact assessment of unapproved in Japan, out of scope in J-labelling, imported drugs regardless approval in Japan.
- Provides leadership to create Clinical Study Report (CSR) of the Local study, relevant parts of Common Technical Document (J-CTD), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
- Provides leadership to file CTD as JNDA including labeling discussion.
Post marketing activities:
- Contributes to package insert (J-labelling) development.
- Supports to develop risk management plan including post marketing surveillance studies led by JSS.
- If post marketing clinical study in Japan is considered, practical support will be necessary by JCL.
Reporting lines and talent pipelines:
- Provides feedback regarding Japan Clinical Scientists and Study Responsible Physician (in case of the Local study) to be reported to the Assoc. Dir.
- PhD in epidemiology or a closely related field OR an MD with MPH/ MS in Epidemiology or a closely related field is desirable.
- MPH or MS with more than 8 years of experience or MD/PharmD/PhD with 5 or more years of hands-on experience in the field of epidemiology, outcomes research or related discipline is required.
- Experience with writing protocols in general and particularly the statistical methods sections of study proposals for observational studies and/or proposal requests is required
- Understanding and the ability to interpret quantitative methods is required
- Experience working with large administrative or medical records databases is required
- This position will require someone who can actively collaborate with cross-functional teams.
- Pharmaceutical or Medical Device and Diagnostics industry experience is preferred
- Knowledge of local regulation such as GPSP is preferred.
- Background / experience in hematology, oncology, immunology, mental health research is preferred
- Experience working with health authorities is preferred