Description
We are seeking a Clinical Research Physician to contribute towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.
The successful candidate will design a development strategy for multiple protocols designed to obtain approval particularly in Japan and other countries in Asia for a compound or group of compounds.
Protocol Design and Strategy:
- Contribute towards the medical input during protocol development and updates to the clinical development plan.
- Work closely with other clinicians and Japan study team members to ensure that documents meet regulatory requirements and company policy.
- Provide medical input into country feasibility.
Accountable for Safety Across the Study:
- Provide study team with medical advice for all medical issues during risk assessment and mitigation planning.
- Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP).
- Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
Support Study Team:
- Provide clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning.
- Contribute to contract research organization/vendor selection.
- Work with study team to ensure high quality of data.
Supports the Program Team:
- Work closely with Japan development teams providing medical input and knowledge throughout the program.
- Author clinical sections of regulatory documents.
- May co-author abstracts, posters, presentations and publications.
Interact with Regulatory Authorities, Key Opinion Leaders, and Principal Investigators:
- Support Clinical Regulatory Authority interactions, particularly with the PMDA.
- Liaise with Key Opinion Leaders and Principal Investigators in countries.
Qualifications:
- Medical degree (M.D or equivalent).
- Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year.
- Possesses the ability to critically evaluate medical/scientific information.
- Excellent written and oral communication in English and Japanese.
- Understands the design, development, and execution of clinical programs and studies.
- Capacity to adapt to a fast-paced and changing environment.
Preferred/Nice to Have:
- Documented work experience/knowledge of statistics.
- Training and experience in infectious diseases and/or infection control in the hospital setting.
- Experience with investigational clinical trials.
- Flexibility to join frequent late-night/early morning teleconferences with international study teams.
- Ability to travel domestically or internationally occasionally as required.