※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
- Exert leadership to achieve program milestones and goal of program.
- Provide development/LCM strategy for assigned programs with director JPTL's support to ensure clear goal setting and robust development/LCM plans for effective and efficient program management in accordance with the global strategy.
- Ensures that the JPT implements its plans and adheres to key milestones for assigned programs.
- Responsible for aspects of pre-clinical, CMC, clinical, LCM plans and programs across from initiation of the development in Japan through LCM.
- Leads the JPT and reviews plans for assigned programs.
- Contributes to objective setting and appraisal of core team members for program related activities
- Keeps senior management and director of JPTL informed
- Update scientific and medical knowledge including competitor situation through KOL communication and scientific literature to develop strategy.
- Minimum of five (5) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
- Has experience to have direct collaboration with global team member.
- Has experience to lead development activity as a representative of department section.
- A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.
- A thorough understanding of how to influence local regulatory and scientific environments.
- Ability to assimilate data, recognize key variables and analyze complex situations. Make quality judgments.
- Can address issues through CAPA.
- A style which builds alliance within the organization, locally/globally, and/or corporate collaborators.
- Does not confuse effort for results.
- Tenacity to weather short-term setbacks for long-term advantages.
- Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
- Has experience leading or supporting preparation of PMDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-JNDA, focusing on the key strategic issues.
- Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.