※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] R&D Division Director
[Salary] 15〜17 million JPY ※Experiences and skills will be considered
You are responsible for providing strategic and scientific directions on the assigned therapeutic area in Japan and leading the relevant Team(s) managing a single indication across multiple assets.
You are center of KOLs and the Japanese health authorities.
You consult/support clinical operational activities from medical perspective.
Typically, you would conduct their team work as part of a GPT and under the supervision of a GPT Lead/GMT Lead.
As the accountable program(s) owner, you lead and chairs the team, leading the creation of an integrated development/lifecycle management (LCM) plan, maintaining a strategic focus and ensuring the team's commitments are met.
Your role is one of leadership, being proactive and interactive, and emphasizing partnership with all team members reporting to GPTL/GMTL and other stakeholders and consultants both within and outside R&D.
You should stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with the team.
You have negotiation and persuasion skills necessary to ensure success of the program and sets goals for the team and specific program-related goals for the Core Team members.
You are the "one voice" for the team up the line, and is the principal liaison and partner to other groups.
Principal Responsibilities you accountable for:
Program ownership in Japan with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals
Provides strategic direction and leadership in Japan for assigned programs in accordance with the global strategy. Provides development/LCM strategy and leadership for assigned programs to ensure clear goal setting and robust development/LCM plans for effective and efficient program management.
Ensures that the team implements its plans and adheres to key milestones for assigned programs.
Accountable for aspects of pre-clinical, CMC, clinical, LCM plans and programs across from initiation of the development in Japan through LCM.
Leads the team and reviews plans for assigned programs.
Contributes to objective setting and appraisal of core team members for program related activities
Keeps APJ senior management informed
Is accountable for the program budget
Ensures high performance team effectiveness
Motivate, educate and collaborate with other therapeutic area
Bachelor of pharmacology or science and/or higher with a specialty in the assigned therapeutic area, or equivalent experience with clinical development required
Total leadership experience including project management which includes leadership in more than one CTN, clinical trial management, CSR/CTD creations, J-NDA, PMDA Consultation is desirable.
Minimum of ten (10) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency.
Demonstrated experience leading drug development projects and activities in a matrixed, global organization.
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 and global regulatory, scientific and commercial environments.
Ability to assimilate data, recognize key variables and analyze complex situations. Make quality judgments.
Has a realistic expectation of the business, one's self and others.
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.
Solid understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings
Has experience leading preparation of PMDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-JNDA, focusing on the key strategic issues.
Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) - what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.
Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.
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.
Seniority Level: Director
Job Function: Health Care Provider