・Supervises PKS-J members to design PKS strategy for assigned program(s) and coordinate pharmacokinetic / drug metabolism related elements for pre-clinical and/or clinical projects, and identify potential project hurdles, provide solutions and establish contingency plans
・Reviews and provides scientific, strategic, and regulatory input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, BB, CTNs and NDAs within agreed timelines.
・Recruits, coaches and develops talents in PK Sciences discipline in Japan.
・Is responsible for resource planning, management, and administration in Japan to ensure project team needs are appropriately addressed.
・Independently represents PK Sciences a core member of TM-J leadership team and relevant decision making bodies in Japan.
・Leads cross-departmental teams, department-wide initiatives and work streams.
・Provide PK Sciences expertise on due diligence and prepare appropriate documentation.
・Publishes internally and externally as main contributor to enhance Company and PK Sciences visibility.
・Completes all required organizational trainings and requirements according to corporate timelines.
・Adheres in strict accord to the appropriate SOP and GxP guidelines.
・Ensures that a timely and effective communication and escalation process is communicated to and followed by all personnel in their respective area.
・Advocates continuous improvement of quality.
・Ensures all activities of associates comply with company standards and local regulations.
・Ensures adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
・100% timely delivery of all training requirements including compliance.
・PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic back ground.
・Fluent Japanese (oral and written) Fluent English (oral and written)
・10 + years of experience in drug discovery, development or a relevant environment (e.g. Clinical Pharmacology or Drug Metabolism and Pharmacokinetics).
・Extensive and in-depth knowledge of drug metabolism and pharmacokinetics including, pharmacology PK and PK/PD evaluation, Immunogenicity (for PTM roles), techniques, experience in working in project teams (preferably global) and knowledge of regulatory requirements.
・Demonstrated success of working in cross functional project teams (preferably global) and sound awareness of recent developments in drug development sciences.
・Knowledge of regulatory requirements and experience in dealing with regulatory authorities and experience conducting due diligence.
・Proficient with full range of techniques used in job and core area. Working knowledge of tools and processes used in drug design and development.
・Extensive library research skills and knowledge of problem-solving techniques.
・Extensive and in-depth knowledge of science
- Full time
- 13 million yen ～ 15 million yen
- Social insurance
Full 2 holiday week system (Sat/Sun) national holidays
New year’s holiday