|部署・役職名||【日本発のグローバル製薬企業】Medical Director, Development （Medical Doctor, Oncology）|
【Purpose ＆ Scope】
－Accountable and responsible for development and implementation of a global medical development plan on an early to late－phase project.
－Serves as global medical lead （GML） on early stage project or at the indication study level for a larger/complex/multi－indication program.
－Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.
－Responsible for the medical interface with drug discovery, regulatory and commercial colleagues.
－Provides medical leadership on the Global Project Team and may chair the Global Clinical Team meetings; collaborates with other project team members and study team（s） to ensure delivery and quality of clinical trials.
【Essential Job Responsibilities】
－Fulfills the role of Global Medical Lead （GML） and is a member of the APGD Core Team.
－Responsible for design and recommendations of the clinical development plan（s）, after soliciting appropriate input and review from Medical and Clinical Operations colleagues as well as other contributing line functions （Regulatory Affairs, Statistics. Clinical Operations, Commercial）.
－Leads the medical team for assigned clinical trials to design, implement, conduct and interpret clinical studies to support decisions to advance or halt development of a new drug or to successful filing regulatory submissions.
－Responsible for execution and delivery of the clinical development plan.
－Acquires publicly available knowledge of competitor products and clinical plans.
－Negotiates milestones and ensures clinical development objectives are met.
－Motivates global clinical team towards the common goal of submissions of approvable regulatory filings or next clinical milestone.
－Attends important meetings with the FDA, PMDA and, as needed, with regulatory agencies worldwide.
－Contributes to Global Project Team meetings.
－Responsible for keeping GDPL, other project physicians and VP Global Medical Science TA Head informed of clinical progress and any critical clinical issues and especially the emerging safety profile.
－Contributes to clinical documents: protocols, IBs, study reports, statistical analysis plans, publications, CSRs and clinical sections of regulatory submissions.
－Responsible for clinical expert panel meetings and advisory boards to give input on clinical plans
－Presents to senior management and external audiences on clinical aspects of compound development: including milestones, strategies, recent data.
－Incorporates Health Economics Outcomes Research requirements into protocol design.
【勤務地 / Location】
【勤務開始日 / Start Date】
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration】
Not limited to specified period
【試用期間 / Probation Period】
No probation period in principle
【給与 / Salary】
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.（50,000～100,000yen, based on the Grade）
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【昇給 / Salary Raise】
Once a year
【賞与 / Bonus】
Twice a year （July, December）
【諸手当 / Allowance】
Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
Managers and Supervisors 8:45～17:45（Mon～Thu）、8:45～16:00（Fri）
【休日 / Holidays】
Weekends（Sat and Sun）, holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave】
Annual paid leave, childcare leave system, nursing care leave system, etc.
【福利厚生 / Welfare】
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
【必須（MUST）】－Medical Degree （MD） or Medically Qualified with post graduate qualification and specialization in appropriate therapeutic specialty preferred.
－Should have at least 3 years relevant experience in drug development at a biotech/pharmaceutical company or the equivalent experience at an academic clinical research （NCI, NIH, Academic Research groups etc.
－Significant and demonstrable working－knowledge of regulatory procedures and guidelines in all regions （global scope）.
－Proven track record in clinical study design, monitoring and execution and results analysis.
－Has demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data.
－Proven record of working on teams and in a matrix environment.
－Proven ability to get results in a matrix management environment.
【歓迎（WANT）】－Additional post doctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine.
－Prior experience in leadership role in PMDA/EU/US regulatory filing.
－Experience in development and implementation of global clinical trials for the registration and support of NMEs worldwide.
|アピールポイント||自社サービス・製品あり 日系グローバル企業 女性管理職実績あり 上場企業 従業員数1000人以上 シェアトップクラス 創立30年以上 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実|