基本情報

求人名 Senior Medical Director Therapeutic Area (Medical Doctor)

勤務地 Nihonbashi, Tokyo

事業部 開発

雇用形態 正社員

仕事内容

Purpose & Scope

Accountable and responsible for development and implementation of a global medical development plan on a large complex late-phase project or on a group of complex

earlier-phase projects.

Serves as global medical lead (GML) on one or multiple Astellas Pharma Global Development (APGD) Core teams including late stage and complex projects.

Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.

Responsible for the medical interface with research through regulatory authorities and the commercial organization.

Provides medical leadership on the Global Project Team and chairs the Global Clinical Team meetings.

Supports to other projects as required


Essential Job Responsibilities

Accountable and responsible for design and final recommendations in clinical development plan for their drug (s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, and Medical Affairs (Global and Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research and other line functions.

Leads the global medical team(s) to design, implement and conduct multi-phase development studies globally to support filing of successful regulatory submissions and

supplemental filings post approval.

Leads APGD medical programs when required as part of post marketing requirements.

Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Global Development Project Leader (GDPL)).

Acquires public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.

Negotiates milestones and ensures clinical development objectives are met (in conjunction with Global Project Development Leader).

Plans for resources required both within the Medical Sciences organization and in conjunction with the Global Development Project Lead (GDPL) and the Global Development Operations Lead (GDOL) to accomplish the objectives in a timely and resource-efficient fashion. This includes the number of employees and contractors needed.

Responsible, in collaboration with Clinical Sciences, for developing, recommending, adhering to the clinical development budget.

Motivates global medical team towards the common goal of submitting approvable regulatory filings (in conjunction with Global Project Development Leader).

Contributes to Global Project Team meetings.

Responsible for keeping GDPL, other project physicians, VP Global Medical Science TA Head informed of clinical progress and any critical medical issues and especially the

emerging safety profile.

Coordinates and authors protocol synopses, major protocol amendments and communicates

upcoming changes to the Vice President Global Medical Science TA Head.

Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory

submissions.

May plan and convene clinical expert panel meetings and advisory boards that provide input into drug development plans.

Presents to senior management and external audiences various medical aspects of drug development, including milestones, strategies, and recent data and anticipate obstacles to or changes to approved plans.

Incorporates Health Economics Outcomes Research requirements into protocol design.


【Qualifications】

The candidate must be a strong physician scientist with several years of experience in the global pharmaceutical industry.

Capable of designing and executing clinical development plans, providing medical leadership to a project team and to junior medical staff, providing clear updates on progress to milestones and strong medical and product development acumen to programs and the team.


Required

Medical Degree (or Medically Qualified) with post graduate qualification and specialization in the appropriate specific therapeutic area/or one of the groups preferred

Should have at least 5 years relevant experience in drug development in a biotech/ pharmaceutical company or equivalent experience in an academic clinical research role

(NCI, NIH, Academic Research groups etc)

Proven record of being a successful medical leader and a study clinician.

Experience managing drug development programs.

Experience designing, implementing and conducting clinical studies, to produce both timely and high quality data.

Proven ability to get results in a matrixed management environment


Preferred

Additional post-doctoral training or additional qualifications such as PhD, PharmD, certificate in

Pharmaceutical Medicine highly desirable

Prior experience in leadership role in EU/US regulatory filing



【勤務地 / Location】

  東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo


【勤務開始日 / Start Date】

応相談

Will be decided according to the candidate's flexibility


【契約期間 / Contract Duration】

期間の定めなし

Not limited to specified period


【試用期間 / Probation Period】

試用期間原則なし

No probation period in principle


【給与 / Salary】

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000~100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

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】

年一回

Once a year


【賞与 / Bonus】

年2回(7月、12月)

Twice a year (July, December)


【諸手当 / Allowance】

住宅手当、通勤手当 等

Housing allowance, Commutation allowance, etc. 


【勤務時間 / Working Hours】

管理監督者 8:45~17:45(月~木)、8:45~16:00(金)

Managers and Supervisors 8:45~17:45(Mon~Thu)、8:45~16:00(Fri)


【休日 / Holidays

完全週休2日制、祝日、5月1日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays


【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.


【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

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


【問い合わせ先】 

アステラス製薬株式会社 人事部 採用担当 

※本職種についてのご質問は、上記の連絡先までお問い合わせください。 


"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."