Senior Medical Director Therapeutic Area （Medical Doctor） / アステラス製薬株式会社
|職種||Senior Medical Director Therapeutic Area （Medical Doctor）|
・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 conju
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.
・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
・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.
|年収||1500万円 - 1800万円|