Medical Director Development （Medical Doctor Oncology） / アステラス製薬株式会社
|職種||Medical Director Development （Medical Doctor Oncology）|
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: incl
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.
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.
|年収||1300万円 - 1600万円|