Clinical Leader

Clinical Leader YOUR TASKS AND RESPONSIBILITIES: Leads the Clinical Team, a cross functional team of internal experts, through clinical phase I – III trials, and global product registration. Deal with relative complex projects (e.g. co-development with another company). Sets project-related objectives with team members. Requests clinical team members and clarifies resource availability with functional heads Act as a member of the J-Project Team representing Clinical Development (CLD) and member of the Launch team, representing CLD. Build consensus by complying input from multiple functions In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP). Responsible for planning and managing the clinical timelines, against the approved CDP. Provides domestic study concepts to ensure compliance with global strategy. Proactively initiates corrective action as needed Responsible for the ongoing risk-benefit assessment of a compound until approval in Japan. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate In consultation with the Head of CLD and Global Clinical leader, responsible for assessments and communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities) Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (J-CTD Module 2s). Consults with Global clinical leader, Clinical Science, Clinical Statistics, Regulatory, PHV. Compiles and maintains Translated Investigators’ Brochures (IB) Provides medical expertise to Marketing (for marketed products and for development projects) and defines together with the Medical Affairs (MA) the publication strategy. Ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail. Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development. Provides medical assessment of in- and out- licensing opportunities of development projects Conducting Clinical Development tasks independently while seeking advice on exceptional or complex topics from senior clinical leaders and/or managers WHO YOU ARE: M.D or PhD holder is preferred with extensive professional and academic experience in relevant areas, or a person with proven equivalent background Board certification in a relevant therapeutic area is preferred but not a must Key competencies needed by the candidate include the following: In-depth understanding of the drug development and commercialization process with a base of experience of 8+ years in Medical Science / Clinical Practice and drug development (From protocol writing to Medical review report) Someone with Oncology TA experience is mandatory for this role Proven leadership, motivational and interpersonal skills Must provide clear vision, direction, and purpose in the different cultures present within RD-J as well as the global Medical Organization (e.g. for function goals, RD-J vision) Incumbent must embrace change and be able to work in a changing environment Strong communication and analyzing skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively Guide junior members adequately Native level of writing skills in Japanese (e.g. for J-CTDs/PMDA’s inquiries) Good communication skills in English (i.e. TOEIC 730 + professional working proficiency) WHAT BAYER CAN OFFER YOU: We offer a competitive salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at Bayer We provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your manager We support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participations At Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employees We provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance 採用予定日: ASAP 部門: 医療用医薬品 勤務地: 大阪または東京 職務領域: 臨床開発＆業務 ポジションの職務等級: VS 1.2 社員区分: 正社員 勤務時間: 09:00 - 17:30 連絡先: E-Mail: #J-18808-Ljbffr