Job Advert Title: Medical Lead GU Oncology and Emerging Areas
Location: Nihonbashi, Tokyo
Division: Oncology
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
This new position is being created to hire into a new role in the Oncology Development Organization
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
• The Medical Lead GU Oncology and Emerging Areas reports to the Medical Head Solid Tumor Development and has 3 key objectives they would be expected to deliver on
- Development and implementation of the GU Oncology franchise strategy in alignment with the overall Oncology Development and One Oncology Franchise Strategy. Ensure robust life-cycle management plans are defined and executed for key GU Oncology brands. Significantly contribute to the development of the Oncology Development vision, mission, objectives, ways of working and plans. Thought partner for Medical Head Solid tumor Oncology Development
- Leading a team of physicians and development scientists to flawlessly deliver on the goals and objectives of the GU Oncology and Emerging Areas Development team. Accountable for quality in all work products of the team, ensuring efficiency in clinical development planning and execution and embedding a sense of urgency in decision making to aid pipeline progress. Ensuring robust talent assessment, development and management in the GU Oncology and Emerging Areas development team. Ensure appropriate training and sharing of specific therapeutic knowledge and innovation across the team.
- Developing and managing strong alliances with the Oncology Research, medical affairs, commercial and business development organizations to enable end-to-end execution. Provide guidance on criteria for clinical candidate selection, guidance during the pre-candidate nomination period and during development to ensure ongoing clinical stage programs are supported by Oncology Research and by Early Development and Translational Sciences as required. Define disease opportunity profiles for indications within the GU Oncology and Emerging Areas. Align with and provide support for the development of target product profiles and criteria for key decisions such as PoC and decision to invest in full development. Leading the sustainability strategy for the GU Oncology and Emerging Areas franchise and partnering with Business development to deliver on the same.
• Specific responsibilities and contributions to Astellas Clinical Development include
- Guide development of, review and approve clinical study designs, new and amended protocols for appropriate governance discussions.
- Collaborate with other Medical Leads across Oncology and Biopharma/Cell&Gene and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance/Medical Safety in the development and maintenance of medical science specific global standards, processes, SOPs, training and quality control, to the highest level of compliance with ICH, GCP and Astellas policies.
- Development, mentorship and retention of high performing development physicians and development scientists. Effectively and strategically manage the development and deployment of people resources, while ensuring optimal oversight and supervision to ensure the team is appropriately staffed with required competencies to achieve functional and enterprise objectives.
- Ensures optimal strategic and quality input and delivery in planning of clinical development strategies, execution of clinical trials and in the preparation and submission of relevant regulatory dossiers, documents, presentations, health authority responses and specialty publications in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences.
- Partner with Pharmacovigilance/Medical Safety Leads to ensure optimal standards, processing, collection and communication of human safety information, ensuring the safety of all patients receiving investigational and/or marketed Astellas products.
- Provides strategic input into the project and protocol review committees and ensures appropriate medical excellence is incorporated into study designs and participant safety is protected through appropriate selection and monitoring of patients.
- Support development and maintenance of optimal solutions for functional service provider relationships with appropriate quality and oversight to ensure flexibility and agility in the allocation and management of internal and external resources as needed.
- Contributes to the preparation of clinical program budgets in collaboration with Medical Head Solid Tumor Development. Responsible for management of their team budget including Travel and Expense.
- Participates in Oncology Leadership Teams as required to bring a Medical Sciences perspective and contribute to the strategic direction of the One Oncology Franchise.
- Ensures high quality and timely Medical Sciences review of in-licensing opportunities, out-licensing and/or multi-track business development activities relevant to GU Oncology and Emerging Areas.
• Displays the highest level of personal commitment to the Astellas code of ethics.
• Commits to the growth and organizational health of the Oncology Development Organization, and R&D at Astellas through inspiring and shared accountability.
（変更の範囲）
会社内での全ての業務
【就業環境に関する要件 / Specific Physical or Environmental Requirements】
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
【応募要件 / Qualifications】
＜必須 / Must＞
• MD/ MD-PhD. with board certification in medical or surgical oncology fields.
• 7-10 years in pharmaceutical and/ or academic setting. A minimum of 3-5 years experience in drug development in pharma or pharma, particularly in the GU Oncology and Emerging Areas.
• Clear voice, thoughts and strategy in GU Oncology and Emerging Areas development. Ability to define the vision for the disease area, communicate it to all audiences- internal and external. Excellent network and alliances with academic investigators.
• Demonstrated ability to execute clinical development strategies as evidence by prior experience with programs at all stages of development including interface with research, medical affairs and commercial. Demonstrated knowledge of regulator, payer and re-imbursement needs.
• Passionate talent developer. Serves as thought partner for function head.
• Significant people management experience. Experience hiring, leading, and retaining “best in class” medical scientists who work optimally in a cross-functional team and matrix environment.
• Experience leading both direct line and matrix team managers and individuals to develop their own problem-solving skills and discipline.
• Experience planning, allocating and managing multiple clinical project budgets as well as departmental budgeting that involves allocation of internal and external resources for 3-year strategic capacity planning.
• Experience working in global teams and a global management structure. Aware of cultural diversity and how to influence and manage in a multi-cultural organization.
＜歓迎 / Want＞
Direct experience leading global regulatory marketing authorization submissions and defense of those submissions.
【応募書類 / Application Documents】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed
【選考プロセス / Selection details】
書類選考 → 1次面接 → 適性検査 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → Aptitude test → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
（雇入れ直後）
東京都中央区 アステラス製薬 日本橋事業所 本社
Nihonbashi, Tokyo
（変更の範囲）
会社の定める事業場および自宅
【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】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
住宅手当、通勤手当 等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
8:30～17:30（月～木）、8:30～15:45（金）
裁量労働制の場合、所定労働時間を働いたものとみなす。
8:30～17:30（Mon～Thu）、8:30～15:45（Fri）
【休日 / Holidays】
完全週休２日制（土曜・日曜）、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
【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"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."
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