Medical Lead GU Oncology and Emerging Areas

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.