Medical Lead GU Oncology and Emerging Areas at Astellas in Northbrook, Illinois

Job Description:

Medical Lead GU Oncology and Emerging Areas

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This new position is being created to hire into a new role in the Oncology Development Organization

Essential Job Responsibilities:

• 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.