Head of Solid Tumor Clinical Development

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 Head Solid Tumor Development reports to the head of Oncology Development and has 3 key objectives they would be expected to deliver on:

• Development and implementation of the Oncology Solid Tumor franchise strategy in alignment with the overall Oncology Development and One Oncology Franchise Strategy. Significantly contribute to the development of the Oncology Development vision, mission, objectives, ways of working and plans. Thought partner for Head of Oncology Development

• Leading a team of physicians and development scientists to flawlessly deliver on the goals and objectives of the Oncology Solid Tumor 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 Oncology solid Tumor 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 Oncology Solid Tumor area. 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 Oncology Solid Tumor 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 Heads 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 medical leads, 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.

• Play a strategic lead role, in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences, to ensure 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.

• Play a strategic lead role in collaboration with Pharmacovigilance/Medical Safety 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.

• Leads or provides key 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.

• Participate in 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.

• Responsible for contributing to the preparation of clinical program budgets in collaboration with Asset Leads and the Head of Oncology Development. As the Medical Head, ensures cost effective development strategies. Responsible for management of Oncology Solid Tumor team budget including Travel and Expense.

• Participates in Oncology Leadership Teams 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 Oncology Solid Tumor Development.

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.

Qualifications:

Required

MD/ MD-PhD.with board certification in medical or surgical oncology fields.

10-15 years in pharmaceutical and/ or academic setting. Significant experience in drug development in pharma or pharma and/ or as a clinical investigator in academia, particularly in the Oncology Solid Tumor development space.

Clear voice, thoughts and strategy in oncology solid tumor 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 knowledge of regulator, payer and re-imbursement needs.

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.

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.

Benefits:

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

401(k) match and annual company contribution

Company paid life insurance

Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

Long Term Incentive Plan for eligible positions

Referral bonus program

Category Oncology Development

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans