Asset Valuation, Biology, Business Development, Clinical Practices/Protocols, Clinical Trial, Continuous Improvement, Cross-Functional, Disease, Drug Development, Due Diligence, Establish Priorities, GCP (Good Clinical Practices), Healthcare, ICH Regulations, Immunology, Leadership, Licensing, Maintain Compliance, Medical Affairs, Oncology, Ophthalmology, Policy Development, Process Improvement, Publications, Regulations, Regulatory Submissions, Reporting Skills, Research & Development (R&D), Research Protocols, Standard Operating Procedures (SOP), Strategic Planning, Time Management, Urology, Women's Health
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose and Scope:
The Head of Emerging Indications is a senior leader in Oncology Medical Development, reporting to the Head of Oncology Medical Development. This "above-asset" position is accountable for shaping and executing clinical development strategy across emerging disease areas, with a strong focus on enabling enterprise growth through entry into new indications.
The role provides leadership and oversight to multiple Global Medical Leads and drives delivery excellence across a portfolio of early- and late-stage programs. This leader plays a critical role in defining future portfolio direction through disease cluster strategy and active participation in business development activities.
Responsibilities and Accountabilities:
- Portfolio Leadership and Emerging Indications Strategy
- Define and lead disease cluster strategies to enable entry into new and emerging oncology indications, aligned with enterprise priorities
- Identify and shape opportunity spaces, integrating internal and external insights
- Serve as a key thought partner in portfolio prioritization and long-term disease cluster strategy
- Drive strategic decisions to ensure sustainable portfolio growth and differentiation
- Clinical Development Leadership and Execution Excellence
- Provide oversight and direction to Global Medical Leads to ensure high-quality, timely execution of clinical programs
- Guide design, review, and governance of clinical study protocols, ensuring scientific rigor, feasibility, and regulatory alignment
- Ensure delivery of high-quality, credible data to support regulatory submissions, publications, and lifecycle strategies
- Embed a culture of accountability, urgency, and excellence in execution across programs
- Ensure optimal resource planning and deployment across the Emerging Indications portfolio
- Cross-Functional, End-to-End Leadership and Integration
- Ensure integrated, end-to-end development strategies that align with regulatory and commercial objectives through seamless collaboration across Research, Early Development, Clinical Operations, Regulatory, Quantitative Sciences, Safety, Medical Affairs, and Commercial
- Business Development and External Engagement
- Play a key leadership role in evaluation of in-licensing, out-licensing, and partnership opportunities
- Provide Medical Development expertise in due diligence, asset valuation, and integration planning
- Contribute to strategy development for multi-track business development initiatives within Oncology
- Governance, Compliance, and Operational Excellence
- Participate/Lead governance forums, providing a strong Medical Development perspective
- Ensure adherence to ICH, GCP, and Astellas policies across all development activities
- Contribute to the establishment and continuous improvement of processes and SOPs
A
Astellas Pharma Inc
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.
2,500 to 4,999 employees
Biotechnology/Pharmaceuticals
https://www.astellas.com/us/