Clinical Development Scientist Oncology

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 Development Scientist will participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Development Physician. The role is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core expertise and experience in clinical development to enable increased participation in division and portfolio level initiatives.

Responsibilities and Accountabilities:

• Responsible and accountable for activities related to all current and planned clinical trials on assigned development programs (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting).
• Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussions and timely decision making.
• Serves on the clinical sub-team with Clinical lead, Operations Lead, and Medical Monitor/Development Physician; supports preparation of clinical development plans, site identification and management, and DESC meetings.
• Under the guidance of the development physician/med lead, performs medical monitoring activities (e.g., review, analyze, and triage patient data, generate study reports)
• Can independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plans.
• Partners with Clinical lead in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
• Together with the clinical lead and Product Responsible Person, prepares analysis for DMC/DSMB/DEC forums or regulatory submissions.
• Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs on enabling appropriate enrollment into clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical content at internal or external meetings.
• Supports engagement with current and future clinical study sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Shows relevant expertise related to Study Data Review and Analysis:
• Provides clinical input into statistical planning, data analysis, and interpretation.
• Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease- or technology-related scientific publications.
• Works closely with operations groups for site and vendor feasibility, trial set up, and data monitoring.
• Leads the execution of contracts, particularly for investigator meetings and advisories.
• Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
• Serves as key partner for the Development Division in assessment of candidates within discovery, identifying opportunities and potential risks in the context of future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
• May represent clinical development and assist with clinical assessment of new assets for potential in-licensing and acquisition.
• Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
• Performs other duties as assigned or special projects as required.

This position is typically an individual contributor role, but may have direct reports based on experience, scope, accountabilities and complexity of assigned development programs. If the position has direct reports, will align with Astellas guidelines for span of control and organizational levels.

This position reports to the IO Development Medical Lead/Head of disease area strategy.