Development Scientist, Oncology Clinical Development

Development Scientist, Oncology Clinical Development

Join Astellas Pharma as a Development Scientist focused on oncology clinical development. This role is based in Northbrook, Illinois and supports hybrid work in select U.S. states per Astellas’ Responsible Flexibility Guidelines.

The Development Scientist participates in developing clinical strategies for assigned modalities or indications within the division. Working closely with the Global Medical Lead, Operations Lead, Asset Lead, and Development Physician, the scientist designs, implements, monitors, and analyzes clinical studies within the assigned program. Independence, core expertise in clinical development, and proactive participation across division and portfolio initiatives are essential.

• Accountable for all current and planned clinical trials on assigned programs (protocols, investigator brochures, CRFs, informed consents, study reports, document reviews, analyses, and reporting).
• Provide expertise to cross‑functional team members for data synthesis, contextualization, and timely decision‑making.
• Serve on the clinical sub‑team with Clinical Lead, Operations Lead, and Medical Monitor/Development Physician; support clinical development plans, site identification and management, and DESC meetings.
• Perform medical monitoring activities (review, analyze, triage patient data, generate study reports) under guidance of the development physician/medical lead.
• Lead working groups or sub‑team initiatives in support of protocols, disease area, or clinical development plans.
• Partner with Clinical Lead in preparing for Health Authority meetings and address HA inquiries.
• Prepare analysis for DMC/DSMB/DEC forums or regulatory submissions with the clinical lead and Product Responsible Person.
• Provide training at investigator meetings and site initiation visits; collaborate with Clinical Operations and Medical Affairs on enrollment.
• Engage current and future clinical study sites (SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Offer expertise in Study Data Review and Analysis; provide clinical input into statistical planning, data analysis, and interpretation.
• Lead clinical leadership and support for publication of data (manuscripts, presentations, disease‑ or technology‑related scientific publications).
• Work closely with operations groups for site and vendor feasibility, trial set‑up, and data monitoring.
• Execute contracts, particularly for investigator meetings and advisories.
• Support development of strategic partnerships with Key External Experts (KEEs).
• Act as key partner for the Development Division in assessing candidates within discovery and identifying opportunities and risks based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
• Represent clinical development and assist in clinical assessment of new assets for potential in‑licensing and acquisition.
• Support strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
• Perform other duties as assigned or special projects as required.
• Typically an individual contributor; may have direct reports based on experience, scope, and complexity of assigned development programs.

• Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7–8 years clinical, scientific/research, pathology, or industry experience; combination of academia and industry acceptable.
• Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early‑stage development through approval) from initial study design to regulatory submissions within U.S. and ex‑U.S.
• Experience in scientific research and/or clinical practice (evidenced by appropriate qualifications, publications, and/or relevant accreditations).
• Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams, MS Project) and industry‑standard software (e.g., electronic data capture systems [RAVE, InForm]) and proficiency in data analysis software (Excel, Sigma Plot, SPSS, R).
• Strong…