Astellas Pharma · 1 month ago
Development Scientist, Oncology Clinical Development
Northbrook, IL, 60062, United States
Full-time
Hybrid
Mid, Senior LevelAstellas Pharma is a pharmaceutical company committed to developing innovative therapies for patients. The Development Scientist will participate in clinical strategy development and be accountable for the design, implementation, monitoring, and analysis of clinical studies within assigned programs.
BiotechnologyHealth CareMedical
Responsibilities
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
Qualification
Required
Core expertise and experience in clinical development
Ability to independently lead working groups and/or sub-team initiatives
Experience in developing protocols, investigator brochures, CRFs, informed consents, and clinical study reports
Expertise in synthesizing/contextualizing data to facilitate discussions and decision making
Experience in medical monitoring activities including review, analysis, and triage of patient data
Ability to prepare analysis for DMC/DSMB/DEC forums or regulatory submissions
Experience in providing training at investigator meetings and site initiation visits
Experience in engaging with clinical study sites
Expertise in Study Data Review and Analysis
Experience in providing clinical input into statistical planning, data analysis, and interpretation
Ability to support publication of data and scientific publications
Experience in working closely with operations groups for site and vendor feasibility, trial set up, and data monitoring
Ability to execute contracts for investigator meetings and advisories
Experience in developing strategic partnerships with Key External Experts (KEEs)
Ability to assess candidates within discovery and identify opportunities and risks
Experience in clinical assessment of new assets for potential in-licensing and acquisition
Ability to support strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio
Ability to perform other duties as assigned or special projects as required
Ability to align with Astellas guidelines for span of control and organizational levels if the position has direct reports
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
Founded in 2005
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase