Astellas Pharma · 2 days ago
Development Scientist, Oncology Clinical Development
Northbrook, IL
Full-time
Hybrid
Senior Level
$180K/yr - $230K/yr
7+ years expAstellas Pharma is a pharmaceutical company dedicated to developing innovative therapies for patients. The Development Scientist will be responsible for designing and implementing clinical strategies for assigned development programs, working closely with cross-functional teams to ensure the success of clinical trials.
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
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 is acceptable
Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study start-up & execution to regulatory submissions (INDs, BLAs, NDAs) within U.S. and ex-U.S
Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations)
Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g., electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (e.g., Excel, SigmaPlot, SPSS, R, etc.)
Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV)
Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities
Knowledge of global pharmacovigilance standards and guidance documents
Comfortable working in a flexible, dynamically changing and (at times) challenging environment
Excellent strategic planning, organizational, and verbal and written communication skills
Ability to exercise sound judgment, tact, diplomacy, and professionalism in all interactions
Highest level of scientific integrity and impeccable work ethics
Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail
Able to travel ~25%, with international travel as required
Preferred
MD., PharmD, or other relevant master's degree
Knowledge and proficiency related to Immuno-Oncology clinical research
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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
Company fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
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