Development Scientist Biopharma
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
As a Development Scientist, you will play a critical role in shaping and executing clinical development strategies that advance Astellas’ innovative therapies across assigned modalities or indications. This role exists to ensure the successful design, delivery, and analysis of high-quality clinical studies that support portfolio and pipeline objectives.
Working within the Global Clinical Development organization, you will collaborate closely with Global Medical Leads, Operations Leads, Medical Monitors, and cross-functional partners across Regulatory, Medical Affairs, Data Sciences, and Research. You will provide scientific and clinical leadership across development programs, bridging strategy and execution to enable sound decision-making and regulatory success.
At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Key Activities for this role:
- Lead and support the design, execution, monitoring, and analysis of clinical trials across early and/or late phase development programs.
- Develop, review, and contribute to key clinical documents including protocols, investigator brochures, CRFs, informed consent forms, and clinical study reports.
- Serve as a core member of the clinical sub-team, partnering with Global Medical Leads, Operations Leads, and Medical Monitors to support clinical development plans and study execution.
- Provide clinical and scientific expertise to synthesize and contextualize data, enabling timely and informed decision-making across cross-functional teams.
- Support medical monitoring activities under the guidance of the study physician or medical lead, including review, analysis, and reporting of patient data.
Essential Knowledge & Experience:
- Advanced degree in a relevant scientific, clinical, or health discipline with a solid experience in industry environment.
- Demonstrated expertise in clinical drug development across the full lifecycle, from study design through regulatory submission (INDs, BLAs, NDAs).
- Strong ability to collaborate and communicate effectively with internal stakeholders across Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, and Pharmacovigilance.
- Experience engaging with external stakeholders, including investigators, key external experts, and health authorities.
- Ability to work independently in a dynamic, global environment with sound judgment, professionalism, and high scientific integrity.
Preferred Qualifications:
- PhD, PharmD, MD, DO, OD, or other relevant Master’s degree.
- Experience working in Gene and Cell Therapy studies/drug development
- Experience supporting Health Authority interactions, advisory boards, and data review committees (e.g., DMC/DSMB).
- Hands-on experience with clinical data review, interpretation, and contribution to publications or scientific presentations.
Qualifications:
- Bachelor’s degree or equivalent; advanced degree strongly preferred in a scientific, clinical or health-related field.
- Strong analytical and strategic thinking skills with the ability to interpret complex clinical data.
- Proven ability to manage multiple priorities across development programs in a fast-paced, global environment.
- Excellent written and verbal communication skills with the ability to engage diverse stakeholders.
Additional Information:
- This is a permanent, full-time position.
- This position is based in Warsaw (Poland)
- This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office
Astellas’ Global Capability Centres – Overview:
Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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