Development Scientist Biopharma
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.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centres (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 behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Location and Working Environment
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’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- Lead the design, execution, and analysis of high-quality clinical studies to advance innovative therapies and support portfolio and pipeline objectives.
- Provide scientific and clinical leadership within Global Clinical Development, shaping and executing development strategies across assigned modalities or indications.
- Collaborate cross-functionally with Medical, Regulatory, Operations, Data Sciences, Research, and other partners to bridge strategy and execution, enabling informed decision-making and regulatory success.
Role and Responsibilities
- 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.
Required Qualifications
- 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.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, 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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