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.
Development Scientist (Director)
We seek passionate individuals who thrive in dynamic environments, embrace new ideas, and are not afraid to take intelligent risks. They must act with unwavering integrity and be deeply committed to making a tangible impact.
Location and Working Environment
This hybrid position requires onsite presence 1 day per quarter at the Bourne office in London, UK, with the flexibility to work from home on other days.
Reports to the Global Medical Portfolio Lead, GU and Emerging Areas.
The Opportunity
The Development Scientist will join a diverse and agile team and contribute to the development of clinical strategies for assigned modalities or indications within the division. The role involves designing, implementing, monitoring, and analysing clinical studies, and collaborating closely with global leads and physicians.
Responsibilities
- Lead and manage all current and planned clinical trials, from protocol development to study reports.
- Provide expertise to cross‑functional team members to synthesize data and facilitate timely decision making.
- Serve on the clinical sub‑team with the GML, Operations Lead, and Medical Monitor/Development Physician, supporting preparation of clinical development plans, site identification, and DESC meetings.
- Perform medical monitoring activities, including reviewing, analysing, and triaging patient data and generating reports.
- Lead working groups or sub‑team initiatives for protocols, disease areas, or clinical development plans.
- Partner with the GML in preparing for Health Authority meetings and addressing inquiries.
- Prepare analyses for DMC/DSMB/DEC forums or regulatory submissions.
- Provide training at investigator meetings and site initiation visits, collaborating with Clinical Operations and Medical Affairs.
- Collaborate cross‑functionally to create, review, and present clinical slides for internal and external forums.
- Engage potential and current sites (e.g., SIVs, investigator meetings, conferences, steering committees, advisory board meetings).
- Provide clinical input into statistical planning, data analysis, and interpretation.
- Lead or support publication of data (manuscripts, presentations) and related scientific communications.
- Work closely with operations for site and vendor feasibility, trial set‑up, and monitoring.
- Lead or support contract execution for investigator meetings and advisories when required.
- Support development of strategic partnerships with Key External Experts.
- Represent development in clinical assessments for due diligence of new assets.
- Support strategic initiatives related to assigned molecules or portfolio, as requested.
- Perform other duties or special projects as assigned.
Essential Knowledge & Experience
- Proven experience and core knowledge of clinical development across the lifecycle, from early‑stage design to regulatory submissions.
- Independent leadership of working groups or sub‑team initiatives.
- Deep understanding of the biotechnology/pharmaceutical industry and global regulatory agencies.
- Scientific research or clinical practice experience, evidenced by qualifications, publications, or accreditations.
- Proficiency with MS Office Suite and industry‑standard software (e.g., RAVE, InForm, SigmaPlot, SPSS, R).
- Strong collaboration and communication skills to engage with stakeholders across Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, and more.
- Experience presenting to key external stakeholders and health authorities.
- Knowledge of global pharmacovigilance standards and guidance documents.
- Ability to thrive in a flexible, dynamic environment.
- Excellent strategic planning, organizational, and written and verbal communication skills.
- Judgment, tact, diplomacy, and professionalism in all interactions.
- Awareness of cultural diversity and the ability to influence and manage in a multi‑cultural setting.
- Highest level of scientific integrity and work ethics.
Preferred Qualifications / Experience
- Ph.D., PharmD or other relevant Master’s degree.
- Extensive experience in solid tumours – lung, colorectal, pancreatic cancers, biologics or immuno‑oncology.
Education
- Advanced degree in a relevant scientific discipline, health science or clinical discipline with extensive clinical, scientific/research or industry experience.
Additional Information
- Permanent full‑time position based in the UK.
- Hybrid working model: minimum 1 day per quarter onsite, with flexibility for home work.
- Travel up to ~25%, including international travel.
What Awaits You at Astellas
- Global collaboration with a connected business of like‑minded leaders.
- Real‑world patient impact through transformative therapies.
- Relentless innovation fostering future healthcare.
- A culture of growth and support for professional development.
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. Authentic communication will originate from an official Astellas LinkedIn profile or a verified company email address. Report suspicious profiles to LinkedIn support.
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