Clinical Development Scientist - Biosimilars

Job Title: Lead Clinical Development Scientist – Biosimilars Location: UK - Remote Spain - Remote

About the Role

As ADVANZ PHARMA sharpens its strategic focus towards biosimilars and specialty generics, we have an exciting opportunity for a Clinical Development Scientist to join our Clinical Development team. This role will focus primarily on supporting biosimilars development programmes, working closely with internal teams and external partners to ensure partners clinical strategies and programmes are aligned with regulatory expectations and delivered at pace. This is a hands-on role within a small, high-impact team, offering exposure across clinical development strategy, trial execution, partner governance and regulatory deliverables during an exciting period of growth in the biosimilars space. What You’ll Do: Lead clinical development oversight of partner-led biosimilar programmes, including PK comparability, immunogenicity, safety, and efficacy where applicable. Contribute to clinical development strategy, including study design and programme planning Critically review biosimilar clinical development plans and study designs, ensuring they are aligned with current EMA, FDA, UK, and other relevant regulatory expectations. Review, challenge and refine clinical trial documentation and outputs across biosimilar studies (e.g. PK/PD, immunogenicity) Support preparation and review of clinical and regulatory documents, including briefing materials, submission modules, and health authority responses. Collaborate with cross-functional teams including Regulatory Affairs, Medical Affairs, Clinical Operations and Business Development to support portfolio decisions. Provide scientific input and support to ensure programmes are delivered efficiently and to high quality Contribute to a fast-paced, evolving clinical development environment About You We are looking for a Clinical Scientist with direct biosimilar experience who is ready to take ownership of scientific review and partner oversight within a growing, focused development function. . You will be comfortable working in a fast-moving environment and contributing across both clinical strategy and execution. Qualifications: Advanced degree (MSc, PhD, PharmD, MD or equivalent) in a scientific discipline Knowledge, Skills & Experience: Working experience in clinical development, clinical science, medical science, or a related role within pharma, biotech, or CRO, including direct work on biosimilar development programmes (essential). Hands-on biosimilar development experience, including clinical PK comparability, immunogenicity strategy, study conduct, data interpretation, or filing support (essential). Ability to critically assess bioanalytical and immunogenicity outputs, including PK assay suitability, ADA/NAb data interpretation, sensitivity, specificity, and clinical relevance (desirable) Experience reviewing or contributing to biosimilar clinical development plans, protocols, SAP input, CSRs, briefing books, regulatory responses, or submission documents. Practical knowledge of EMA and/or FDA biosimilar expectations, with the ability to stay current with evolving guidance. Strong understanding of clinical trial methodology from design to reporting Experience contributing to clinical and regulatory documentation Good understanding of GCP and inspection readiness Ability to work effectively in a cross-functional, matrix environment Why ADVANZ PHARMA? At ADVANZ PHARMA, we believe that our employees are our greatest asset. That’s why we are committed to creating an environment where every individual can thrive, contribute, and grow. Here’s what makes ADVANZ PHARMA an exceptional place to build your career: A Culture of Empowerment and Belonging We foster a workplace rooted in continuous learning, inclusivity, and collaboration. Every voice matters, and we strive to ensure our employees feel valued, respected, and empowered to make a difference. Flexibility and Support for Your Wellbeing Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work‑life balance. Recognition That Inspires Through our Rewards and Recognition programme, we celebrate the extraordinary contributions of our team members. From outstanding achievements to day‑to‑day excellence, appreciation is a cornerstone of our culture. Global Benefits We offer a comprehensive global benefits package designed to support health, wellbeing, and professional growth, including: Global recognition programme Employee Assistance Programme Birthday leave Annual Wellbeing Day leave Two days’ volunteer leave Four weeks working from anywhere Compassionate leave Long Service Award But don’t just take our word for it: 89% of employees in our Q1 2025 engagement survey would recommend ADVANZ PHARMA as a great place to work. Apply To This Job