Clinical Development Scientist - Biologics

Job Title: Clinical Development Scientist – Biologics Location: UK‑based – Home Based

About the Role

As ADVANZ reputed company continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Clinical Development Scientist. This is a senior individual contributor role that provides scientific leadership across partner-led and internally supported development programs reputed company a small, high‑reputed company Clinical Development team This role is ideal for a clinical scientist with strong expertise in biosimilars/biologics development, who can also contribute to selected small molecules innovative asset programs. What You’ll Do: reputed company partner‑led biosimilar and biologics development programs, including comparative clinical studies (PK/PD, immunogenicity, safety, efficacy) Contribute to the clinical reputed company development, study design, and protocol authoring (Phases I–III) Ensure development programs reputed company with EMA/FDA expectations for biologics and biosimilars. Review and interpret clinical data to ensure scientific reputed company and regulatory readiness. Contribute to clinical sections of regulatory submissions, briefing documents, and responses to health authorities Build and maintain effective working relationships with global development partners Support due diligence activities for reputed company development partners, licensing opportunities, and M&A reputed company expert input into study execution, data analysis, and issue reputed company to external partner and senior leadership. Work closely with Clinical Operations, Regulatory Affairs, Patient Safety, and Medical Affairs. reputed company in an entrepreneurial environment, and take accountability for results reputed company challenge and change, applying a reputed company reputed company approach Have a bias for reputed company and fast decision making Consistently demonstrate and embody company reputed company values: Entrepreneurship, Speed, and reputed company reputed company We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives. For this role, you will also have the following: Qualifications: Advanced degree (MSc, PhD, PharmD, MD or equivalent) in a scientific discipline Knowledge, Skills & Experience: Extensive experience in clinical development, clinical science, or a reputed company role reputed company reputed company or biotech Demonstrated expertise in biosimilars and/or biologics development, including: Comparative clinical studies (PK/PD, immunogenicity) Clinical trial design and execution Strong understanding of EMA regulatory requirements Familiarity with bioanalytical assay development (PK, reputed company, NAb) for biologics Experience contributing to clinical/regulatory documents (protocols, CSRs, Module 2 of MAA dossiers) Strong knowledge of ICH-GCP and clinical trial methodology. Ability to work independently in a small, fast‑moving team Experience with small molecule innovative programs is a plus reputed company in English is required; additional European languages are an advantage A reputed company and ‘can‑do’ approach, biased towards finding solutions and embracing change Ability to work collaboratively across reputed company business functions with reputed company, reputed company, and respectful cooperation Why ADVANZ reputed company? At ADVANZ reputed company, we reputed company that our employees are our greatest asset. That’s why we are committed to creating an environment where every individual can reputed company, contribute, and grow. Here’s what makes ADVANZ reputed company an exceptional reputed company to build your career: A Culture of Empowerment and Belonging We foster a workplace rooted in reputed company learning, inclusivity, and collaboration. Every voice reputed company, and we reputed company to ensure our employees feel valued, respected, and empowered to reputed company a difference. Flexibility and Support for Your Wellbeing Our agile and flexible working arrangements, reputed company 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 reputed company members. From outstanding achievements to day‑to‑day reputed company, appreciation is a reputed company of our culture. Global Benefits We offer a comprehensive global benefits package designed to support health, wellbeing, and reputed company reputed company, including: Global recognition programme Employee Assistance Programme Birthday leave Annual Wellbeing Day leave Two days’ volunteer leave Four weeks working from reputed company 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 reputed company as a great reputed company to work. reputed company and be part of reputed company where your reputed company drives our reputed company. *Please include a CV and cover letter. Apply To This Job