Clinical Development Scientist - Biologics

Advanz Pharma

Remote, United Kingdom

This is a senior individual contributor role that provides scientific leadership across partner-led and internally supported development programs within a small, high‑impact 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:

Oversee partner‑led biosimilar and biologics development programs, including comparative clinical studies (PK/PD, immunogenicity, safety, efficacy);
Contribute to the clinical strategy development, study design, and protocol authoring (Phases I–III);
Ensure development programs align with EMA/FDA expectations for biologics and biosimilars;
Review and interpret clinical data to ensure scientific integrity 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 future development partners, licensing opportunities, and M&A;
Provide expert input into study execution, data analysis, and issue resolution to external partner and senior leadership;
Work closely with Clinical Operations, Regulatory Affairs, Patient Safety, and Medical Affairs;
Thrive in an entrepreneurial environment, and take accountability for results;
Embrace challenge and change, applying a growth mindset approach;
Have a bias for action and fast decision making;
Consistently demonstrate and embody company core values: Entrepreneurship, Speed, and Integrity.

About You:

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 related role within pharma 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, ADA, 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;
Fluency in English is required; additional European languages are an advantage;
A positive and ‘can‑do’ approach, biased towards finding solutions and embracing change;
Ability to work collaboratively across all business functions with open, honest, and respectful cooperation.