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Job Title:

Clinical Development Scientist - Biologics

Location:

UKbased - Home Based

About the Role

As ADVANZ PHARMA 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 within a small, highimpact 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 partnerled 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, fastmoving team
• Experience with small molecule innovative programs is a plus
• Fluency in English is required; additional European languages are an advantage
• A positive and 'cando' approach, biased towards finding solutions and embracing change
• Ability to work collaboratively across all business functions with open, honest, and respectful cooperation

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 worklife balance.

Recognition That Inspires

Through our Rewards and Recognition programme, we celebrate the extraordinary contributions of our team members. From outstanding achievements to daytoday 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 now and be part of a team where your growth drives our success.

*Please include a CV and cover letter.