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Jobs at ADVANZ PHARMA (Now Hiring) — 4 open

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Clinical Development Scientist - Biosimilars

Coos County, Oregon, United States · Remote OK

Senior$1.3B raised

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 exciti…

Skills: Biosimilar Development, Clinical Development Strategy, PK Comparability, Immunogenicity Strategy, Regulatory Filing

ADVANZ PHARMA logoADVANZ PHARMA

Key Account Manager - Hôpital (Île‑de‑France)

France · On-site

Senior$1.3B raised

Key Account Manager – Hôpital (Île‑de‑France) Localisation : France – Territoire Île‑de‑France (Paris et région parisienne) À propos d’ADVANZ PHARMA ADVANZ PHARMA est une société pharmaceutique mondiale dont la mission e…

Skills: Business Development, Hospital Sales, Key Account Management, KOL Management, Pharmaceutical Promotion

ADVANZ PHARMA logoADVANZ PHARMA

Specialist, Validation

Mumbai City, Maharashtra, India · On-site

Senior$1.3B raised

Main purpose of role: To ensure process validation activities at the contract manufacturer has been carried out as per current GMP standards and best industry practices in line with Marketing Authorisations (MA). To obta…

Skills: Process Validation, Analytical Method Validation, GMP Standards, Gap Analysis, Risk Assessment

ADVANZ PHARMA logoADVANZ PHARMA

Senior Executive, Compliance

Coos County, Oregon, United States · Remote OK

Senior$1.3B raised

Main purpose of role: - The Quality Compliance Team within the Quality Department is responsible for ensuring Contract Manufacturing Organizations (CMOs) are provided with current Marketing Authorization information and …

Skills: Quality Compliance, CTD Module 3 Authoring, GxP Knowledge, QMS, Change Control

ADVANZ PHARMA logo

Clinical Development Scientist - Biosimilars

ADVANZ PHARMA

Coos County, Oregon, United States • Remote OK

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Senior

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  • Full-time
  • postgraduate degree
  • Global Recognition Programme, Employee Assistance Programme, Birthday Leave, Annual Wellbeing Day Leave, Volunteer Leave, Working From Anywhere (Four Weeks)
  • Posted 8d ago
  • Apply by Jul 10
  • ~40 hrs/week
  • Remote in United Kingdom, Spain

Responsibilities

Lead clinical development oversight for partner-led biosimilar programmes, focusing on PK comparability, immunogenicity, and safety. Collaborate with cross-functional teams to align clinical strategies with EMA, FDA, and UK regulatory expectations.

Requirements

Requires an advanced scientific degree and essential hands-on experience in biosimilar development programmes. Candidates must be proficient in clinical trial methodology and the preparation of regulatory submission documents.

Full job description

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.

 

 

Related keywords

BiosimilarsClinical DevelopmentPK/PDImmunogenicityEMAFDAGCPClinical Trial ProtocolSAPCSRBioanalyticalADA/NAbRegulatory AffairsMedical AffairsClinical OperationsPharma

About ADVANZ PHARMA

LinkedInVisit site

Partner of choice in specialty, hospital, and rare disease medicines

Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Headquarters
London, England
LinkedIn followers
54,490
Total funding
$1.3B

Partner of choice in specialty, hospital, and rare disease medicines ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

Offices: Dashwood House, 2nd Floor, 69 Old Broad Street, London, England EC2M 1QS, GB · Level 5, Tower-II, Phase-II, Raiaskaran Tech Park, Andheri Kurla Road, Andheri (East), Mumbai 400 072, IN · 17 Northwood House, Ormond Building, Dublin, Dublin D09 V504, IE · Bergaliden 11, Helsingborg, 252 23, SE · Level 9, 76 Berry Street, North Sydney, NSW 2060, AU

Specialtyhospitaland rare disease medicinesHospitalHealth CarePharmaceutical
View all jobs at ADVANZ PHARMA

About ADVANZ PHARMA

LinkedInVisit site

Partner of choice in specialty, hospital, and rare disease medicines

Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Headquarters
London, England
LinkedIn followers
54,490
Total funding
$1.3B

Partner of choice in specialty, hospital, and rare disease medicines ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

Offices: Dashwood House, 2nd Floor, 69 Old Broad Street, London, England EC2M 1QS, GB · Level 5, Tower-II, Phase-II, Raiaskaran Tech Park, Andheri Kurla Road, Andheri (East), Mumbai 400 072, IN · 17 Northwood House, Ormond Building, Dublin, Dublin D09 V504, IE · Bergaliden 11, Helsingborg, 252 23, SE · Level 9, 76 Berry Street, North Sydney, NSW 2060, AU

Specialtyhospitaland rare disease medicinesHospitalHealth CarePharmaceutical
View all jobs at ADVANZ PHARMA

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