Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices.
Role purpose:
The Medical Lead Biosimilars is a hybrid Medical Affairs role combining UK-wide field-based scientific engagement with head-office Medical Advisor responsibilities. The role provides high-quality, non-promotional scientific exchange across oncology, dermatology, respiratory, ophthalmology and bone health; generates actionable medical insights; contributes to portfolio medical strategy and evidence generation; and partners closely with cross-functional colleagues to support scientifically robust, patient-focused decision-making. As the designated final medical signatory for the biosimilars portfolio, the role independently approves promotional and non-promotional materials, advisory boards and other relevant activities in accordance with the ABPI Code of Practice, applicable law, company procedures and governance standards.
Accountability:
- Act as the designated final medical signatory for the biosimilars portfolio, applying independent medical judgement to certify promotional materials, non-promotional materials, advisory boards and other relevant activities under the ABPI Code of Practice.
- Deliver credible, balanced and non-promotional scientific exchange with UK healthcare professionals and key opinion leaders, responding accurately to unsolicited scientific and clinical questions within role remit.
- Translate field intelligence and stakeholder insights into clear recommendations that inform medical strategy, evidence priorities, education plans and cross-functional decision-making.
- Provide expert medical input throughout the development and execution of portfolio activities across oncology, dermatology, respiratory, ophthalmology and bone health, without compromising the independence of Medical Affairs.
- Maintain high standards of medical governance, ethical conduct, documentation quality and compliance with company policies, pharmacovigilance requirements and relevant UK and European regulations.
- Build effective partnerships with Marketing, Market Access, Sales, Regulatory, Pharmacovigilance, Quality and regional/global Medical colleagues while maintaining clear functional boundaries and scientific integrity.
- Represent Celltrion Healthcare UK Ltd at advisory boards, scientific meetings and congresses, ensuring accurate scientific communication and timely internal dissemination of relevant insights.
- Support appropriate evidence-generation and medical education activities, including investigator-initiated study proposals, real-world evidence initiatives, publications and educational programmes.
Expenditure Responsibilities:
Plan and manage assigned Medical Affairs activity budgets and external-service expenditure within approved limits, ensuring appropriate contracting, fair market value, purchase-order discipline and accurate forecasting. This role has no people-management budget.
Authority:
Holds independent authority and accountability to approve, reject or require amendment of materials and activities submitted for final medical certification. May stop or escalate any activity where scientific accuracy, patient safety, ethical standards, legal requirements, company policy or ABPI Code compliance is in doubt. Has no line-management or matrix-management authority.
Key Responsibilities:
- Develop and execute the UK medical plan for the assigned biosimilars portfolio, aligning medical objectives, stakeholder engagement, evidence generation and education with organisational priorities and identified patient needs.
- Plan and conduct focused scientific engagement with national, regional and local KOLs, investigators and relevant healthcare professionals; establish trusted professional relationships based on scientific value and transparency.
- Capture, analyse and communicate field and congress insights promptly through approved systems, identifying trends, unmet needs, evidence gaps, risks and opportunities for the medical plan.
- Undertake UK-wide field activity, typically including 1–2 KOL field visits per month, with additional travel for key UK congresses and important international congresses as business needs require.
- Work from the Uxbridge head office one day per week, aligning the office day with the attendance of key internal stakeholders, particularly Marketing, to enable effective review, planning and cross-functional collaboration.
- Provide timely medical review and final certification of promotional materials, non-promotional materials, advisory boards and other relevant activities, documenting clear rationale and practical remediation where standards are not met.
- Partner with Marketing from concept to implementation to improve scientific accuracy, balance and review quality, while preserving the signatory’s independent judgement and avoiding inappropriate promotional influence.
- Provide expert medical input to local commercial, market-access, formulary and stakeholder plans, ensuring claims and scientific narratives are accurate, substantiated, balanced and appropriate for the intended audience.
- Lead or support advisory boards and other external expert meetings, including objective setting, agenda and content review, appropriate contracting and fair market value processes, briefing, facilitation, insight capture and compliant follow-up.
- Act as the primary Medical Affairs contact for appropriate investigator enquiries; assess and support investigator-initiated study proposals and other evidence-generation activities through established governance processes.
- Contribute to real-world evidence plans and publication activities, working with internal and external partners to address prioritised evidence gaps and communicate data responsibly.
- Create and deliver high-quality scientific training, clinical-data updates and medical education for internal colleagues, new starters and approved external audiences, including designated homecare nursing teams where required.
- Support responses to medical information enquiries and ensure adverse events, product complaints and other safety information are recognised and reported within required timelines and procedures.
- Maintain current knowledge of the ABPI Code of Practice, relevant legislation, clinical evidence, treatment pathways, competitor landscape and developments in biosimilars and assigned therapy areas.
- Collaborate with regional and global Medical teams, sharing UK insights and best practice and representing the UK medical perspective in relevant forums.
- Maintain complete, accurate and timely records of stakeholder interactions, approvals, insights, activities and expenditure in approved company systems.
Work Experience Requirements:
- UK-registered physician with a current GMC registration or UK-registered pharmacist with a current GPhC registration. This is mandatory for ABPI Code final medical signatory eligibility.
- Currently holds ABPI Code final medical signatory status.
- Minimum of two years’ experience working in Medical Affairs within the pharmaceutical or biotechnology industry.
- Minimum of two years’ experience operating as a final medical signatory, with demonstrable experience of independently reviewing and certifying promotional and non-promotional materials and activities.
- Demonstrable working knowledge of the current ABPI Code of Practice, UK medicines legislation and relevant Medical Affairs governance requirements.
- Proven experience of field-based scientific engagement and developing credible professional relationships with KOLs and healthcare professionals.
- Experience contributing to medical plans, insight generation, advisory boards, medical education and cross-functional brand or portfolio teams.
- Experience in biosimilars, biologics or one or more relevant therapy areas is desirable: oncology, dermatology, respiratory, ophthalmology or bone health.
- Excellent written and verbal English, scientific communication, presentation, facilitation and influencing skills.
- Able to work independently, prioritise competing deadlines and deliver high-quality outcomes in a fast-moving environment.
- Strong business acumen and a collaborative approach, with evidence of effective partnership across Medical, Marketing, Market Access, Sales, Regulatory, Pharmacovigilance and Quality.
- Eligible to work in the UK and able to undertake the travel required by the role.
Core Competencies:
- Independent medical judgement and final-signatory accountability
- Scientific credibility and evidence-based communication
- Ethical leadership, integrity and patient focus
- Strategic thinking and disciplined execution
- KOL engagement, active listening and insight generation
- Cross-functional collaboration with clear governance boundaries
- Critical appraisal, attention to detail and risk-based decision-making
- Influence without authority and confident constructive challenge
- Adaptability, resilience and effective prioritisation
- Clear written, verbal, presentation and facilitation skills
- Commercial awareness balanced with Medical Affairs independence
- Inclusive behaviours and effectiveness across culturally diverse teams
Celltrion Values:
- Compliance with Principles
- The Pursuit to Be the World’s Best
