Job Description

• MD (Medical Doctor) or equivalent medical degree is required; specialization in internal medicine, immunology, oncology, or related fields is preferred.
• 10+ years of experience in clinical research and drug development, with at least 2 years in biosimilars or biologics preferred.
• In-depth understanding of EU clinical trial regulations, EMA biosimilar guidelines, and GCP requirements.
• Experience with Phase I–III clinical trials, including protocol design, medical monitoring, and regulatory interactions.
• Proven ability to work with cross-functional teams and manage complex clinical programs across multiple countries.
• Excellent communication, analytical, and problem-solving skills.
• Fluency in English (written and spoken); additional European languages are a plus.
• Ability to travel within Europe as required. - Provide medical leadership and strategic input for the planning and execution of biosimilar clinical trials in Europe.
• Lead the development of clinical protocols, investigator brochures, informed consent forms, and other core trial documents in collaboration with clinical operations, regulatory, and biostatistics teams.
• Oversee medical aspects of study conduct, including patient safety, medical monitoring, adverse event assessment, and protocol compliance.
• Serve as the primary medical point of contact for regulatory authorities, ethics committees, investigators, and CRO partners.
• Ensure compliance with ICH-GCP, EMA guidelines, and local regulatory requirements throughout the trial process.
• Collaborate with regulatory affairs to support submissions (e.g., CTA, MAA) and respond to health authority queries.
• Provide medical input for data analysis, interpretation of clinical results, and preparation of clinical study reports and publications.
• Contribute to the development of clinical strategies, clinical development plans, and risk management plans for biosimilar products.
• Support cross-functional communication between global headquarters, European affiliates, CROs, and external stakeholders.
• Represent the company at investigator meetings, scientific conferences, and regulatory interactions as required.

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