Clinical Operations Development Lead

Ready to lead global clinical programs that shape the future of patient care while driving development strategy from early planning through execution?

Proclinical is seeking a Global Clinical Program Lead for a fully remote position based anywhere in BE, EU. This role is strategically important within global clinical development and combines clinical development strategy, program oversight, and cross-functional leadership. You will play a pivotal role in shaping and executing the clinical development strategy for an assigned indication or asset, working closely with cross-functional teams such as Medical Development, Regulatory Affairs, and Project Management.

Responsibilities:

• Co-lead the cross-functional Clinical Development Team alongside the Medical Development Lead.
• Co-own the Clinical Development Plan, ensuring its alignment and execution.
• Provide strategic Clinical Operations leadership for assigned indications or clinical programs.
• Align the Clinical Development Plan with the Target Product Profile and broader asset strategy.
• Oversee global clinical trials, ensuring alignment with timelines, budgets, and quality standards.
• Manage clinical trial budgets and contribute to resource, timeline, and financial planning.
• Identify program risks, develop mitigation strategies, and oversee their implementation.
• Ensure consistency and efficiency across trial setup, country/site selection, and study conduct.
• Participate in CRO/vendor selection, governance, and performance management.
• Act as a senior escalation point for operational issues in clinical trial management.
• Contribute to regulatory-critical documents and interactions with health authorities.
• Ensure audit and inspection readiness across assigned programs and trials.
• Assume direct Clinical Trial Manager responsibilities for selected studies, if required.
• Lead and develop Clinical Trial Managers and Clinical Trial Associates, where applicable.

Key Skills and Requirements:

• Degree in medicine, biology, biomedical sciences, pharmacy, veterinary medicine, or a related field.
• Extensive experience in Clinical Development or Clinical Operations.
• Background in clinical monitoring and local/global trial management.
• Proven leadership experience in global Clinical Operations within the pharmaceutical or biotechnology industry.
• Expertise in managing complex clinical programs across multiple countries and stakeholders.
• Strong understanding of global drug development and the clinical development lifecycle.
• Experience with outsourced models, including CRO/vendor oversight.
• Knowledge of ICH-GCP and international regulatory requirements.
• Proficiency in managing clinical trial budgets, timelines, resources, and operational escalations.
• Strong cross-functional leadership and stakeholder management skills.
• Ability to balance strategic program-level perspectives with operational details.
• Excellent written and verbal communication skills in English.
• Experience in rare disease, autoimmune, or immunology clinical trials is advantageous.
• Previous line-management experience is a plus.

If you are having difficulty in applying or if you have any questions, please contact Alexey Badulin at a.badulin@proclinical.com.

Apply Now:

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