Clinical Operations Development Lead

Lead Global Clinical Programs and Drive Development Strategy

Take the lead in shaping the future of patient care by driving development strategy from early planning through execution. This strategically important role within global clinical development 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.

Key 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.