Requirements: English
Company: WhatJobs
Region: Pratteln , Basel-Landschaft
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Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need.
Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:
Head Clinical Operations
Scope of Work
Santhera Pharmaceuticals is seeking a hands-on, forward-thinking Head of Clinical Operations to lead and grow a high-performing function in a fast-paced, mission-driven environment. This role reports to the Chief Medical Officer and is a key member of the CMO Leadership Team. You will be responsible for leading the strategy and operational execution of clinical programs across company-sponsored and partner-sponsored studies. This is a pivotal role for an experienced professional who brings the discipline and scalability of large pharma with a demonstrated ability to thrive and drive impact within the agility of a small biotech.
Please note: This is a one-year temporary contract position with the possibility of extension or conversion to a permanent role.
Key Responsibilities
- Lead the end-to-end operational execution of Santheras clinical development plans, aligning with corporate objectives and adapting to evolving strategic priorities.
- Drive excellence in study conduct across company-sponsored trials and studies sponsored by development or commercial partners in international geographies.
Leadership & Team Development
- Develop, coach, and inspire a high-performing team of Clinical Trial Leaders, Managers, and Associates to ensure effective and timely delivery of global clinical studies.
Operational Excellence & Performance Metrics
- Establish and monitor key performance indicators and metrics to ensure robust execution, budget adherence, and high-quality trial outcomes.
- Continuously assess, optimize, and redesign key operational processes and tools to drive efficiency, scalability, and quality across the portfolio.
Compliance & Quality Assurance
- Ensure full compliance with GCP, regulatory requirements, and internal quality standards, fostering audit readiness and process ownership.
- Proactively identify risks and lead mitigation strategies to navigate operational and strategic challenges throughout study execution.
- Manage vendor relationships, including CROs and clinical service providers, ensuring clear accountability, quality delivery, and contract adherence.
- Represent Clinical Operations in interactions with partners, regulatory agencies, and external stakeholders as required.
Cross-functional Collaboration
- Collaborate cross-functionally with Regulatory Affairs, Quality, Medical Affairs, and Development teams to ensure operational strategies support clinical and regulatory goals.
Clinical Operations Forecasting & Financial Management
- Lead the creation, management, and monitoring of the Clinical Operations budget, including forecasting, accruals, and variance analysis.
- Ensure optimal allocation of resources across clinical operations activities to align with clinical development plans, corporate goals and maximize delivery of programs.
- Collaborate with Finance and Procurement to manage external vendor contracts and track expenditures within approved limits.
Required Qualifications & Experience:
- Advanced degree in life sciences (BSc, MSc, PharmD, MD, PhD); higher degrees preferred.
- Minimum 10 years experience in clinical operations, including management of global clinical studies across Phases 2-3 and post-marketing.
- Track record of success in both large pharma and small biotech settings, including leading teams and studies through periods of strategic growth and change.
- Deep understanding of ICH-GCP, regional/global regulatory frameworks, and clinical trial governance standards.
- Experience with both company-sponsored and externally-sponsored studies involving development and commercial partners.
- Proven ability to foster a collaborative, accountable, and high-performance team culture.
- Comfortable working in fast-paced, dynamic settings with a strong hands-on leadership style.
- Analytical, data-driven, and solutions-oriented with strong communication and influencing skills.
- Strategic operational leadership
- Clinical trial execut