Associate Director/ Director of Clinical Operations
Full-time
Director/C-Level
3 days ago
SCG Cell Therapy Pte Ltd is a clinical-stage biotechnology company with the focus on developing novel immunotherapies for patients with pathogenic inf..
SCG Cell Therapy Pte Ltd is a clinical-stage biotechnology company with the focus on developing novel immunotherapies for patients with pathogenic infections and its associated cancers.
At SCG Cell Therapy Pte Ltd, you will have the chance to develop your career and be part of the global team. We believe that creating opportunities for our people and developing people skills is crucial to our growth and success. If you are inspired to change the lives of patients using cutting edge technology all over the world, we’d love to hear from you.
About the role
The Associate Director/ Director of Clinical Operations is responsible and accountable for the strategy and delivery of SCG Cell Therapy’s Oncology programs and studies. You will ensure that all trials are performed in accordance with ICH/GCP and applicable regulations, within time and budget, and with quality. The ideal candidate will have a proven track record of success in managing complex global clinical trials and leading cross-functional teams.
Key Responsibilities:
- Accountable for the overall clinical operations strategy, and continuously refine the clinical operational strategy in response to the evolving landscape to ensure clinical trial delivery aligns with the Clinical Development Plan (CDP)
- Manage and monitor clinical trial budgets and timelines, ensuring efficient resource allocation and timely delivery of milestones
- Maintain active oversight of study delivery, monitor portfolio status, proactively identify risks, and implement mitigation strategies to ensure seamless execution of clinical trials.
- Lead the relevant-vendor selection process, oversee, and maintain strong relationships with key vendors, establish clear performance metrics and KPIs for each vendor to measure success and accountability
- Collaborate with cross-functional stakeholders to drive alignment
- People management and administrative oversight; develop a high-performing team, drive engagement, provide regular performance feedback, and manage administrative responsibilities related to team operations, to ensure effective team management
Who you are:
- 12+ years pharmaceutical clinical operations experience with at least 10 years being in global clinical operations especially for US and/or Europe
- Additional project management relevant experience is considered an asset
- Extensive experience in clinical operations, including a proven track record of leading complex clinical trials in Oncology from early-phase to late-phase development.
- Strong understanding of global regulatory requirements and clinical trial methodologies.
- Strong analytical and problem-solving skills.
- Excellent communication and presentation skills.
- Fluency in English with additional language skills as an asset
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