Director, Clinical Operations

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November 17

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Precision Medicine Group

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Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

📋 Description

• Provide leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring) across countries • Ensure the delivery of high quality, timely and cost-effective clinical trial operations in compliance with ICH-GCP, Federal regulations, SOPs and other applicable regulations • Collaborate with executive management on the ongoing development of the Clinical Operations Department and contribute to the business plan at both the tactical and strategic levels • Develop and implement regional clinical operations strategies aligned with global business objectives • Serve as the regional expert for clinical development regulations and trial execution • Leads, manage, motivates and sets direction for operational staff • Ensure adherence to local regulatory requirements and oversee inspection readiness and support regulatory audits • Provide leadership and oversight on projects to ensure delivery according to timelines, budgets and quality metrics • Optimize the profitability of Clinical Operations Department to meet or exceed budget targets

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred. • A minimum 12 years of experience in clinical research, including extensive clinical and line management experience or proven competencies for this position • Expert knowledge of GCP/ICH guidelines and the clinical development process • Fluency in English and Mandarin is required. • Extensive experience of building and leading international teams in a global, cross-functional clinical management environment. • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc). • Excellent communication and interpersonal skills to effectively interface with others in a team setting. • Excellent organizational skills, attention to detail, and a customer service demeanour. • Experience in managing clinical aspects of complex and global trials. • Ability to travel domestically and internationally including overnight stays.

🏖️ Benefits

• Health insurance • Flexible working hours • Professional development opportunities