Clinical Operation Director

We are seeking a highly experienced and motivated Clinical Operations Director to join our team in Taipei. The successful candidate will lead the planning, development, and execution of clinical operations, ensuring study protocols are well-designed and compliant with Good Clinical Practice (GCP) and all relevant regulations and standards. The role includes managing daily clinical study operations, including oversight of CROs, site initiation, patient enrollment, data collection, and KOL/PI management. The Director will also handle data analysis and presentation of results to key stakeholders.

Responsibilities:

• Develop and implement clinical operations strategies aligned with company objectives and regulatory requirements.
• Lead clinical trials from the design phase through to completion.
• Provide strategic leadership, manage timelines and budgets, and oversee progress in clinical trials, ensuring timely decision-making.
• Collaborate with external partners on out-licensing of clinical assets and develop contingency plans to mitigate risks.
• Ensure continuous process improvement and compliance with regulatory standards and internal policies.
• Communicate effectively with internal and external stakeholders, including senior management, regulatory agencies, and clinical teams, to provide updates on study progress, challenges, and milestones.

Requirements:

• Preferred: Ph.D. in Life Sciences, Pharmaceutical Sciences, Clinical Research, or a related field.
• Experience: Minimum of 10 years in clinical operations within the pharmaceutical or healthcare industry. Experience across all phases of clinical studies (Phases 1, 2, and 3) and a deep understanding of their strategic value.
• Proven experience working with regulatory authorities (e.g., US FDA, EMA) and the ability to develop clinical development strategies.
• Demonstrated experience in large, matrixed organizations with cross-functional collaboration.
• Proven track record of managing and collaborating with CROs, particularly in the USA, with strong negotiation and communication skills.
• Strong knowledge of clinical trial methodology, GCP, and regulatory requirements (FDA, EMA, ICH guidelines).
• Excellent leadership, organizational, strategic thinking, analytical, and problem-solving skills.