Director, Clinical Operations
BPGbio · Waltham, Massachusetts, US
NO AGENCIES - PLEASE! Please note: This position requires the individual to be on-site (no remote work). Relocation assistance is not provided.
Job description
NO AGENCIES - PLEASE!: Please note: This position requires the individual to be on-site (no remote work). Relocation assistance is not provided. POSITION SUMMARY: The Director of Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed-upon timelines and budgets. This role reflects the knowledge, experience, skill levels, and capacity to manage complex studies or programs. ESSENTIAL DUTIES AND RESPONSIBILITIES: Strategic Planning: - Develop and execute strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives. - Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans. Clinical Trial Management: - Oversee the design, planning, and execution of clinical trials, including Phase I-III studies, ensuring adherence to timelines, budgets, and quality standards. - Lead the selection and management of Contract Research Organizations (CROs) and vendors involved in clinical trials. - Monitor clinical trial progress and identify and mitigate risks and issues tha...