Clinical Operations Development Lead

Job Summary

Leading clinical development activities for specific therapeutic indications, the full-time Clinical Operations Development Lead will oversee clinical trial budgets, collaborate with cross-functional teams to create and execute Clinical Development Plans, and ensure compliance with regulatory standards in a remote work environment.

Key responsibilities

• Oversee clinical trial budgets and timelines, ensuring alignment with the Clinical Development Plan and regulatory requirements
• Co-lead the Clinical Development Team, facilitating meetings and driving the execution of clinical programs in collaboration with team members
• Identify and mitigate risks related to clinical trials, ensuring effective communication and resolution of issues within the team

Required qualifications

• Bachelor's degree in a medical or para-medical field; PhD is a plus
• Minimum of 10 years of experience in Clinical Development, including leadership roles in the pharmaceutical or biotech industry
• Experience managing outsourced models, including oversight of CROs and vendors
• Background in rare diseases and/or autoimmune clinical trials is advantageous
• Thorough knowledge of ICH GCP guidelines and applicable regulatory requirements