Clinical Operations Development Lead

Responsibilities

• Oversee clinical activities within specific therapeutic indications or across assets
• Collaborate with MDL to create and execute the Clinical Development Plan (CDP)
• Lead the Clinical Development Team meetings and ensure strategic content focus
• Identify risks and issues, ensuring timely mitigation is reflected in risk registries
• Ensure consistency in trial setup and execution across various trials for the indication

Qualifications

• Bachelor's degree in a medical or para-medical field; PhD is a plus
• Minimum of 10 years in Clinical Development with leadership experience
• Experience with overseeing CROs and vendors in an outsourced model
• Background in rare diseases and/or autoimmune clinical trials is a plus
• Thorough knowledge of ICH GCP guidelines and regulatory requirements

Benefits

• Comprehensive health benefits package
• Retirement savings plans
• Participation in short-term and long-term incentive programs

Pay

• $212,000 – $291,500 annually

Schedule

• Remote - US based candidates only, no visa sponsorship available