Associate Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Contribute to the strategic and operational planning for both short- and long-term therapeutic or functional areas.

• Provide leadership, direction, oversight, and therapeutic expertise in the execution of clinical trials.

• Oversee the strategic, operational, and financial aspects of assigned programs.

• Develop, implement, manage, and successfully complete clinical trials within allocated budgets and timelines.

• Establish the strategic direction for clinical trials and associated programs.

• Evaluate, onboard, and manage CROs and other vendors, including the RFP and selection processes.

• Participate in Clinical Development Programs as a member of the Clinical Sub-Team and possibly the Global Development Team.

• Lead cross-functional Study Management Teams and effectively influence stakeholders.

• Analyze project status and challenges, implementing risk mitigation strategies as necessary.

• Anticipate potential obstacles and devise solutions to meet project objectives.

• Address and adhere to national and international regulations, guidelines, and interactions with investigators.

• Communicate project status and challenges to relevant stakeholders.

• Monitor, oversee, and communicate program status using the available tools.

• Provide leadership input for study-related documentation, including protocols.

• Manage Clinical Operations activities at the affiliate level in compliance with local regulations or standard practices.

• Initiate, author, or assist in the development, implementation, and training of SOPs.

• Ensure team compliance with established practices, policies, processes, and regulatory requirements.

• Recruit, develop, and retain a diverse workforce; set expectations; coach direct reports and foster the development of future leaders.

⛳️ Requirements

• Bachelor's Degree with Ten Years' Experience OR Master's Degree with Eight Years' Experience OR PhD/PharmD with 2 Years' Experience.

• Prior experience in oncology clinical trials, specifically with a minimum of 3+ years in designing and delivering Phase 1 first-in-human (FIH) oncology clinical trials.

• Relevant clinical or related experience in the life sciences field.

• Typically requires a minimum of 6 years of cross-functional study management or related leadership experience within life sciences.

• Several years of experience in managing study management or project teams.

• Experience in developing RFPs and the selection and management of CROs or other vendors.

• Proven track record of managing clinical studies within specified program budgets and timelines.

• Expertise in authoring clinical study and regulatory documentation as well as SOPs.

🏝️ Benefits

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.