Associate Director, Clinical Operations

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

📋 Description

• Contribute to both strategic and operational plans for therapeutic or functional areas, focusing on short- and long-term goals.

• Provide leadership, direction, oversight, and therapeutic expertise for clinical trials.

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

• Develop, execute, manage, and finalize clinical trials within specified budgets and timelines.

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

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

• Play a role in the strategic execution of Clinical Development Programs as part of the Clinical Sub-Team and potentially the Global Development Team.

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

• Analyze project status and challenges while implementing risk mitigation strategies.

• Anticipate complex challenges and devise appropriate solutions.

• Navigate national and international regulations, guidelines, and interactions with investigators.

• Keep stakeholders updated on project status and any arising issues.

• Monitor, manage, and communicate program status utilizing available tools.

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

• Supervise Clinical Operations activities conducted by the affiliate to support clinical trials.

• Initiate, draft, or contribute to the development, implementation, and training of SOPs.

• Ensure team activities align with established practices, policies, processes, and regulatory standards.

• Recruit, develop, and retain diverse talent; establish expectations; and coach direct reports on performance, growth, and career aspirations.

⛳️ Requirements

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

• Previous experience in oncology clinical trials with a minimum of 3+ years in the design and execution of Phase 1 first-in-human (FIH) oncology clinical trials.

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

• Typically, at least 6 years of cross-functional study management or related leadership experience in life sciences.

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

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

• Capability to manage clinical studies within designated program budgets and timelines.

• Proficiency 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.