Associate Director, Clinical Operations

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

📋 Description

• Direct and guide teams comprised of both direct and indirect reports while overseeing talent development.

• Offer insights into strategic and operational plans within therapeutic and functional areas.

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

• Ensure strategic, operational, and financial management of assigned programs.

• Design, implement, manage, and successfully complete clinical trials within budgetary and timeline constraints.

• Establish a strategic vision for clinical trials and programs through collaborative efforts across functions.

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

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

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

• Assess project status and challenges, implementing strategies for risk mitigation.

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

• Communicate project statuses and issues to relevant stakeholders.

• Monitor, oversee, and report on program status.

• Provide leadership input for study documentation, including protocols.

• Oversee Clinical Operations activities at affiliates as required by local regulations or practices.

• Initiate, draft, contribute to, implement, and train on Standard Operating Procedures (SOPs).

• Ensure team adherence to practices, policies, processes, and regulatory standards.

• Foster inclusion, develop talent, and empower teams.

⛳️ Requirements

• Bachelor’s Degree with ten years of experience OR Master’s Degree with eight years of experience OR PhD/PharmD with two years of experience.

• At least six years of cross-functional study management or relevant leadership experience in life sciences (preferred).

• Proven experience in developing RFPs and selecting as well as managing CROs or other vendors.

• Several years of line management experience.

• Experience in managing clinical studies within established program budgets and timelines.

• Proficiency in authoring clinical study and regulatory documentation, including SOPs.

• Meet all requirements for the Clinical Program Manager (CPM) grade 29 position, demonstrating proficiency.

• Expert knowledge in one or more disease or therapeutic areas.

• Comprehensive understanding of the full-cycle study management, from initiation to closure.

• Advanced knowledge of best practices and tools in study management.

• In-depth knowledge of FDA, EMA, applicable national regulations, ICH guidelines, and GCP.

• Strong financial skills for managing clinical trial budgets.

• Excellent leadership, interpersonal, communication, organizational, negotiation, and conflict resolution abilities.

• Proven ability to lead without formal authority and influence programs, projects, and initiatives.

• Demonstrated success in hiring, managing, and developing diverse talent.

• Shown effectiveness in proactively managing change.

• Willingness to travel as necessary.

🏝️ 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.