Associate Director, Clinical Operations

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

📋 Description

• Supervise and guide both internal and external clinical operations resources for worldwide clinical studies.

• Contribute to the strategy, tactics, planning, budgeting, study management, and execution of clinical trials.

• Serve as Clinical Project Manager responsible for the implementation, execution, and management of resources for studies.

• Ensure that clinical activities adhere to relevant regulations, ICH, and GCP guidelines.

• Oversee patient recruitment, select trial sites, optimize trial plans, and execute trials with a focus on quality.

• Manage CROs, vendors, subcontractors, suppliers, and pharmaceutical collaborators.

• Develop and operationally design clinical trial protocols, study plans, and development frameworks.

• Execute scenario planning and conduct risk-benefit analyses.

• Identify best practices to enhance operational efficiency.

• Ensure effective communication and information sharing across project and reporting functions.

• Participate in clinical submission activities and review clinical data.

• Support the development and implementation of department-level SOPs.

• Collaborate with Finance, Regulatory Affairs, Legal Affairs, and Business Development teams.

• Represent the company at Investigator Meetings.

⛳️ Requirements

• A minimum of an undergraduate degree (preferably in Life Sciences), RN degree, or equivalent qualification.

• Over 10 years of experience in the pharmaceutical or medical device industry as a clinical research professional.

• Proven project leadership experience and hands-on management experience in running high-quality clinical trials from initiation to completion.

• Strong knowledge of international regulatory standards and ICH GCP guidelines.

• Experience in direct line management or matrix team management.

• Practical experience in monitoring and managing high-functioning clinical trial project teams.

• Demonstrated success in coordinating external resources for clinical development and collaborating with pharmaceutical partners.

• Proven ability to manage large and complex budgets.

• Experience and understanding of the drug development process, clinical development planning, and execution of clinical trials.

• Knowledge of the clinical aspects of the therapeutic area and a willingness to develop in-depth expertise.

• Proficient in using spreadsheets, email, word-processing software, and web-based systems including EDC, IVR/IWRS, and CTMS.

• Ability to work independently as well as part of multiple integrated teams.

• Capacity to contribute innovative yet practical solutions to challenges.

• Ability to multitask and manage several projects simultaneously while maintaining attention to detail.

• Proactive in identifying and resolving issues and challenges impacting trial implementation.

• Highly effective verbal and written communication skills with both internal and external stakeholders.

• Ability to collaborate successfully with team members.

• Willingness to travel, including internationally, and work across diverse cultures.

🏝️ Benefits

• Option to work remotely.

• Opportunity to engage in potentially best-in-class therapies for severe autoimmune diseases.

• Chance to work with global clinical development programs and cross-functional teams.