Associate Director, Clinical Operations

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

📋 Description

• Manage and direct both internal and external clinical operations resources while actively participating in the strategy, tactics, and execution of global clinical studies at either a regional or global scale.

• Influence, oversee, and facilitate or lead the planning, budgeting, and study management processes associated with global clinical studies.

• Guide and collaborate with internal cross-functional teams to effectively manage external service providers, including CRO(s), vendors, and subcontractors responsible for executing global clinical trials, ensuring project deliverables are met on schedule and within budget at both regional and global levels.

• Assist in the formulation and operational design, planning, and strategic development of clinical trial protocols and study plans.

• Create or assist in scenario planning and risk-benefit analyses to provide recommendations aligning with corporate strategies.

• Contribute to performance excellence models by identifying best practices, evaluating measurement systems, and enhancing operational efficiency within the department.

• Review, evaluate, and manage resource strategies with both internal and external entities for global drug development programs while strategically collaborating with suppliers/CROs.

• Cultivate relationships with pharmaceutical partners and suppliers involved in clinical studies/programs to optimize delivery outcomes.

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

• May engage in Clinical submission activities.

• Lead or take part in clinical data reviews.

• Support the formulation and implementation of departmental Standard Operating Procedures (SOPs) for clinical trials and associated activities.

• Collaborate with various departments within and outside of Dianthus, including Finance, Regulatory Affairs, Legal Affairs, and Business Development.

• Represent the company at Investigator Meetings.

• Perform additional duties as assigned or determined.

⛳️ Requirements

• A minimum of an Undergraduate degree in Life Sciences (preferred), RN degree, or equivalent is required.

• Over 10 years of experience in the pharmaceutical or medical device industry as a clinical research professional, including a proven track record in project leadership and hands-on management of high-quality clinical trials from initiation to completion.

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

• Experience in direct line management or matrix team management, coupled with practical experience in monitoring and steering high-performing clinical trial project teams.

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

• Demonstrated capability to manage extensive and complex budgets.

• Familiarity with the drug development process, clinical development planning, and execution of clinical trials.

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

• Prior experience utilizing computer applications, including spreadsheets, email, word-processing software, and web-based systems (EDC, IVR/IWRS, CTMS).

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

• Capacity to offer creative yet practical solutions to challenges.

• Proficient in managing multiple projects concurrently while maintaining attention to detail; a high degree of creativity and autonomy is expected.

• Proactive in identifying potential issues and obstacles that could impede the effective implementation of trials and resolve them promptly.

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

• Collaborates effectively with team members.

• Willingness to travel (including internationally) and work across various cultures.

🏝️ Benefits

• Health insurance

• Professional development opportunities