Associate Director, Clinical Operations

Role Summary

Associate Director, Clinical Operations, reporting to the Director, Clinical Operations, will ensure excellence in clinical trial planning, execution, and data collection in accordance with regulatory guidelines. This role will lead a Phase 2 registrational clinical study with responsibilities including inspection readiness, contract negotiation, budget management, study conduct, and close-out. The position requires collaborative oversight of a cross-functional study team and effective management of and partnership with CROs and vendors. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharmaceutical company and delivering high-quality clinical trial results.

Responsibilities

• Lead and manage and provide strategic input on one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management. Lead cross-functional clinical study team to support clinical study delivery.
• Evaluates, selects, and ensures appropriate oversight of CROs and other external vendors.
• Ensures clinical trials are executed according to scope of work, budget, timelines, and KPIs
• Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support corporate goals.
• Identify risks and propose solutions to facilitate clinical studies.
• Develop and demonstrates accountability for the management of study budgets through review and approval of contracts and/or work order changes; manages budget forecasting and accruals in collaboration with finance.
• Oversee and manage the creation, maintenance, QC and close out of TMF activities.
• Ensure appropriate oversight of enrollment, site activation and data collection milestones.
• Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
• Collaborate with the Clinical Data Manager to ensure timely and efficient database lock
• Participate in data review and reconciliation efforts.
• Mentor junior team members by delegating study related responsibilities, overseeing, and supporting development plans.
• Lead or co-lead department initiatives to support an expanding organization.
• Travel may be required (10% – 15%).

Skills

• Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning.
• Excellent problem solving, communication and organization skills.
• Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
• Ability to work in a collaborative environment and build effective working relationships across the organization. Able to thrive in a remote/virtual environment.
• Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously.

Qualifications

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with relevant experience in the biotech, pharmaceutical, or CRO industry.
• Minimum of 8 years of Clinical Operations experience.
• Extensive knowledge of ICH-GCP guidelines.
• Leadership experience in regulatory inspections preferred.
• Experience managing early through late Phase global oncology clinical trials
• Demonstrated cross-functional leadership fostering team spirit and team motivation.
• Capability to challenge status-quo using risk management approach.

Education

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with relevant experience in the biotech, pharmaceutical, or CRO industry.