Associate Director, Clinical Trial Operations

Role Summary

We’re looking for an Associate Director, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Sr Director, Clinical Trial Operations, you’ll be responsible for the overall leadership, management, and oversight of phase I-IV clinical trials from protocol concept through CSR to ensure all study(s) are delivered on time, within budget, and with high quality data. You will lead the cross functional Clinical Study Team (CST), CRAs, CTAs, and the CRO to ensure execution of all operational aspects of clinical study(s) planning, implementation, data delivery and reporting.

Responsibilities

• Manage and oversee the operational aspects of Insmed‚Äôs clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, clinical trial sites, etc
• Lead CRO and other vendor selection and reviews contracts/work orders
• Provide mentorship to assigned study staff (CTMs, CRAs and CTAs) or colleagues as assigned by the Senior Director Reviews metrics and Key Performance Indicators to ensure oversight of clinical trial progress
• Participate in SOP and process development activities across Insmed functions
• Manage clinical study(s)/program budgets and execution study(s)/program timelines
• Oversee day-to-day of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and vendors
• Be responsible for the creation and execution of site and team training plans; plan and/or participate in investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings
• Participate in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials
• Present trial status and clinical operations strategy to project team and management
• Creates and/or reviews and approves specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, pharmacy manual
• Approve action plans to address protocol compliance, safety, data, and administrative issues with investigational sites and CROs
• Attend site visits to ensure oversight of CRO

Qualifications

• Required: Bachelor‚Äôs degree and 7+ years of experience in trial management with a sponsor company managing various phase clinical trials
• Required: Experience in global clinical trial conduct in multiple phases of development across several therapeutic areas
• Required: Experience in financial management of clinical trials, including budgeting, forecast, accruals, invoicing
• Required: Experience in CRO, vendor and laboratory selection, set-up, and management
• Required: Excellent communication skills (verbal and written)
• Required: Critical thinking, problem solving, collaboration, interpretation, and leadership abilities
• Required: Highly organized with strong attention to detail, clarity, accuracy, and conciseness
• Required: Demonstrated alignment with Insmed‚Äôs core competencies: Collaboration, Accountability, Passion, Respect, and Integrity

Nice To Have (but Not Required)

• Experience in rare disease and/or orphan indications
• Experience in managing across a development program and participation in NDA/sNDA filing

Additional Requirements

• This is a fully remote role with occasional travel for team meetings or events; travel up to 25% may be required