Associate Director, Clinical Trial Operations

Insmed Gene Therapy • San Diego, CA

2d • Remote

About The Position

We’re looking for an Associate Director, Clinical Trial Operation on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Clinical Operations – Gene Therapy, you’ll be responsible for the overall leadership, management, and oversight of phase I-IV clinical trials from protocol concept through Clinical Study Report (CSR) to ensure all study(s) are delivered on time, within budget, and with high quality data. You will also lead the cross- functional Clinical Study Team (CST), CTMs, CTAs, the Contract Research Organization (CRO) and other vendors (as applicable) to ensure execution of all operational aspects of clinical study(s) planning, implementation, data delivery and reporting. You will also drive the adoption and integration of digital health and eClinical technologies to enhance data quality, operational efficiency, and real-time trial oversight, as well as champion patient-centric trial design as a core leadership expectation, ensuring that study execution strategies prioritize patient experience, accessibility, and engagement throughout the clinical development lifecycle.

Requirements

• Bachelor’s degree in the life sciences, healthcare, or related field
• 7+ years in trial management with a sponsor company managing various phase clinical trials
• Experience in global clinical trial conduct in multiple phases of development across several therapeutic areas
• Experience in financial management of clinical trials, including budgeting, forecasting, accruals, invoicing, etc.
• Experience in CRO, vendor and laboratory selection, set-up, and management
• Excellent communication skills (verbal and written)
• Possess critical thinking skills for problem solving, conflict resolution, collaboration, interpretation and in leadership tasks
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies

Nice To Haves

• Experience in rare disease and/or orphan indications is preferred
• Experience in the management across a development program and participation in NDA/sNDA filing is preferred

Responsibilities

• Provide leadership and management of a clinical study(s) and clinical operations aspects of a drug development program in compliance with ICH GCP guidelines and relevant regulatory guidelines.
• Establish and lead the clinical study team and CST meetings throughout the trial – overseeing team member maintenance of trial-specific training and facilitating continuity during team member transitions
• Manage and oversee the operational aspects of Insmed’s clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, clinical trial sites, etc
• Review metrics and Key Performance Indicators to identify trends and trigger proactive risk management activities where applicable and ensure oversight of clinical trial progress
• Oversee the day to day of clinical trial execution
• Create and/or review and approve specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, study plans
• Apply Risk-Based Quality Management (RBQM) principles to ensure data integrity and patient safety
• Lead vendor (including CRO) selection process in collaboration with vendor alliance and procurement colleagues (as applicable) and other key internal stakeholders and provide input to the request for proposal process (if applicable) contract/work order reviews, and maintenance through trial closeout
• Oversee vendors' adherence to contractual obligations including proactively recognizing changes in scope (eg cost, timelines)
• Cross-check quality and completeness of study documents and reconciliation with eTMF colleagues and other functional areas throughout the trial lifecycle
• Provides mentorship to assigned study staff (CTMs, and CTAs) or colleagues as assigned by the Senior Director

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement
• Access to our Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups
• Service and recognition programs
• Meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Director