Associate Director of Clinical Operations

Associate Director of Clinical Operations

Waltham, MA (On-Site)

Compensation: $190,000-$200,000

Company Summary:

This Biotech company is leading the development of transformative treatments for genetically driven neuromuscular diseases. Utilizing an innovative platform, the company is advancing targeted therapies for conditions such as myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD), and Pompe disease.

Primary Responsibilities:

• Manage all operational aspects of studies from start-up to close-out, ensuring adherence to timelines, budget, and milestones while complying with SOPs, guidelines, and regulations.
• Develop operational strategies and plans to support program objectives.
• Track invoices and budgets for individual studies and contribute to budget forecasting.
• Oversee the selection and management of CROs and vendors, monitoring their performance against contractual deliverables.
• Drive performance, quality, timelines, and relationships with CROs and vendors.
• Provide oversight of study scope, quality, timelines, and budget to ensure project objectives remain on track.
• Lead cross-functional teams and manage study teams in partnership with CROs.
• Engage with key opinion leaders and clinical site staff to support trial enrollment.

Qualifications:

• Bachelor's degree in a scientific or health-related field; an advanced scientific or business degree or equivalent experience is desirable.
• At least 8 years of experience in managing Phase I-III global clinical trials, ideally with both sponsor companies and CROs, ensuring quality, timelines, and budget expectations are met. Prior site and/or monitoring experience is a plus.
• Extensive experience in various complex therapeutic areas, with a preference for neuromuscular or muscle disease backgrounds. Experience with rare diseases and/or pediatric trials is also preferred.
• Strong understanding of the drug development process, ICH guidelines/GCP, and each step within the clinical trial process, including US/EU patient data privacy laws.
• Proficient in understanding clinical study budgets, accruals, and forecasting.
• Proven ability to lead teams in a fast-paced, matrixed environment, managing and prioritizing multiple tasks simultaneously.