Director, Clinical Operations

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

📋 Description

• Serves as the Clinical Operations trial lead for designated trials and oversees cross-functional Study Execution Teams.

• Formulates and implements operational strategies for trials while collaborating across functions to advance trial execution; offers strategic and technical advice to senior management.

• Oversees the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors), manages the creation of vendor Scopes of Work (SOW), budget adjustments, and vendor payments while partnering with CROs and other vendors to ensure successful study execution.

• Develops and monitors clinical trial budgets.

• Manages risk mitigation, escalation, and resolution processes both internally and in collaboration with sites and vendors.

• Provides technical and strategic insights for the creation of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports).

• Establishes and nurtures relationships with clinical sites, vendors, and key stakeholders, remaining informed about the external environment and adapting plans as necessary.

• Represents Clinical Operations in interdisciplinary initiatives and aids in the development and management of the Clinical Operations function.

• Guides junior team members, including Clinical Trial Associates, through mentoring.

• Effectively cultivates strong internal teams and cross-departmental connections, showcasing leadership and team-building abilities, alongside a successful track record in proactive risk management and problem-solving.

• Adapts flexibly and creatively to meet the demands and challenges of a growing, dynamic organization while exhibiting excellent problem-solving skills.

• Possesses strong financial insights with a proven history of budget creation and expense management within budgetary constraints.

• Participates in corporate activities, including the preparation of materials for Executive Team and Board of Director meetings.

⛳️ Requirements

• Bachelor's degree plus 15 years of relevant experience, or a Master's degree plus 12 years of relevant experience.

• Over 10 years of clinical research experience, including more than 7 years in trial management within a biopharmaceutical company; experience in a small/startup environment is preferred.

• Exceptional skills in clinical trial management with an emphasis on strategic oversight of trial execution, ensuring timelines and budgets are met; experience as a study coordinator and/or site monitor is advantageous.

• Extensive experience managing global trials from phase 1 through phase 3.

• Experience in managing trials related to immunology and/or rare diseases.

• Significant expertise in selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g., eDiaries, eConsent, apps, etc.).

• Comprehensive knowledge of FDA and ICH Guidelines, GCP, medical terminology, and the clinical trial process.

• In-depth understanding of all elements of clinical protocol design, execution, IND/BLA/NDA submissions, and the overall drug development lifecycle.

• Proven experience in managing, coaching, and mentoring staff.

• Outstanding communication, organizational, negotiation, and interpersonal skills, with a strong reputation for fostering collaboration.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Paid time off

• Remote work opportunities