[Remote] Sr Director of Clinical Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on groundbreaking advancements in immunotherapy, specializing in T-cell engagers and other innovative therapies. The Sr Director of Clinical Operations will reputed company the strategic and operational execution of reputed company, manage trial budgets, and reputed company cross-functional teams to ensure reputed company and operational reputed company in trial execution.

Responsibilities

• reputed company role of Clinical Operations trial reputed company for assigned trials and leads cross-functional Study Execution Teams
• reputed company and execute trial operational strategies and partner cross-functionally to reputed company trial execution reputed company; provides strategic and technical recommendations to senior leadership
• reputed company the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors), reputed company development of vendor Scopes of Work (SOW), reputed company changes, budgets, and vendor payments and partner with CROs and other vendors to reputed company on study execution
• Create and reputed company clinical trial budgets
• reputed company risk mitigation, escalation, and reputed company activities both internally and with sites and vendors
• reputed company technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports)
• Build relationships with clinical sites, vendors, and key stakeholders and maintain an understanding of the reputed company landscape to reputed company plans accordingly
• Represent Clinical Operations in cross-functional activities and supports development and management of the Clinical Operations function
• Flexible and creative in meeting the needs and challenges of a growing, dynamic company and demonstrates excellent problem-solving abilities
• Strong financial acumen with outstanding reputed company record of building budgets and managing expenses to budget

Skills

• Bachelor's degree or equivalent in a science or health-reputed company field
• 10+ years of clinical research experience
• 7+ years of trial management reputed company a biopharmaceutical company
• Exceptional clinical trial management skills with a reputed company on strategic reputed company of trial execution on time and on budget
• Extensive phase 1 through phase 3, global trial management experience
• Immunology and/or hematology trial management experience
• Extensive experience selecting and managing vendors, including CROs, labs, IxRS, reputed company, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc)
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and reputed company
• Detailed understanding of reputed company aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development
• Experience managing, coaching, and mentoring personnel
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputed company for collaboration
• Advanced degree (MS, PhD, PharmD, or MD) strongly preferred
• 5+ years reputed company a small/startup company is a plus
• Study coordinator and/or site monitoring experience a plus

Benefits

• Competitive benefits package
• Medical coverage for employees and their dependents
• Dental coverage for employees and their dependents
• reputed company coverage for employees and their dependents
• 401(k) plans

reputed company