Director, Clinical Operations

Must be willing to be in-house in Boston (Prudential Center, Boylston Street, four days per week)

• Provide leadership and manage end-to-end processes involved in outsourced clinical trials, key deliverables are:
  • Maintaining and remediation of operational efficiency at RT and designated CRO demonstrated by meeting development program goals per plan and within agreed upon budget
  • Influencing, advising on, and analyzing study conduct issues and creating optimized and documented systems for study conduct at sponsor, CRO, and research site levels
  • Direct site interaction managing site-specific subject identification, data entry oversight from a Clin Ops perspective, point of escalation for reimbursement issues
  • Final responsibility for research site contract and budget negotiations
• Subject Matter Expert (SME)on ICH E6 rev 3
  • Exercising consistent judgment and discretion within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for GCP-compliant and phase-appropriate study conduct
• Functional lead and responsible for GCP compliance and remediation in conjunction with the Head of QA
• Core member of infrastructure development team
  • Clinical business lead for infrastructure evaluation and implementation
• Core NDA preparation team member
  • Key planning role
  • Reviewing and authoring assigned sections
  • Coordinate timing and quality of deliverables from ESPs

Candidate Profile

• BS minimum degree requirement, MS or MA is preferred; an RN, BSN, FNP, PA experience is a plus
• Internally motivated to deliver high-quality work products on time and within budget
• Excellent communication and planning skills
• 10+ years of clinical trial operations experience and experience working in a smaller, fast paced environment highly preferred.
• Practical and broad experience with key elements of clinical trial management including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner
• Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for site activation and monitoring, data handling, medical writing, and safety reporting
• Experience building an internal clinical operations management function as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed
• Experience running and overseeing internationally conducted studies in rare-disease indications
• Experience with regulatory submissions, especially including INDs, annual reports for INDs, ODD, and FTD
• Able to prioritize multi-faceted role against dynamic timelines and rapidly changing corporate needs
• Advanced working knowledge of Microsoft Excel, PowerPoint, and Project
• Bonus: working experience using SmartSheets®, One-Pager Pro™, Medrio and Oracle clinical databases