VP / ED, Head of Clinical Operations

RESPONSIBILITIES IN A NUTSHELL:

• Manage an in-house team of 20+ as well as oversight of CROs and other vendors. Provide sound leadership to ensure an effective and cohesive team by focusing on team and individual performance, mentorship, coaching, and career development activities. Establish the departmental goals in support of the Company’s corporate objectives and ensure that your direct and indirect reports each have aligned goals
• Be responsible and accountable for managing the clinical operations and study budgets, including budget preparation, forecasting, tracking and variance reporting.
• Lead the operational oversight of company-sponsored clinical trials ensuring that they are completed on time and within the approved budget
• Participate in the preparation of clinical study documents, including Protocols and Amendments, Study Reference Manuals, CRF design, ICFs, CSRs, and IBs.
• Assist in preparing clinical module documents for IND, NDA, and MAA submissions.
• Participate in the selection, review, and approval of clinical sites and investigators.
• Plan and lead Investigator Meetings.
• Working with the CMC team and applicable vendors, work to forecast investigational product supply needs and oversee the supply chain with the CMC team.
• Conduct regular resource planning reviews to ensure that clinical development projects are adequately resourced in time and that the team is properly staffed to support clinical development programs
• Lead regular cross-functional team meetings.
• Interact regularly with executive management including presenting to BoD.
• Work with the Medical Monitors, Regulatory Affairs, and the Drug Safety and Pharmacovigilance (DSPV) vendor to ensure that the Company’s drug safety and pharmacovigilance obligations are in compliance with US and global regulatory authority safety reporting obligations.
• Ensure that clinical trials are conducted and monitored in accordance with GCP/ICH guidelines and Company SOPs. Work with the GCP vendor on the development of new, and periodic revisions of existing, clinical SOPs.

DESIRED SKILLS / QUALIFICATIONS / EXPERIENCE:

• • BA/BS or higher
  • 12+ years of experience in pharma/biotech/CRO
  • US pivotal trial experience is required. EU / Canada experience is a plus.
  • Prior NDA/BLA/MAA submission experience is a plus.
  • Experience with pre-approval FDA or EMA inspections would be a plus.
  • Prior people management experience as you will be leading a 20+ person team of Project Managers, In-House CRAs, and Field-based CRAs. Demonstrated history of performance managing, mentoring, and building teams.
  • Prior experience leading a Clin Ops department or leading a Clinical Ops therapeutic area, or leading a major global clinical program through a global pivotal trial is ideal
  • Experience with complex therapeutics (such as respiratory drug/device, acute care, anti-infectives, rare disease) is a plus
  • Experience developing SOPs and clin ops metrics is desired
  • A varied background with time spent in Clinical Research, Regulatory, Quality, etc. would be a plus but is not required
  • Desire and ability to work in a fast-paced environment with more visibility than in “Big Pharma”
  • Seeking a self-driven, highly organized, detail-oriented, self-aware, accountable, collaborative, independent, high-EQ individual
  • Demonstrated experience of making a meaningful impact (i.e., “but for” your efforts, the same successful result may not have been achieved)