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Director/Sr. Director Clinical Operations

We are currently recruiting an experienced and highly motivated Director/Sr. Director, Clinical Operations to join us and provide hands-on management to support clinical trial planning and execution of our Phase 1/2 clinical trials.  In this role, you will have a unique opportunity to help build our therapeutic pipeline of novel antibody-based medicines with applications in tissue fibrosis, inflammation and oncology.

Responsibilities:

  • Develop and implement strategic plans for Clinical Operations to support organizational goals and deliverables.
  • Provide oversight of clinical research organizations (CROs) and vendors to ensure timely and quality deliverables.
  • Establish and analyze KPIs to assess progress, identify risks, and manage issues that could impact the conduct of clinical trials.
  • Oversee the clinical aspects of data collection, development of cross-functional timelines for data deliverables, and management of sites and vendors to ensure availability of top-line results.
  • Contribute to and/or lead development of core study documents (protocols, ICFs, IBs, SAPs, CSRs).
  • Facilitate operational and therapeutic area training for study team members and oversee effective training of clinical sites and clinical monitors.
  • Manage clinical trial budget, resources, and timelines to ensure efficient and cost-effective execution. Review study invoices and study accruals to track financial status of the study against the budget.
  • Support establishment of Clinical Operations SOPs, Work Instructions, templates, standards, and best practices.
  • Manage direct report(s) and mentor Clinical Operations team members.
  • Provide regular study updates to leadership and contribute to strategic initiatives to advance clinical programs.
  • Assist in development of program-level timelines, budgets, and resource planning

Requirements:

  • Bachelor’s degree with a preferred focus on a life science or healthcare related field.
  • 12+ years of experience working with CROs. Rare disease experience is a plus.
  • 5+ years of experience managing direct reports, evidence of strong leadership, team-building, and hands-on management.
  • Experience developing and managing study timelines. Microsoft Project experience preferred.
  • Comprehensive knowledge of ICH GCP regulations, as well as applicable regulations.
  • Excellent communication skills with external vendors/CROs, cross-functional teams, and several different levels of the company including senior management.

Lassen Therapeutics is an EEO employer, and offers a competitive salary and benefits package.

Apply

Please contact careers@lassentherapeutics.com to apply or for further details.