Director/Senior Director, Clinical Operations - Redwood City, United States - Lassen Therapeutics

Description

Director-Sr. Director Clinical Operations

Lassen Therapeutics is a therapeutic antibody discovery and development company dedicated to the identification of novel medicines for serious unmet medical needs. 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.
• Able to work independently while exercising judgement, escalating issues in a timely manner, providing transparent assessment of study status and deliverables.
• Comfortable working in a fast-paced, dynamic, constantly evolving environment.

Lassen Therapeutics offers a competitive benefits package including medical, dental, vision and life insurance benefits for employees and their families. We also offer a 401(k) plan with a matching contribution, stock equity, unlimited time off and more.

This position will be primarily based onsite from our administrative offices in Redwood City, CA, with travel for job-related activities as required (expected travel for this position is <20%).

Lassen is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected category.