Neumora is hiring a
Director Clinical Operations Program Excellence

Summary

Join our team at Neumora as we revolutionize the way patients with brain disease are treated. We're seeking a Director, Clinical Operations Program Excellence to enable robust processes for performance, compliance, and inspection readiness across clinical trials.

Requirements

• 15+ years’ experience of clinical trial delivery, phase 1 through phase 3
• BA/BS degree or higher, preferably in life sciences
• Preferred experience of agency inspections
• Clear understanding of what it means to be inspection ready
• 10+ years of proven vendor management experience
• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements
• Excellent negotiation and contract management skills
• Exceptional communication skills and relationship-building skills
• Critical thinking skills with the ability to think strategically and drive results
• Self-motivated, proactive, and able to work independently as well as collaboratively
• Computer literate with well-developed skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, Visio, and Outlook)

Responsibilities

• Develop and implement strategies to ensure ongoing inspection readiness for clinical trials including the development of study and program storyboards
• Ensure Clinical Operations effectively partners to operationalize the required activities to maintain inspection readiness plans
• Oversee the creation, review, and maintenance of essential documents, ensuring accuracy and completeness
• Develop and implement document management processes within the TMF to facilitate efficient retrieval during inspections
• Stay informed about changes in regulations and industry standards and disseminate information to the team
• Ensure vendor compliance with contractual obligations and assist cross-functional teams with monitoring performance metrics
• Develop and maintain strong relationships with internal stakeholders and vendors, managing performance, promoting transparency, and fostering a culture of trust and collaboration
• Establish and maintain processes for ensuring vendor quality performance, including best practices (e.g., approach, processes, templates) for study teams conducting risk-based vendor oversight
• Establish and manage the vendor governance framework, chairing governance meetings
• Measure and communicate vendor performance (e.g., KPIs, cost, timelines), identifying areas for improvement, and implementing corrective measures, as needed
• Facilitate effective collaboration between internal stakeholders and vendors
• Ensure internal / external alignment on objectives, deliverables, timelines, and quality
• Facilitate resolution of issues that may arise between internal stakeholders and vendors
• Facilitate effective problem solving and conflict resolution to maintain healthy and productive partnerships

Benefits

• Medical, dental, vision, and life insurance
• 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• Company Equity (New Hire Awards, Annual Awards, ESPP)
• Annual paid time off
• Accrued Vacation Days: 15 days per year
• Sick Days: 10 days per year
• Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
• Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
• Discretionary year-end bonus