Director, Clinical Operations Program Excellence

The Director, Clinical Operations Program Excellence is responsible for enabling robust processes to ensure performance, compliance, and inspection readiness across Neumora Clinical Trials. This role is crucial to ensuring that clinical trials and operations are conducted in compliance with regulatory requirements and industry standards. This position involves proactive preparation and coordination of activities to ensure the organization is always inspection ready. The role will partner closely with the Neumora Quality Organization to effectively operationalize the required procedures for the Neumora Quality Management System to ensure it is routinely embedded in clinical development process. Oversight of vendor performance is a key component to ensuring quality, and a core deliverable of the role. This position requires scientific and operational expertise, in-depth knowledge of regulatory requirements, business acumen, and exceptional communication skills.

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.

Qualifications:
•    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)
•    Travel may be required but is not expected to exceed 25%

2024 Company benefits include:

• 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

The salary range posted describes the minimum to maximum base salary range for this position in the location listed.  Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $216,800-$230,047