In this vital role as Associate Director, Clinical Operations you will be the lead point of contact for the operational strategy, planning, risk assessment and mitigation, and overall delivery of assigned clinical trials within the navacaprant program. This role will report to the Senior Director, Clinical Operations, and collaborate daily with members of Clinical Development, Regulatory, Data Management, Biostats, Pharmacovigilance, Clinical Supply, Clinical Quality and others to align on strategy and execute organizational deliverables/goals in the most compliant, efficient, high quality, and timely manner. Additionally, you will support continuous process improvement initiatives within Clinical Operations.

Responsibilities:

• Manage team of clinical trial managers and/or oversee clinical trial consultants
• For full-time clinical trial managers, lead all aspects of people management, career development, performance and just-in-time feedback, training and succession planning
• Support the Senior Director with the following activities:
• Develop operational strategy, plans, risk assessment and mitigation, and deliver outcomes of assigned clinical trials within the navacaprant program
• Deliver high-quality clinical trials on time and within budget
• Provide clinical operations leadership and expertise on the CRO/company teams as well as internal governance teams
• Provide clinical operations leadership, expertise, and oversight of the end-to-end study delivery from vendor identification/selection and feasibility through to study outcomes and closeout
• Support protocol, informed consent and study, including vendor, document development
• Engage in timelines and scenario planning
• Manage study budgets including negotiations, change orders, and invoice approval
• Support and potentially lead the program and study-specific risk assessment process in collaboration with the cross-functional team
• Collaborate with clinical trial managers in the management of study-specific operational/vendor issues and CAPAs, ensuring that cross-functional input and awareness is considered when appropriate
• Collaborate with and manage relationships cross-functionally and with key vendors/business partners
• Effectively lead sub/team meetings and/or meetings to address emergent issues to resolution while maintaining operational consistency and standards across the clinical studies
• Effectively and proactively communicate updates, risks, challenges, mitigations, and resolutions to the Senior Director and/or cross-functional team
• Support the development and execution of clinical trial data management plans and timelines
• Review clinical trial data for quality and trends, and assess vendor performance against KPIs o Ensure the TMF is continually inspection ready
• o Participate in resolution of site and vendor audit responses, as well as inspection readiness planning and execution
• o Facilitate sharing of best practices and look for opportunities to improve processes
• Effectively and proactively collaborate and align with the Senior Director on all of the above

Qualifications:

• BA/BS degree or higher, preferably in life sciences with 8+ years of relevant experience
• 2 years of monitoring experience preferred
• End-to-end experience managing/overseeing Phase 3 clinical trials from feasibility through study readout and closeout; CNS trial management experience preferred
• Experience managing vendors
• Experience managing fully outsourced studies preferred
• Experience managing direct reports
• Experience at large and small pharma preferred
• Understands the importance of timely communication/escalation of updates and issues
• Anticipates and proactively identifies mitigations; thinks outside the box to find creative solutions to issues
• Excellent attention to detail, follow through, oral and written communication skills; can effectively synthesize and translate information to internal and external stakeholders in order to drive decisions and results
• Has the confidence to engage and communicate with various levels of senior leadership
• Can thrive in an environment that is fast paced, presents daily challenges, is occasionally ambiguous, and encourages positive change
• Can identify gaps and is willing to take the initiative to address those gaps as necessary
• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements
• Computer literate with well-developed skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, Visio, and Outlook)
• Prior experience with eTMF, CTMS and EDC systems preferred
• 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: $185,500-$198,671