Sr. Director, Head of Clinical Monitoring and Operational Systems

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What You’ll Do: Reporting to the VP of Clinical Operations, the Sr. Director of Clinical Monitoring and Operational Systems plays an integral role in the strategic development, oversight, and execution of global clinical monitoring and operational systems across MapLight’s entire clinical trial portfolio.  This role will develop forward‑thinking approaches to strengthen site relationships, guide the oversight of monitoring activities, and reinforce the organization's standing as a dependable and collaborative study sponsor.  Close collaboration with key cross-functional internal stakeholders, Clinical Operations, Clinical Development, Data Management and Clinical Compliance and Quality as well as external CRO and vendor partners is essential to ensure quality of monitoring conduct and oversight from study start up through close out. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment. Applicants should be outstanding team members with the ability to effectively lead a team and to communicate with and influence both internal and external stakeholders with a passion for positive site relationships and clinical participant experiences.

Responsibilities:

• Ensure global clinical monitoring is executed with high standards of quality and consistency while maintaining compliance with GCP regulations whether monitoring done by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs).
• Oversee Lead CRAs, providing support and guidance for their management of monitoring teams; creates a culture of continuous learning for all levels of clinical monitoring team members.
  • Conducts oversight monitoring visits and/or co-monitoring visits where required
• Enhance the framework for clinical site monitoring and site management strategies and activities. Partners closely with Trial Managers and Data Management leaders in aligning these strategies
• Oversee the Clinical Operations Systems team to support the continued development, efficiency and integrity of the eTMF and CTMS systems and team members.  
• Accountable to strengthen the monitoring, site management and clinical systems quality oversight strategy, with the development and maintenance of SOPs, processes, tools and templates. Partner closely with QA to maintain a compliance framework.
• Develop standardized key performance indicators (KPIs) and key quality indicators (KQIs) for implementation with monitoring plans, eTMF inspection readiness, and processes. Lead where appropriate, and participate and support internal audit and regulatory inspection activities related to site monitoring and sponsor oversight
• Grow and develop team members in the clinical monitoring and operations systems team. Assist in the development of career pathways and standardized functional training.
• Represents the monitoring and clinical operations system functions in senior management meetings, where applicable. Supports the LCRAs, in partnering with Clinical Leads and Trial Managers to ensure appropriate monitor resourcing for clinical studies.

Qualifications:

• Bachelor’s degree in a relevant field; a minimum of 12 years in the clinical trial industry with at least 5 years experience onsite clinical monitoring
• A minimum of 5 years providing global trial monitoring oversight with direct management of monitors.
• Experience managing FSP/CRO monitoring teams and developing monitoring quality metrics, KPIs, with demonstrated focus on building processes, standardization and efficiencies.
• Demonstrated experience with a variety of CTMS and eTMF platforms
• Demonstrated ability to be versatile, serve as a role model to more junior clinical staff and a willingness to teach others as evidenced by a collaborative work style.
• Competency in technical systems that improve efficiencies (ex. Power BI).
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• Deep working knowledge of ICH‑GCP, FDA, EMA, and other global regulatory requirements, and clinical operational standards.
• Demonstrated ability to attend to detail, make effective presentations and work independently.
• Ability to travel independently by air, car and/or train.

Travel:  Position may require up to 3