Sr. Director, Head of Clinical Monitoring and Operational Systems
The Sr. Director, Head of Clinical Monitoring and Operational Systems at MapLight Therapeutics is a pivotal leadership role within the Clinical Operations team. Reporting to the Vice President of Clinical Operations, this position is responsible for the strategic development, oversight, and execution of global clinical monitoring and operational systems across the company's clinical trial portfolio. MapLight Therapeutics is a clinical-stage biotech company dedicated to discovering and developing therapies for central nervous system disorders, utilizing advanced technologies to identify novel drug targets and address psychiatric symptoms.
Key responsibilities include ensuring that global clinical monitoring is conducted with high quality and consistency, in compliance with Good Clinical Practice (GCP) regulations. The role involves overseeing Lead Clinical Research Associates (CRAs), providing guidance and support to their management of monitoring teams, and fostering a culture of continuous learning. Additionally, the Sr. Director will enhance frameworks for clinical site monitoring, oversee the Clinical Operations Systems team to maintain the efficiency and integrity of electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS), and develop standardized key performance indicators (KPIs) and key quality indicators (KQIs) for monitoring plans and processes.
The ideal candidate will possess a bachelor's degree in a relevant field and have a minimum of 12 years of experience in the clinical trial industry, including at least 5 years of onsite clinical monitoring experience. A minimum of 5 years providing global trial monitoring oversight with direct management of monitors is required. Experience managing Functional Service Provider (FSP) or Clinical Research Organization (CRO) monitoring teams, developing monitoring quality metrics and KPIs, and demonstrated focus on building processes, standardization, and efficiencies are essential. Proficiency with various CTMS and eTMF platforms, competency in technical systems that improve efficiencies (e.g., Power BI), and a deep working knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements are also necessary.
Compensation for this role ranges from $270,000 to $300,000 annually, with additional benefits including an annual bonus opportunity, medical, dental, vision, life and AD&D insurance, short-term and long-term disability coverage, a 401(k) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
MapLight Therapeutics fosters a collaborative and dynamic work environment within a fast-paced and results-oriented setting. The company values team members who can effectively lead and communicate with both internal and external stakeholders, with a passion for positive site relationships and clinical participant experiences. This role offers significant growth opportunities within the organization, contributing to the advancement of therapies for central nervous system disorders.