Director, Clinical Quality Assurance
MapLight Therapeutics, a clinical-stage biotech company specializing in drug discovery for central nervous system disorders, is seeking an experienced and detail-oriented Director of Clinical Quality Assurance. This role involves leading the Clinical Quality team to ensure that clinical trials are conducted in compliance with quality guidelines and regulatory requirements. The Director will report to the Vice President of Quality and collaborate closely with organizational leadership to uphold quality standards across all clinical trials.
The Director will manage the Clinical Quality team and represent Quality Assurance at both internal and external clinical meetings. Key responsibilities include collaborating with Clinical Operations, Clinical Development, and Data Management teams to ensure that all processes contributing to the performance of clinical trials adhere to ICH guidelines and applicable regulatory requirements. The role also involves managing and maintaining clinical non-protocol quality events within the quality system, preparing quality management review reports, contributing to clinical quality improvement programs, evaluating quality events and complaints, and ensuring that investigator, vendor, facility, and system audits are conducted.
Candidates should possess a bachelor's degree in a scientific discipline such as Biology, Chemistry, Biochemistry, or Pharmacy. A minimum of 12 years of experience in Clinical Quality Assurance within the pharmaceutical industry is required. Applicants must have knowledge of applicable Good Clinical Practice (GCP) regulations and industry guidance, demonstrate the ability to assess risk and prioritize effectively, and possess strong organizational skills with exceptional attention to detail. The ability to work independently as well as part of a team is essential.
This hybrid position requires three days on-site at the company's office in Burlington, Massachusetts. The salary range for this role is between $210,000 and $230,000 USD annually. Additional compensation and benefits include 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 innovative work environment, focusing on cutting-edge technologies to develop effective therapies for psychiatric symptoms. Joining the team offers the opportunity to contribute to meaningful advancements in the field of central nervous system disorders within a dynamic and supportive company culture.