Director, Clinical Science

Job Title: Director, Clinical Science Department: Clinical Location: Boston, MA / Hybrid Employment Type: Full-Time --- A biotech company operating in stealth mode in the neuropsychiatry space is seeking an experienced Clinical Trial Management professional to provide expertise in the development, execution and operations of clinical trials across all phases of development. Position Summary The Senior Manager/Associate Director, Clinical Operations, will support clinical operational oversight in alignment with corporate goals. This role will be responsible for ensuring the successful execution of clinical trials to meet program timelines, budgets and quality expectations in full compliance with regulatory requirements (FDA, GCP, ICH and other applicable regulatory guidelines). Working on-site in Boston is expected 2-3 days per week. Duties and Responsibilities • Execute clinical development programs aligning with corporate timelines and budget goals and ensuring operational excellence. • Support the development of SOPs for clinical trial conduct, safety oversight, regulatory submission activities and across all clinically related functional areas. • Closely collaborate with functional areas with a focus on supporting highly integrated cross functional project teams for programs and trials. • Supervise all aspects of clinical trial execution across multiple programs and studies including contribution to study design and implementation of clinical protocols, operational plan development, clinical data collection, risk mitigation and quality management. • Ensure site monitoring and participant safety oversight is conducted in accordance with study monitoring plans, safety management plans and regulatory requirements • Support regulatory applications including US IND and NDA applications, ex-US CTAs or other global applications and participate in internal or external study related audits. • Identify, evaluate and recommend the selection of third-party vendors, consultants, sites and CROs based on capabilities, expertise, quality of service, ability to hit aggressive timelines and cost efficiency. • Oversee and foster CROs and third-party vendor relationships and serve as a representative on governances as required. Required Qualifications • At least 5+ years of experience in clinical operations within a healthcare or clinical research environment. • Bachelor's degree or equivalent experience in a scientific or health-related field is required. • Experience in psychiatric CNS disorders and global Phase 2 and 3 trials is preferred. • Strong knowledge of regulatory requirements, GCP's, FDA regulations and ICH guidelines and clinical compliance standards. • Exceptional project management skills with a track record of efficient execution of clinical trials. • Proven ability to prioritize tasks and work on multiple projects in a fast-paced environment. • Strong writing, communication, presentation and interpersonal skills with the ability to interact effectively with all levels of management both within and outside the organization. Please submit resume to View email address on click.appcast.io