Carmot Therapeutics, Inc. is a clinical stage biotechnology company dedicated to delivering life-changing therapeutics for people with metabolic diseases. To support this vision, we are looking for an experienced and highly motivated Associate Director to work closely with the rest of the Clinical and cross-functional team members to ensure successful execution of clinical trials. The Associate Director, Clinical Operations will be accountable for the day-to-day operational oversight of one or more clinical trials in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This position reports to the VP, Clinical Operations.

　　Essential Functions:

　　Manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team

　　Manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards

　　Ensure the progress and completion of projects according to timelines

　　Prepare and present project specific updates

　　Lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports

　　Monitor safety surveillance and reporting activities

　　Oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation

　　Coordinate DSMB/safety reviews in line with charter and overall study parameters

　　Assist in the construction of Clinical Operations processes and procedures, including development and writing of SOPs, creation and organization of study Trial Master Files, and clarification of organization and workflow structures

　　Plan, generate, and track study timelines and trial budgets

　　Site management activities, including: review monitoring reports, interact with study monitors, track deviations or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as Carmot contact, as needed, for clinical sites

　　Other duties as assigned

　　Education:

　　BA/BS degree in scientific field or nursing required, MS or MBA a plus

　　Advanced degree preferred

　　Equivalent experience may be accepted

　　Experience:

　　6+ years of clinical research in the biotechnology/pharmaceutical industry

　　4+ years of multi-center clinical trial management experience, specifically experience in Phase 2 and Phase 3 US and international clinical trials

　　Experience managing CROs, central laboratories, and other clinical study vendors

　　Experience preparing clinical trial protocols, budgets, and contracts

　　Experience in metabolic drug development is desirable

　　Computer Skills:

　　Proficiency with MS Word, Excel, and PowerPoint is required

　　Proficiency with MS Project is preferred

　　Bonus Skills:

　　Strong leadership and management skills

　　Excellent teamwork and collaboration skills

　　Outstanding written and verbal communication skills

　　Independent, innovative, and creative thinker

　　Expert knowledge of scientific principles and concepts

　　Ability to interpret and evaluate clinical data

　　High level organization and time management skills

　　Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands

　　Travel Requirements: Low, < 15% (domestic and international)

　　Direct Reports: None

　　Work Style: Hybrid. Must be located in the San Francisco, Bay Area

　　Must be authorized to work for any employer in the U.S.

　　Carmot offers competitive compensation, and a comprehensive health & wellness package that includes the following:

　　Choice of medical insurance plans which includes PPOs and HMOs

　　Dental and vision insurance

　　Life, short- and long-term disability

　　Lifestyle spending account

　　Peer recognition program

　　401(k) Retirement Plan with Company Contribution

　　Separate paid vacation and sick time plans

　　Wellness days

　　Maven Clinic, which offers support and family-forming benefits for employees on any path to parenthood, plus paediatric, menopause support, and more

　　Spring Health, a full-service mental health platform that pinpoints and delivers the right level of care for each employee and their dependants, including digital support, meditation, coaching, therapy, medication and beyond

　　Year-end winter shutdown

　　Carmot Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.