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.