Senior Manager, Clinical Operations

Position Summary: The Senior Manager, Clinical Operations is responsible for scaling-up and managing the clinical trials team for DNAtrix's Phase 2 and 3 trials all the way through to filing, both domestically and internationally. This position reports to the VP of Clinical Operations and is located in San Diego, CA, or remote based depending on the geographic location of the candidate. Travel domestically/internationally (10-15%).

Specific Responsibilities: 

• Manages all aspects of DNAtrix’s  day-to-day clinical trial activities, CRO oversight (study/enrollment/protocols), and leads a clinical team of professionals to meet department and corporate goals/timelines
• Evaluates proposals/protocols, including budgetary requirements for clinical operations feasibility studies and conducts fair market value assessments. Presents outcomes to internal stakeholders
• Establishes partnerships with external/internal stakeholders to ensure efficient execution of the study management process. Identifies risks and develops strategies to achieve positive outcomes
• Ensures the integrity of clinical operations databases and repositories
• Contributes to the development and/or review of abstracts, presentations and manuscripts, protocols, writes reports and regulatory documents (e.g. IND, NDA, etc.)
• Informs and provides updates to key stakeholders regarding clinical trial deliverables/timelines. Identifies risks/gaps early on and provides mitigation strategies
• Leverages applicable regulations and guidelines to resolve issues efficiently, as well as, utilizes feedback from vendors and investigator site interactions in the decision-making process
• Provides guidance and on-going training to CROs, vendors, investigators and study coordinators on study requirements and offers strategic input for study delivery
• Develops and implements Standard Operating Procedures (SOPs) and conducts training across the organization to relevant stakeholders as required

Qualifications: 

• Bachelor’s degree, preferably in nursing, science or health related field
• Minimum 6-years’ global clinical trial management experience for Phase 2 and Phase 3 trials, oncology experience a plus
• Strong working knowledge of FDA and/or EMA regulations (or relevant local regulations), ICH guidelines, including E6(r2), and GCP governance
• Demonstrated ability in leading and building clinical trials teams from the ground-up, including recruitment, development and retention of top industry talent
• Experience overseeing department and clinical trials budgets
• Led RFP processes in the selection and management of CROs/other vendors
• Excellent track record with FDA/EMA inspections
• Previous work experience developing, implementing and managing trial plans/SOPs, including navigating through operational changes/updates

Competencies:  

• Excellent written and verbal skills; strong technical writing skills
• Ability to examine functional issues from a broader organizational perspective
• Strong analytical and problem-solving skills
• Influence others to create a clear sense of direction in order to achieve deliverables
• Effective problem-solving skills; results oriented focus
• Ability to navigate ambiguity and changing priorities; flexible
• Successful experience in fast-paced entrepreneurial environments
• Fit with DNAtrix culture