Associate Director/Director, Clinical Operations
About DNAtrix: DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer. Its proprietary adenovirus platform is based on an engineered version of the common cold virus that is designed to selectively infect and kill cancer cells while leaving healthy cells unharmed. The company's lead product candidate is DNX-2401, which is expected to enter into a global pivotal Phase 3 clinical study for patients with recurrent glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study for diffuse intrinsic pontine glioma, for which it has received FDA Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is entering a Phase 1 clinical study in patients with colorectal and other cancers with liver metastasis.
Position Summary: The Associate Director/Director, 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.
- Manages all aspects of DNAtrix's day-to-day clinical trial activities, including 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
- Travel domestically/internationally (10-15%)
- Bachelor's degree, preferably in nursing, science or health related field
- Minimum 8 to 10-years' global clinical trial management experience for Phase 2 and Phase 3 trials, oncology experience a plus
- At least 5-years of related clinical trial management experience with a pharmaceutical/biotech sponsor organization
- Strong working knowledge of FDA and 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
- Excellent written and verbal skills; strong technical writing skills
- Ability to examine functional issues from a broader organizational perspective
- Strong analytical 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's culture
This job description has been designed to indicate the general nature and level of work performed, and it is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
DNAtrix is an equal opportunity employer
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.