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: DNAtrix is looking for a Sr. Clinical Scientist to join our Clinical Research Team. The Sr. Clinical Scientist is responsible for various aspects of DNAtrix's clinical trial (Phase 1-3) activities. These activities include but are not limited to; clinical study/start-up, execution and completion, as well as, data analysis/reporting, protocol development and amendments, including regulatory responses to domestic/international agencies. This position is based in San Diego, CA (or remote) and reports to the CMO; collaborates closely with the Medical Director.
- Serves as a key member of the Clinical Research team and provides scientific, clinical, and operational input to early and late-stage clinical development programs
- Works on cross functional teams with preclinical, operational, regulatory, safety, quality and biometrics
- Contributes to the development of clinical sections of regulatory documents including Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, study protocols, informed consents, statistical analysis plans, regulatory approval submissions, serious and non-serious adverse event evaluation, and supporting responses to Health Authorities questions.
- Performs review of emerging clinical data to identify issues with protocol compliance that may impact key study outcomes
- Maintains familiarity with standards of practice in the relevant therapeutic areas to contribute to strategic discussion and decision-making for the clinical studies and programs
- Develops effective working relationship with key investigators in assigned programs to optimize scientific quality / innovation of clinical study design, execution, reporting and publication
- Writes or reviews abstracts, posters, content for scientific meetings, conferences, or other publicly distributed materials, as well as prepares a variety of materials for internal use as needed for projects or presentations
- Creates training materials for sites and internal training on protocols and therapeutic subject matter
- Contributes to development of study materials such as CRFs, patient diaries, drug accountability forms and study reference manuals
- Travel domestically/internationally (10-15%)
- Masters, RN, PharmD or PhD degree preferred
- Minimum 8-years' experience in biotech or pharmaceutical industry
- Previous experience as a Clinical Scientist or similar role is essential
- The ideal candidate has experience in solid tumor oncology, with experience in the design and conduct of clinical studies in this therapeutic area
- Previous work experience with Phase 3 clinical trials, preferably in oncology
- Familiar with current approaches regarding oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory and operational requirements
- Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance
- Comprehensive knowledge of GCP, ICH, FDA, EMEA and other guidelines and regulations
- Excellent written and verbal skills; strong technical writing skills
- Team oriented and non-hierarchical; ability to inspire others
- Effective problem-solving skills; results oriented focus
- Ability to navigate ambiguity and changing priorities; flexible
- Outstanding attention to detail
- Creative and innovative thinker
- Operates with a high level of integrity
- Able to build and create good working relationships with internal/external stakeholders
- Strong business presentation skills; highly effective at summarizing and presenting the key considerations and decision points and influencing others
- Successful experience in a fast-paced entrepreneurial environment
- Fit with DNAtrix culture
DNAtrix is an equal opportunity employer.