Join DermTech and make a difference in dermatologic patient care.
We are dedicated to a common vision: enabling high-quality dermatology care by all healthcare practitioners. This vision drives us to find ambitious, dynamic individuals who thrive in a team-based environment and can help us take another step toward fulfilling that goal.
We are currently hiring for the following positions. When applying, please submit your resume and cover letter by e-mail to email@example.com. DermTech offers competitive salary, outstanding benefits, and a collaborative working environment. Join DermTech and make a difference in dermatologic patient care with our non-invasive breakthrough in cancer detection. DermTech Inc. is an Equal Employment Opportunity and Affirmative Action employer.
Clinical Trial Manager (CTM): San Diego
The Clinical Trial Manager (CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP and SOPs. The CTM leads the cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines. CRA II or CRA III with device experience, current ICH, cGCP and FDA regulation knowledge required.
- Leads clinical trial team in the planning, execution, and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines
- Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately in a timely manner
- Obtain and relay key study issues, status updates, and other study information to the clinical trial team and management
- Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
- Provides input on the development of CRF design
- Participates in IRT, EDC and ePRO user acceptance testing
- Participates in data cleaning, listing, and report output reviews
- Develops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materials
- Participates in protocol deviation listing reviews and meetings
- Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments
- Participates in the protocol, table, figure, data listings, and clinical study report reviews
- Develops presentations for clinical sites, team and investigator meetings
- Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit-ready
- May be responsible for a defined region, vendor or process across a program
- Bachelor’s degree
- 6+ years of relevant and progressive clinical trial management experience
- Strong experience utilizing CTMS, EDC, TMS and related software
- Prior experience in management and monitoring of CRO and investigative sites
- Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay development regulations
Lab Technician or Research Associate: San Diego
- Conduct molecular diagnostic product development tests under direct supervision
- Perform biological sample nucleic acid extraction, RT-qPCR and data analysis
- Interact with team members to prioritize requests and deadlines
- Hands-on experience in nucleic acid extraction, RT-qPCR and general molecular biology techniques
- Familiar with Microsoft Office programs, including Word, Excel and Power Point
- Be able to write up experiment result reports or summaries, and protocols when needed
- Bachelor’s degree (or higher) in biological sciences
- Capable of managing time efficiently to meet project timelines
- Capable of working independently and collaboratively with team members
- Detail-oriented, organized, able to implement protocols (or following instruction)
- Full time
- Temp first (6 months), extension possible.
- Salary and job title depend on experience
Clinical Laboratory Scientist: San Diego
The successful candidate will ensure that complex molecular diagnostic assays and systems are performed under appropriate CLIA compliance and regulatory requirements. The Clinical Laboratory Scientist independently performs clinical lab testing and other scientific examinations, record appropriate test documentations, and evaluates test results.
Essential Duties and Responsibilities:
- Perform extraction techniques involving DNA/RNA, PCR and RT-PCR reactions, qPCR and RNA/DNA sequencing.
- Identify problems that may affect test performance or results and, following established protocols, correct problems or escalate to Clinical Laboratory Manager, technical supervisor, clinical consultant or lab director.
- Performs all aspects of laboratory procedures following safety guidelines and adhering to protocols as it pertains to health and safety policies and procedures.
- Comply with all local, state, and federal laws and regulations governing clinical laboratory operations.
- Responsible for assigned projects (instrument comparisons, instrument calibrations, staff schedules, process improvement, lab training and competency, assay or instrument validation, etc.).
- Performs other related duties as required or assigned in the laboratory.
- Bachelor’s degree in a scientific discipline such as Biochemistry, Biology, Genetics, etc. required.
- California Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) License required.
- 1-2 years clinical laboratory experience with RNA/DNA extraction, qPCR, RT-PCR, and DNA sequencing. Other molecular techniques a plus.
- Experience working with lab automation and LIMS systems.
- Must have an exceptional understanding of general laboratory techniques and medical terminology with emphasis for the department specific techniques.
- Ability to demonstrate excellent time management skills.
- Ability to handle biological samples and potentially hazardous chemicals.
- Ability to operate equipment with proficiently to successfully execute test procedures.
- Computer skills and laboratory automation knowledge.
- Exceptional ability to communicate effectively and follow written and verbal instructions.
- General office and laboratory environments. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Maintains a clean, neat, and orderly work area.
- Adheres to Department Specific Safety Guidelines.
- Standing, sitting, walking, bending, reaching, manual manipulation with hands (pipetting), and lifting up to 25 pounds.
Scientist/Senior Scientist: San Diego
We are currently looking for a highly motivated and experienced scientist to add to our R&D team to accelerate the research and development of new molecular analysis products in our pipeline. This individual will join a team to focus primarily on developing new products on our non-invasive molecular analysis platform for a variety of skin conditions (cancers, inflammatory and cosmetics), but may also have the opportunity to serve as technical lead to explore new technologies to overcome technical challenges encountered in the process of product development or serve as project coordinator to manage on-going internal or external collaboration projects.
- Ph.D. in molecular biology, biochemistry, genetics or related field in biological sciences, with postdoctoral training in cancer research (cancer marker gene screening and identification) a plus
- 3-5 years of industrial experience in research and development of molecular diagnostic products, and familiar with commercial diagnostic product development process, documentation and transfer to clinical applications
- Good knowledge of both basic and the latest nucleic acid analysis methodologies, including NGS (WGS, WGBS, RNA-seq and Sanger sequencing, etc.) for gene expression, genomic and epigenetic studies
- Extensive hands-on experience on nucleic acid isolation, quantification and amplification, allele-specific PCR assay design and development, Sanger sequencing and RNA-seq
- Ability to independently conduct product research and development work in the lab using sound scientific approaches (design and perform test, and analyze the test results with appropriate statistical tools), and to provide support or supervision for laboratory associates performing product development tests
- Ability to write or edit technical documents (application notes, product user guides, SOPs and manuscripts, etc.) and present study results at meeting
- Ability to manage internal or external collaboration projects (coordinate internal resources, plan, execute and update the work progress verbally and in writing, and interact with collaborators)
- Full time
- Job title and salary will depend on qualification and experience