ChromaCode is looking for an exceptional Clinical/Scientific Affairs professional to spearhead the establishment of these functional areas at ChromaCode. To be successful, you’ll need the mentality to thrive in ambiguity, a track record of developing successful processes from scratch, and the ability to execute with minimal supervision. Experience working with real-time and digital PCR technology is a major plus.
The person filling this role will have proven experience in cross-functional alignment. You will work cross-functionally across the organization and will be the liaison to partner CROs.
Who we are
We are a well-funded, multiplexed molecular diagnostics start-up with a bioinformatics focus and pedigree from Illumina, Google[x], Luminex, and Caltech. We leverage patented mathematical methods and algorithmic enhancements to enrich signal processing from the most popular life science instrumentation. We are using this to extract new information on biochemistry reactions and substantially increase the performance capabilities of today’s gold-standard biochemical assays at a very low cost.
What you will be responsible for
- Creating, authoring, and implementing processes/area SOPs for Clinical Affairs and Scientific Affairs
- Collaborating with Regulatory and liaise with partner CROs in the design and execution of clinical trials, including adherence to GCP
- Clinical Affairs core team representation
- Writing scientific communications, including white papers, abstracts, data summaries, and publications, interfacing with KOLs
- Work with the R&D team to ensure procurement of specimens for development & verification studies
- Lead the clinical sample management team to ensure the sample needs of and external testing are met
- Supporting study execution for alpha/beta testing sites, as well as external verification sites
- Collaborate with the Scientific Affairs Committee to design and support studies to meet commercial operations needs
- Collaborates with Legal and Regulatory to ensure NDAs, proper , and financial agreements for external studies
Your ideal qualifications
- A BS, MS, or PhD in the Life Sciences (Biology, Molecular Biology, Biochemistry) or another relevant field
- Five or more years in Clinical Affairs with demonstrated increasing responsibilities including study design, , budgeting, monitoring, and creative contingency planning
- Minimum 3 years of supervisory experience
- Extremely organized, results oriented, and energized by a fast-paced environment
- Highly collaborative and driven to understand organizational needs to set the team up for success
- Strong communication skills – oral and written – to enable meaningful and timely dissemination of scientific study results to a variety of audiences including stakeholders, trade show talks, abstracts, webinars and posters
- Experience in analysis of complex data sets
- Experience working in a startup environment
- This position will be based in Carlsbad, California