DTx Pharma is seeking an enthusiastic and highly motivated individual to support our outsourced nonclinical activities. We are in search of a Nonclinical Operations Manager/Senior Manager with excellent communication skills, who will coordinate all operational aspects of outsourced studies for nonclinical safety and DMPK studies associated with the drug candidates in the DTx Pharma pipeline. This position operates within a fast-paced interdisciplinary environment, so flexibility and organizational skills are required.  The successful candidate will be responsible for activities such as:

Responsibilities

  • Managing external nonclinical operations for the Company’s development programs to include coordinating with internal subject matter experts and consultants in the planning and design of non-GLP and GLP external toxicology and DMPK studies with associated bioanalysis in support of clinical candidate selection and regulatory filings with appropriate cost, timing, and risk assessment
  • Managing external toxicology, DMPK, and analytical timelines, key data, and reporting deliverables to meet IND filing goals and project team objectives
  • Partnering with external consultants, operational counterparts, and CROs to coordinate and facilitate audits, study logistics/schedules/deliverables, and financial workflows
  • Coordinating cross-functional support activities such as formulations, drug supply, analytical, and bioanalytical work in support of nonclinical safety studies
  • Facilitating the timing and execution of bioanalytical, nonclinical safety, and DMPK studies for multiple programs managed through partner CROs and ensures contracted timelines are followed, in collaboration with the department scientific lead and external consultants
  • Initiating and managing contracts regarding bioanalytical, nonclinical safety and DMPK studies

Qualifications

  • Bachelor’s degree in a related field required
  • BS/BA plus 4 years of relevant and progressive experience; or
  • MS/MA plus 2 years of relevant and progressive experience; or
  • Significant experience partnering with CRO’s/vendors or study sponsors
  • Excellent computer skills (Excel, Word, PowerPoint)
  • Familiarity with GLP environments preferred

Company Overview:

DTx Pharma, Inc. is a privately held biotechnology company based in San Diego, CA creating novel RNA-based therapeutics to treat the genetic drivers of disease. The company’s proprietary delivery technology platform utilizes fatty acids as targeting ligands to enable the delivery of oligonucleotide therapies to tissues and cell types throughout the body. In preclinical studies, DTx has demonstrated cellular uptake and broad activity of oligonucleotides in the retina, muscle, heart, neurons, T cells, and other specialized cell types. To advance the FALCON platform toward and into clinical development, DTx has raised more than $100M in combined investment from several of the world’s leading healthcare investors including RA Capital Management and Access Biotechnology, pharmaceutical companies such as Eli Lilly and Company, the National Institute of Health (NIH), and research foundations such as the CMT Research Foundation (CMTRF). To learn more about DTx Pharma, please visit www.dtxpharma.com and follow DTx on LinkedIn and Twitter @DTxPharma.