:We are looking for experienced and motivated toxicology study monitor to Discovery and Development toxicology activities.The level of the selected candidates will be determined based on the experience of the candidate.Responsibilities: Identify high quality CROs, manage contracts, coordinate and oversee CRO activities for non-clinical safety and toxicology studies (non-GLP and GLP).
Work closely with CROs to align expectations between the ADARx and CROs, and ensure high quality and timely deliverables are met Collaborate with internal ADARx functional teams and leadership to execute non-clinical safety pharmacology and toxicology studies.
Communicate toxicology timelines, data, and other deliverables to stakeholders Coordinate and assist the preparation of safety pharmacology and toxicology sections of regulatory documents (IND, CTA, FDA briefing documents, Investigator brochures, etc.) Maintain a current knowledge of regulatory guidance, industry standards and recommendations, and relevant literature and methodologies specific to the non-clinical safety of oligonucleotide-based therapeutics.Requirements / Qualifications: BS or MS in Toxicology, Biology, Pharmacology or related scientific discipline with 5 years of experience in relevant biopharma industry, or Ph.D.
with 2 years of experience.
Extensive knowledge and experience contracting and managing non-clinical safety studies with CROs is required Excellent interpersonal, organizational and communication skills with the ability to work effectively with external partners (CRO) and multiple ADARx functional teams is required Knowledge of GLP/ICH guidelines, FDA regulations and guidance, and demonstrated ability to develop non-clinical safety strategies that support the clinical development of drug candidates is desirable Experience writing nonclinical sections of regulatory documents and regulatory interactions is desirableCompensation This is a full-time position Pay commensurate with experience 401k with company match Medical, Dental, Vision, Life Insurance, FSA, Employee Assistance Program, Employee Discounts Performance based bonuses PTO and HolidaysWork authorization: United States (Required) Background CheckADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.