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|Job Category :
||Director of Toxicology
||ADARx Pharmaceuticals in San Diego, CA 92121
|Job Description :
||Company Overview: At ADARx Pharmaceuticals, we focus on developing novel RNA based therapeutics for editing, cleavage, and inhibition of mRNA transcripts. We discover and develop innovative therapeutics that can precisely target mRNA. Our mission is to provide effective and safe therapeutics to patients who suffer from currently undruggable diseases.We are well-financed by a syndicate of renowned VC firms. We recently successfully closed our Series B fund raising. Our well-equipped facility is located in San Diego, California.We are seeking an exceptional Director of Toxicology to lead our exploratory and GLP safety pharmacology and toxicology activities to drive multiple cutting-edge RNA therapeutic discovery programs into clinical development. The incumbent will be responsible for all aspects of non-clinical safety including the design, oversight, and interpretation of non-clinical toxicology and investigational safety studies, identification and management of external CROs, and for authoring regulatory documents, including relevant sections of IND and CTA submissions. The successful candidate must have the ability to multi-task and function effectively in a fast-paced environment.Responsibilities: Collaborate with internal project teams and leadership to develop integrated non-clinical safety pharmacology and toxicology strategies.Plan, design and oversee all non-clinical safety studies, including exploratory and GLP studies.Identify and select high quality CROs, manage contracts and coordinate activities for the conduct of non-clinical safety studies.Critically evaluate, interpret, summarize, and present all non-clinical safety data to internal project teams and leadership.Responsible for 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.Qualifications: PhD in Toxicology, Biology, Pharmacology or related scientific discipline with 10+ years of relevant pharmaceutical or biotech industry experience.Board certification (DABT) is highly desired.Proven track record in designing and executing non-GLP and GLP toxicology studiesSuccessful experience in working with health authorities on IND filingExpert knowledge of GLP/ICH guidelines, FDA regulations and guidance, and demonstrated ability to develop GLP toxicology strategies that support the clinical development of drug candidates.Experience in toxicology development of oligonucleotide-based therapies is desired, but not required.Extensive knowledge and experience contracting and managing non-clinical safety studies with CROs.Experience in authoring non-clinical safety pharmacology and toxicology sections of regulatory submissions.Excellent interpersonal, organizational and communication skills with the ability to work effectively in a dynamic and collaborative environment on cross-functional projects.Ability to function independently in a fast-paced environment and make quick, but thoughtful decisions.Experience writing nonclinical sections of regulatory documents and regulatory interactionsCompensation: Pay commensurate with experience401k with company matchMedical, Dental, Vision, Life Insurance, FSA, Employee Assistance Program, Employee Discounts Performance based bonusesPTO and HolidaysWork Authorization: United States (Required)Background CheckADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.Job Type: Full-timeBenefits:401(k)401(k) matchingDental insuranceEmployee discountFlexible spending accountHealth insuranceLife insurancePaid time offVision insuranceSchedule:8 hour shiftMonday to FridayOvertimeSupplemental Pay:Bonus payEducation:Doctorate (Required)Experience:Biotechnology: 2 years (Required)Pharmacology: 2 years (Required)Work Location: One location
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