Associate Director, Translational Medicine Project Lead

Position Summary The Associate Director; Translational Medicine Project Lead will provide scientific guidance for specific therapy areas (CNS, Muscle Metabolism, Renal, Ophthalmology) to represent the Translational Medicine function on program teams. In addition, this person will be expected to have expertise to support the Translational Medicine team in Bioassays, Biomarker, Pharmacology, Toxicology, or Pathology. This position is based in Morrisville, NC and reports to the Senior Director, Translational Medicine Project Lead. Job Responsibilities Point of accountability for the development and delivery of a comprehensive preclinical safety and pharmacology strategy for programs within their designated therapeutic area. Expertise in either CNS, Muscle Metabolism, Ophthalmology, or Renal disease. Matrix leadership to ensure Translational Medicine resources are effectively deployed to support programs within their designated therapeutic area, and management/resolution of safety issues. Design, outsource and conduct appropriate studies to support project progression and to risk mitigate and resolve project challenges. Ensure delivery of Translational Medicine components of stage gate documentation, Nonclinical Overviews and Investigator Brochures, and other regulatory documents. Review and endorse regulatory responses and participate in Regulatory Agency interactions, as required by program. Lead the development of new or innovative solutions to meet business needs and enhance the company’s research productivity or competitive advantage. Address and resolve efficacy and/or toxicological issues arising in drug development programs and adequately assess the relevance of these findings to human safety. Minimum Requirements PhD with 6+ years of experience in toxicology, pharmacology, physiology, animal science, or related discipline; OR MS degree with 12+ years of experience in toxicology, pharmacology, physiology, animal science, or related discipline. Experience in the biotech/pharmaceutical industry in the area of nonclinical drug discovery and/or development. Prior experience interacting with preclinical CROs. Preferred Education, Experience and Skills Experience with AAV, cell and gene therapies drug discovery and development. Strong understanding of FDA, EMA, and ICH regulatory guidance in drug development and in-depth understanding of GLP guidelines internationally. Analytical and problem-solving skills used to lead troubleshooting in all areas of preclinical development. Highly refined writing skills that complement and advance intellectual contributions for convincing audiences of scientific expertise. Excellent presentation skills with the ability to efficiently relay information to project teams and other key stakeholders. Ability to develop relationships in a matrix environment and comfortable having robust discussions with sector leads, key stakeholders, and senior management to ensure that project, scientific, and resource demands are aligned. Strong leadership and team management skills. Proven ability to work independently and be self‑motivated. Flexibility to work across multiple projects in a fast‑paced environment. Equal Opportunity Statement AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‑related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at View phone number on click.appcast.io or sending us an email at View email address on click.appcast.io. #J-18808-Ljbffr Dormont Manufacturing Co