Associate Director, Translational Medicine Project Lead

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. This person will also 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.

• Point of accountability for the development and delivery of a comprehensive preclinical safety and pharmacology strategy for programs within the 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 the designated therapeutic area, including management/resolution of safety issues.
• Design, outsource, and conduct appropriate studies to support project progression and risk mitigate and resolve project challenges.
• Ensure delivery of Translational Medicine components of stage gate documentation, Nonclinical Overviews, 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.

• PhD with 6+ years of experience in toxicology, pharmacology, physiology, animal science, or related discipline; OR MS degree with 12+ years of experience in the same fields.
• Experience in the biotech/pharmaceutical industry in nonclinical drug discovery and/or development.
• Prior experience interacting with preclinical CROs.

• Experience with AAV, cell & 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 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.

Ask Bio Inc. (Ask Bio) 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 (919) 561‑6210 or sending us an email at