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, 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+ yrs of experience in toxicology, pharmacology, physiology, animal science, or related discipline; OR MS degree with 12+ yrs 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 & 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