AskBio Inc

Associate Director, Translational Medicine Project Lead

Durham, NC · Director

Sponsorship not specifiedDetected 31 days ago

RecruitingPharmacologyFDA RegulatoryCRISPRResearchAnimal StudiesLeadershipProblem SolvingWriting

About the role

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
Address and resolve efficacy and/or toxicological issues arising in drug development programs and adequately assess the relevance of these findings to human safety

In addition, this person will be expected to have expertise to support the Translational Medicine team in Bioassays, Biomarker, Pharmacology, Toxicology or Pathology.
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
Pioneering science to create transformative molecular medicines.

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
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
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
Proven ability to work independently and be self-motivated

Lead innovative science and drive clinical outcomes to transform people's lives.
Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
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

This listing is sourced directly from AskBio Inc's careers page and normalized into a canonical job model.