Associate Director, Translational Medicine Project Lead

Asklepios BioPharmaceutical, Inc. (AskBio) • Durham, NC

23h • Onsite

About The Position

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: 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. 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.

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

Nice To Haves

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level