Translational Project Lead
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.
- Advance innovative science by pushing boundaries.
- Bring transformative therapeutics to patients in need.
- Provide an environment for employees to reach their fullest potential.
- 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.
We have an opportunity for a Translational Project Lead to join the AskBio team and be part of our continued success!
The Translational Project Lead, reporting Vice President, Translational Medicine, will be responsible for providing scientific guidance for specific therapy areas (CNS, Muscle Metabolism, Cardiovascular) and leadership to represent the Translational Medicine function on program teams. The ideal candidate must have expertise and the ability to support the Translational Medicine either in Bioassay, Pharmacology, Toxicology or Pathology for ~40% of their time. The position is based at AskBio’s RTP, NC Headquarters Facility.
- Point of accountability for the development and delivery of a comprehensive preclinical safety strategy for programs within their designated therapeutic area.
- Expertise in either CNS, Muscle-skeletal or Cardiovascular 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.
- Ensures delivery of Translational Medicine components of stage gate documentation, Nonclinical Overviews, Investigator Brochures.
- Reviews and endorses regulatory responses and participates in Regulatory Agency interactions, as required by program.
- Forge strong partnerships (with sector leads, analytical development, product development) and build credibility to shape senior leader thinking on safety issues and collaborate internally and externally to deliver on functional/department/AskBio goals.
- 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.
Required Education and Experience
- PhD degree with 5-8+ yrs of experience or MS degree with 8+ yrs of experience in pharmacology, physiology, animal science, or related discipline.
- 5+ years of experience in the biotech/pharmaceutical industry in the area of nonclinical drug discovery and/or development.
- Strong understanding of FDA, EMA, and ICH regulatory guidance in drug development and in-depth understanding of GLP guidelines internationally.
- Prior experience working with preclinical CROs.
Preferred Experience and Skills
- Experience with AAV, cell & gene therapies drug discovery and development.
- Highly refined writing skills that complement advance intellectual contributions for convincing audiences of scientific expertise.
- Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment.
- Analytical and problem solving skills with the ability to lead troubleshooting in all areas of preclinical development.
- Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders.
- Strong presentation skills in order to efficiently relay information to project teams and other key stakeholders.
- Ability to have robust discussions with sector leads and key stakeholders to ensure that project, scientific and resource demands are aligned
Asklepios BioPharmaceutical, 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 (919) 561-6210 or emailing us at email@example.com.