Asklepios Biopharmaceutical (AskBio) is seeking a self-starting, hands-on individual to become an integral member of the team, contributing to the overall management of pre-clinical and clinical gene therapy programs. This person will play an instrumental role in organizing and advancing critical programs for AskBio and/or its subsidiaries with approximately 25% of time spent on internal project management and approximately 75% of time spent on external study and partnership development and program coordination. Major Responsibilities • In partnership with the director of PM and departmental leaders, manage gene therapy program development with a focus on pre-clinical and clinical trial activities • Ensure coordination of activities and deliverables across all functions, including program planning, milestone tracking, meeting management/minutes, and internal reporting • Develop and implement clinical program management best practices and associated tools • Collaborate cross-functionally to develop and manage the program budgets, including resource tracking and scenario planning • Ensure communication flow between internal project teams, founders and other outside collaborators to maximize scientific outcomes and progress • Coordinate external study with CROs as needed • Coordinate research and clinical candidate production with CMOs as needed
REQUIRED EXPERIENCE • Must have experience advancing therapeutic programs and 3-5 years of relevant biotech or clinical-stage pharma industry experience. (ideally as an AAV bench scientist, RA department supervisor/manager, or high-level process technician in a clinical stage AAV environment) • At least 1-3 years’ experience in project management or a role that demonstrates project management skill and ability in taking a gene therapy product from pre-clinical to clinical development and regulatory submission • CAPM or PMP certification, or willingness to sit for PMP exam • Experience coordinating cross functional activities through IND submission • Operational experience and familiarity with the drug development process, including function-level activities and external regulatory requirements • Experience setting and maintaining budgets • Knowledge of orphan drug designation and/or accelerated approval pathways specifically related to gene therapy • Preferred – knowledge of upstream/downstream pharmaceutical manufacturing processes
KNOWLEDGE SKILLS AND ABILITIES • Ability to influence and get results from stakeholders across multiple functions and levels • Extreme attention to details of schedule, cost, risk for individual projects and overall programs • Demonstrated ability to work with different personalities and styles and efficiently prioritize activities based on ambiguous and quickly changing information • Excellent communication skills; comfortable navigating complexity in a fast-paced environment and apply organization and structure where none exists • Knowledge of project management tools (SharePoint, Microsoft Project, Excel, PowerPoint, Visio)
Additional Salary Information: Commensurate with experience
Asklepios BioPharmaceutical, Inc. (AskBio) was founded in 2003 by Richard Jude Samulski, PhD, and Sheila Mikhail in Chapel Hill, North Carolina to take advantage of the deep gene therapy resources in the Research Triangle Park area. AskBio has since set the standard for gene therapy clinical development including a deep portfolio of intellectual property in gene therapy for multiple disease and an... advanced manufacturing process. AskBio has established and formed industry alliances for multiple spin out companies and continues to pursue new gene therapy technologies and treatments.
AskBio owns and operates a cell line manufacturing process and an extensive capsid library and has generated hundreds of proprietary third generation gene vectors. AskBio’s double strand adeno-associated virus vectors (AAV) have a low effective dose, more cell type specificity and less potential systemic effects. AskBio’s proprietary production line requires fewer resources and regulatory steps and has been used in seven clinical-grade productions, over 50 preclinical lots and over 4,000 grade lots.