Manager, Program Management, CNS Delivery & Devices

AskBio•Durham, NC

1d•Hybrid

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 Manager, Program Management (CNS Delivery & Devices) plays an integral role in advancing AskBio’s CNS device and surgical delivery solutions by providing comprehensive program management and operational support, including creation and maintenance of integrated, end-to-end development plans and timelines. This role partners closely with functional leaders, SMEs, and stakeholders to ensure the team has clear direction and alignment on critical workstreams related to device development, non-clinical and clinical evaluations, and regulatory submissions. The ideal candidate also maintains effective partnerships with external teams supporting design, testing, manufacturing, and/or commercial activities. This is a hybrid role based near RTP, NC, Philadelphia, PA, or Edinburgh, UK and reports to the Head of Program Management Center of Excellence.

Requirements

Bachelor’s degree in a technical or life science discipline
6+ years of relevant industry experience industry, preferably in (CNS-related) medical devices, biotechnology, life science or pharmaceutical organizations
2+ years of experience in program/project management or performing PM-related duties
Experience leading cross-functional teams and supporting complex projects/programs
Practical knowledge of the biotechnology and medical device development lifecycles and the activities needed to support clinical development
Comfortable operating with ambiguity and identifying creative solutions
Effective problem-solving and analytical skills to manage a broad range of issues and projects and deliver innovative solutions
Able to communicate effectively across different disciplines (e.g., R&D, Translational, CMC) and experience levels, including Senior Management
Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment

Nice To Haves

Advanced degree (e.g., Master’s, Doctorate)
Previous experience developing CNS delivery device systems and/or neurosurgical workflows
Project Management Professional (PMP), or an equivalent certification
Previous experience developing advanced therapies, preferably gene therapies
Able to understand and interpret technical data related to medical device engineering, development, manufacturing, and testing
Experience working on/with global teams

Responsibilities

In partnership with the Device and Delivery leadership, define scope, objectives, and deliverables for workflows and/or device development projects
Create and maintain integrated development plans that accurately capture timelines, decision points (e.g., stage gates), resource needs, and budget
Track and coordinate cross-functional (e.g., clinical, regulatory, commercial) activities in support of proof-of-concept, clinical evaluation, registrational studies, and commercialization
Maintain alignment on plans and progress within the team and external vendors
Lead the team through exercises to ensure milestones are delivered according to plan, including risk identification/mitigation, proactive problem-solving, and contingency planning
Provide general operational support to the cross-functional teams, including risk identification/mitigation, problem-solving, and contingency planning
Deliver timely updates to key functional stakeholders, leadership, and governance boards covering program status, risks/mitigation, scope changes, etc.
Document meeting minutes, key decisions, risks/issues, and action items
Ensure the team communicates effectively and collaboratively, leveraging PM techniques to establish and maintain a high-performing team
Facilitate development of budgets, resource plans, and long-range plans
Ensure critical documentation is organized, accessible, and archived
Lead small projects and/or task forces independently with support from Device and Delivery leadership, SMEs, and functional leaders
Develop, implement, and champion PM best practices, processes, and strategies on the EPT and with supporting functions