Manager, Program Management, CNS Delivery & Devices

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

1d•Hybrid

About The Position

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