NDA Project Management, Lead (Contractor)

Full Time
74 E. Swedesford Rd, Suite 100, Malvern, PA, US
2 weeks ago | Requisiton ID:1042

The NDA Project Management, Lead will lead an NDA filing project that supports Venatorx Pharmaceuticals, Inc. in preparing for launching its first product: Cefepime-Taniborbactam to treat complicated urinary tract infections (cUTIs). You will provide operational management and oversight of cross-functional deliverables from Clinical Development, Regulatory Affairs, CMC, Commercial, and Non-Clinical. The NDA Project Management, Lead will be responsible for planning projects and ensuring they are implemented on-time, on-budget, and to a high-quality standard. The focus will be on preparation for NDA submission in 2022-2023.


This is an onsite office-based 12-month contract position located in Malvern, PA. NOT REMOTE.


Description of Responsibilities:

  • Align cross functional team around clearly defined goals, priorities, and timelines for NDA filing
  • Create an integrated NDA filing project plan across the enterprise with clear milestones, deliverables, dependencies, and transparent reporting of progress 
  • Establish efficient and effective processes to coordinate communication and activities across the project team and maintain team member accountability.
  • Coordinate resource requirements across the project, proactively identify resource constraints, and facilitate prioritization and resource allocation decisions with leadership. Ensure priorities defined by senior leadership flow through to project activity across teams
  • Identify, prioritize, and manage risks to NDA filing project success. Escalate critical path risks to department and senior leadership, making recommendations and facilitating necessary problem solving and decision making to re-prioritize as necessary
  • Identify opportunities to accelerate progress and gain efficiencies. Challenge assumptions about timeline and resource requirements and identify creative approaches to project execution
  • Maintain real-time understanding of project timelines and status, and serve as central source of truth for all team members including senior leadership


Minimum Requirements:

  • Minimum of bachelor's degree in a bio-medical, science or related field
  • Minimum of 12 years experience working in drug development and at least 5 years in a project management capacity; infectious disease preferred
  • Excellent knowledge of project management discipline and its application to drug development; PMP certification strongly preferred
  • Proven track record managing the delivery of NDA and/or MAA filings
  • Advanced proficiency with project management tools including MS Project
  • Strong knowledge of GxPs and related regulatory frameworks


Additional Qualifications:

  • Strong stakeholder management and influence skills. Ability to motivate, manage conflict, drive consensus, and promote good communication and efficient decision-making
  • Strong communication and presentation skills, including at senior leadership level
  • Ability to manage details and complexity while maintaining a sense of the big picture
  • Exceptional meeting management capabilities, including advance preparation, facilitation, time management, and follow-up
  • Self-starter, resourceful, creative, driven, collaborative, and positive
  • Thrives in entrepreneurial environments with significant ambiguity/unknowns, a fast pace, and evolving team and organization
  • Ability to be onsite coming into the office

                           Equal Employment Opportunity/M/F/disability/protected veteran status