Vice President, Program Management

enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program EG-70 is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG). EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com.

Role

We are seeking a Vice President, Program Management to lead and coordinate cross-functional planning of enGene’s drug development programs in both late and early phases with late-stage development and regulatory submissions experience (e.g., NDAs, MAAs). The Vice President, Program Management will report to the President, Chief Operating Officer. The position involves close coordination with stakeholders across Clinical Development, Clinical Operations, CMC, Non-Clinical, Regulatory Affairs, QA, Finance and Legal.

Responsibilities

• Lead program management activities for enGene’s EG-70 (detalimogene voraplasmid) product candidate across all clinical programs, including registration for lead indication of BCG-unresponsive NMIBC with Cis
• Guide the cross-functional product team through late-stage clinical development by collaborating to execute an integrated development plan through registration
• Work with technical operations/CMC, clinical operations, regulatory, and commercial to ensure critical functional activities are fully integrated into the product development plan
• Achieve organizational alignment and seamless execution by working cross functionally within enGene and with our selected CROs. Develop strong working relationships with key external stakeholders
• Define critical path, at-risk activities, and inter-dependencies. Anticipate bottlenecks, and clear barriers to progress program level scenario planning and risk management
• Identify, track, and support resolution efforts for all program-related issues
• Relay deviations from program plans to the program team and management
• Coordinate and lead regulatory project-team meetings. Facilitate clear presentation of action items and critical path deliverables, calling for and driving action if required
• Serve as liaison to C-suite and executive leadership team for program-level topics
• Track program progress against the plan, working with department heads to identify and resolve resource constraints consistent with corporate priorities
• Support active portfolio management (budget, resources, stage-gates where relevant) and decision making; monitor progress of portfolio/program strategy, goals, and metrics
• Ensure uniformity between programs including agendas, meeting minutes, and other program documentation.
• Preparation of materials for C-suite and BoD as needed
  
  
  
  

Experience And Qualifications

• Bachelor's degree in science or related field and an advanced degree MS/PhD preferred
• At least 10 years of relevant biotech or pharmaceutical industry experience with 5-7[AN1] + years in program management. Deep functional experience in CMC, commercialization, or late-stage regulatory preferred
• Hands on experience in leading program management activities for global oncology or urology programs in early and late stages of clinical development, ideally through registration.
• Oncology or urology experience required
• Portfolio management/strategic Planning/risk management experience required, with experience in risk analysis, decision analysis, and contingency planning
• Strong facilitation, negotiation, and dynamic communication skills across various functions and levels of governance
• Excellent written and verbal communication. Must be able to clearly and concisely communicate complex program information in both formal and informal settings, both verbally and in presentation media
• Experience setting and maintaining budgets
• Able to handle complexity and ambiguity as well as be able to prioritize effectively
  
  
  
  

enGene USA Inc. is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. At enGene USA Inc., we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.