enGene

Data Scientist

• Provide scientific leadership across all clinical programs from early development through late‑stage global registrational trials.
• Oversee authorship, development, and strategic review of protocols, IBs, SAPs, CSRs, DSURs, ICFs, eCRFs, and clinical modules of major submissions.
• Lead global regulatory interactions (FDA, EMA, MHRA, PMDA), including briefing docs, written responses, and meeting preparations.
• Direct quantitative strategy across programs, integrating clinical data, real‑world evidence, model‑informed drug development, and exploratory biomarker analyses.
• Ensure robust data quality, oversee scientific data reviews, and resolve complex data issues.
• Lead scientific strategy for regulatory submissions (IND, CTA, BLA, MAA, sBLA/sNDA).
• Drive scientific publication strategy and represent the company in scientific forums.
• Provide leadership to Clinical Scientists, Statisticians, and cross‑functional partners.

Head of Clinical and Data Sciences

Payroll

• Process semi-monthly payroll for employees using ADP, ensuring accuracy and compliance
• Administer employee benefits programs
• Serve as primary point of contact for payroll and benefits inquiries
• Oversee full-cycle accounts payable
• Prepare and post payroll, benefits, AP, and expense-related journal entries in NetSuite
• Assist with month-end and year-end close activities
• Collaborate cross-functionally with HR, Finance, and Operations teams

Senior Payroll, Accounting Specialist

Compliance

• Lead the day-to-day regulatory operations activities across assigned programs, ensuring timely, high-quality submissions to global regulatory agencies (FDA, EMA, etc.). Responsibilities include providing advice on content and structure of submissions, attending meetings, providing templates, and formatting and publishing documents.
• Oversight of enGene’s eCTD vendor. Responsibilities include ensuring formatting, publishing, and submission of document quality for INDs, NDAs, BLAs, CTAs, MAAs, adherence to Agency regulations/guidance.
• Create Regulatory Operations process Checklists, User Guides, SOPs and Work Instructions.
• Schedule, monitor, and track Regulatory submissions to ensure corporate and health authority deadlines are met.
• Management of submissions archives and correspondence.
• Serve as subject matter expert on regional and technical submission requirements and regulatory document formatting.
• Collaborate cross-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance.

Manager/Senior Manager, Regulatory Affairs Operations

QA Engineer

• Perform batch record review and facility issue resolution with GMP partner sites (CDMO).
• Conduct final disposition of clinical and commercial drug product, ensuring that disposition is conducted in compliance with applicable regulations and requirements. Includes coordination with QPs as required.
• Manage processes for demonstrated quality oversight of GMP partner sites, including partner investigations, CAPA and change controls. Identify and communicate quality and compliance risks to senior quality management and participate in determination of appropriate plan to address such risks.
• Support GMP inspections and audits at company’s GMP partner sites.
• Support the development and maintenance of procedures and quality systems for GMP operations.
• Support compilation of quality performance and compliance metrices as relates to product disposition and GMP partner site operations.
• Responsible for providing operational support for key quality systems (e.g. risk management, complaints, document management, training, and change control).
• Trend metrics related to non-conformances/CAPAS, training compliance at partner sites along with product disposition metrics.
• Represent quality input at internal cross functional and CDMO meetings.

Head of Clinical and Data Sciences

Senior Payroll, Accounting Specialist

Manager/Senior Manager, Regulatory Affairs Operations

Senior Specialist, Quality Assurance Operations