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 product candidate, detalimogene voraplasmid, 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 to BCG. Detalimogene voraplasmid 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
The Vice President of Medical Affairs will play a pivotal role in shaping the strategic direction of enGene. Key responsibilities include developing and executing comprehensive medical strategies that support clinical development, regulatory submissions, and commercialization efforts. In this leadership position, you will be responsible for overseeing the medical affairs function, ensuring alignment with the company's mission to deliver transformative therapies to patients.
Essential Duties And Responsibilities
- Strategic Leadership: Develop and implement the medical affairs strategy aligned with the company’s vision and pipeline objectives in oncology and gene therapy
- Stakeholder Engagement: Establish and maintain relationships with key opinion leaders (KOLs), clinical investigators, and other stakeholders to facilitate scientific exchange and support clinical research initiatives
- Medical Education: Develop and implement educational programs for internal stakeholders and external healthcare professionals to enhance understanding of our products and therapeutic areas
- Clinical Development Support: Collaborate with R&D and clinical development teams to ensure the successful execution of clinical trials and to inform strategic decisions based on medical insights
- Team Management: Build and lead a high-performing medical affairs team, providing mentorship and fostering a culture of collaboration and scientific excellence
- Regulatory Compliance: Ensure all medical affairs activities comply with regulatory requirements and industry standards, including proper communication of scientific data to the medical community
- Data Generation: Identify opportunities for real-world evidence generation and post-marketing studies to support the value proposition of our therapies
- Cross-Functional Collaboration: Work closely with clinical, regulatory, and product development teams to ensure alignment of medical affairs activities with overall business objectives
- Market Access Support: Collaborate with market access and reimbursement teams to provide medical input that supports payer engagement and formulary decisions
Required Experience And Qualifications
- MD, PhD, or equivalent advanced degree in a relevant field (Oncology or Urology preferred)
- Minimum of 10 years of experience in medical affairs, with at least 8 years in a leadership role within the biotech or pharmaceutical industry
- Proven expertise in oncology and gene therapy, with a strong understanding of the competitive landscape and regulatory environment
- Demonstrated success in developing and executing medical strategies that drive product development and commercialization
- Experience in managing and mentoring cross-functional teams
- Strong communication and interpersonal skills, with the ability to engage effectively with diverse stakeholders
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.
