enGene : Vice President, Medical Affairs
enGene (NASDAQ: ENGN) is a late-stage biotechnology company focused on mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs. Its lead product candidate, detalimogene voraplasmid, is currently being evaluated in a pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive to BCG. This candidate was developed using enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of various cargo types, including DNA and RNA. For more information, visit enGene.com.
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Role
The Vice President of Medical Affairs will play a strategic role in shaping enGene's direction. Key responsibilities include developing and executing medical strategies supporting clinical development, regulatory submissions, and commercialization. This leadership position involves overseeing the medical affairs function to ensure alignment with the company's mission to deliver transformative therapies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Strategic Leadership: Develop and implement the medical affairs strategy aligned with the company's vision and pipeline goals 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.
- Medical Education: Develop educational programs for internal teams and external healthcare professionals to enhance understanding of products and therapeutic areas.
- Clinical Development Support: Collaborate with R&D and clinical teams to ensure successful clinical trials and 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 excellence.
- Regulatory Compliance: Ensure all activities comply with regulatory standards and industry regulations, including proper scientific communication.
- Data Generation: Identify opportunities for real-world evidence and post-marketing studies to support therapy value propositions.
- Cross-Functional Collaboration: Work with clinical, regulatory, and product teams to align medical activities with business goals.
- Market Access Support: Collaborate with market access and reimbursement teams to support payer engagement and formulary decisions.
REQUIRED EXPERIENCE AND QUALIFICATIONS
- MD, PhD, or equivalent in a relevant field (Oncology or Urology preferred).
- Minimum of 10 years in medical affairs, including at least 8 years in leadership roles within biotech or pharma.
- Proven expertise in oncology and gene therapy, with a solid understanding of the regulatory landscape.
- Successful track record in developing and executing medical strategies for product development and commercialization.
- Experience managing and mentoring cross-functional teams.
- Excellent communication and interpersonal skills for stakeholder engagement.
enGene USA Inc. is an Equal Opportunity Employer:
All applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. We are committed to fostering diversity and inclusion within our team, supporting cultural diversity and sustainability.
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