Medical Director/ Senior Medical Director, Clinical Development

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 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. 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

Reporting to the Chief Medical Officer, the Director/Senior Medical Director Clinical Development will work to implement clinical strategies and operationalize in both programs and clinical trials. They will work on the design and execution of clinical trials from early to late-stage development through regulatory approval. This includes thorough data interpretation based on deep scientific and disease biology understanding, translation expertise and medical knowledge including patient safety and data integrity. The position provides a leadership opportunity to guide the clinical development of our lead asset through regulatory filings and commercialization. The Medical Director/ Senior Medical Director will be an important voice within the organization to help shape the clinical and scientific strategy for detalimogene voraplasmi . The individual will also be provided leadership and growth opportunities to further develop professionally.

Essential Duties And Responsibilities

• Devise strategy for, develop, and implement clinical studies for investigational medicines and new indications for approved medicines
• Work closely with other functional areas within R&D to facilitate the execution of clinical trials and programs
• Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs, and senior management
• Provide clinical/scientific input during the development, execution, and completion of clinical trials
• Interpret clinical trial data and prepare reports, regulatory submissions, and publications based on the results
• Monitor clinical trials for safety
• Work in conjunction with Product Safety to insure timely reporting of safety signals to regulatory authorities
• Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
• Serve as lead medical representative with regulatory agencies
• Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
• Lead clinical and/or patient advisory board meetings to obtain strategic input into clinical program development
• Serve as clinical and medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and business development and investor contacts
  
  
  
  

Skills

• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Must work well both independently and in teams, have excellent time-management skills and be able to work well under pressure.
• Possess scientific credibility and operational expertise
• Interpret complex clinical data
  
  
  
  

Required Experience And Qualifications

• Requires an MD degree, board certified/eligible; specialization in Urology or Oncology, is a plus.
• Several years of relevant experience within oncology in a biotech/pharmaceutical and/or academic environment, including leadership of clinical trial activities
• Previous experience conducting clinical trials in Oncology
• Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.
  
  
  
  

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.