Head of Clinical & Data Sciences

Job Description

Job DescriptionenGene (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.
ROLEThe Head of Clinical & Data Sciences is a leadership role responsible for shaping, directing, and overseeing the clinical and data science strategy across the company’s development portfolio. This individual integrates clinical science, biostatistics, data management and advanced analytics to drive data‑informed decision‑making from first‑in‑human studies through global regulatory submissions.
The role requires deep experience in clinical trial design, complex data interpretation, regulatory strategy, and cross‑functional leadership, with a demonstrated track record of global submissions, regulatory interactions, end‑to‑end program ownership, and organizational leadership. ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.

SKILLS

• Exceptional scientific judgment integrating complex datasets into program‑shaping decisions.
• Strong command of global regulatory frameworks and expectations across phases.
• Ability to operate at both strategic and execution levels in a fast‑paced environment.
• Highly effective communicator with ability to influence senior leaders and regulators.
• Proven leadership and mentoring skills within multidisciplinary scientific teams.

REQUIRED EXPERIENCE AND QUALIFICATIONS

• Advanced degree required (PhD, PharmD, MD, or equivalent).
• 8+ years industry experience in clinical development, clinical science, or quantitative sciences.
• Significant global submission experience in oncology or urology disease area with direct leadership of key modules. Experience in bladder cancer disease area is preferred.
• Demonstrated leadership in designing and executing complex Phase I–III clinical trials.
• Experience leading scientific interactions with global health authorities.
• Deep understanding of biostatistics, data management, and real‑world data integration.
• Experience building and managing high‑performing scientific and data teams.

Location: USA Boston Massachusetts Salary: The salary range for this role is $345,000.00 - $415,000.00The base salary range provided represents a good faith estimate of the compensation for this position at the time of posting. Actual compensation will be determined based on a number of factors, including, but not limited to, relevant skills, experience and education. 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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.