Head of Clinical & Data Sciences
Company: enGene
Location: Boston
Posted on: February 19, 2026
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Job Description:
Job Description Job Description 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 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 -
$415,000.00 The 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.
Keywords: enGene, Boston , Head of Clinical & Data Sciences, Science, Research & Development , Boston, Massachusetts
