SystImmune · 11 hours ago
Director/Senior Director, Clinical Development
Princeton, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$230K/yr - $300K/yr
2+ years expSystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. The Director/Senior Director of Clinical Development will lead the planning, execution, and interpretation of clinical trials, ensuring high-quality clinical data that supports product development and regulatory submissions.
BiopharmaBiotechnologyProfessional Services
Responsibilities
Lead the design and implementation of clinical development programs grounded in sound medical and scientific principles, regulatory knowledge, and business objectives. Provide strategic medical input across the product lifecycle from early development through phase 3, for both internal and partnered programs
Oversee the execution and integrity of clinical trials. Collaborate with Clinical Operations to manage enrollment progress, timeline adherence, and delivery of key milestones. Proactively monitor trial safety in coordination with the Safety team, ensuring compliance with serious adverse event (SAE) reporting requirements
Drive the development and scientific accuracy of key clinical documents, including protocols, Investigator Brochures, Clinical Study Reports (CSRs), regulatory submissions, and response packages
Serve as the medical lead on clinical study teams, aligning medical strategy across functions. Act as a key clinical representative in regulatory interactions and ensure adherence to GCP, pharmacovigilance standards, SOPs, and global compliance requirements
Provide in-house clinical expertise on assigned compounds and indications. Actively engage with investigators and opinion leaders to inform development strategy and protocol design. Stay current on therapeutic area developments through continuous learning and participation in scientific forums
Qualification
Required
M.D. or equivalent (international degrees accepted)
Minimum of 2 years of experience in medical monitoring of oncology clinical trials; phase 1/2 required
Prior experience in clinical development or pharmaceutical/biotech settings
Proven track record in product safety oversight and clinical trial execution, particularly with biologics such as ADCs and immune-oncology agents
Strong foundation in clinical and drug development processes
Sound medical judgment with expertise in medical safety data interpretation
Preferred
phase 3 experience preferred
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
A 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
15 PTO days per year
Sick leave
11 paid holidays
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Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
H1B Sponsorship
SystImmune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2023 (1)
2022 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
Recent News
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