Director/Senior Director, Clinical Development

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, alongside a robust preclinical pipeline of potential cancer therapeutics in the discovery and IND-enabling stages.

About the role

SystImmune is seeking an experienced Director/Senior Director of Clinical Development to lead the direction, planning, execution, and interpretation of clinical trials within the Clinical Development program. This role involves collaborating across functions to deliver high-quality clinical data that supports product development, regulatory submissions, and business strategy.

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.

Qualifications

• M.D. or equivalent (international degrees accepted).
• Minimum of 2 years of experience in medical monitoring of oncology clinical trials; phase 1/2 required, phase 3 experience preferred.
• 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.

Pay

The expected base salary range for this position is $230,000 - $300,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.

Benefits

• 100% paid employee premiums for medical, dental, and vision insurance.
• Short-term disability (STD) and long-term disability (LTD) insurance.
• 401(k) plan with a 50% company match of up to 3% and a vesting schedule of 5 years.
• 15 PTO days per year, sick leave, plus 11 paid holidays.