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 ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are an emerging biotech company focused on developing transformative oncology therapies. As we advance our clinical pipeline, we are seeking an Associate Director, TMF Operations to lead Trial Master File (TMF) operations across our oncology programs. This role provides strategic leadership and oversight of electronic Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process expertise, exceptional vendor oversight, and a strong foundation in inspection readiness and support.
Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics. The role involves collaborating with senior leaders and key stakeholders to establish, manage, and generate reports and analytics that support performance measurement, delivery optimization, and continuous improvement.
This position currently requires a minimum of three days onsite per week in Princeton, NJ. The company reserves the right to modify onsite requirements, including transitioning to full-time onsite, based on business needs.
Responsibilities Serve as area representative for the implementation of any systems or processes that would interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management
Oversee and support the registration, maintenance, and compliance of clinical trial postings on appropriate clinical trial registries (e.g., ClinicalTrials.gov) in coordination with the cross-functional team.
Qualifications Compensation and Benefits:The expected base salary range for this position is $140,000 - $180,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also 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, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.