Senior Study Startup Specialist

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.The Senior Study Startup Specialist is responsible for leading complex and/or global study start-up activities across the clinical portfolio in a fast-paced biotech environment. This role serves as a subject matter expert (SME) in site activation strategy, regulatory submissions, and start-up process execution, and provides mentorship and guidance to junior Study Start-Up Specialists. The Senior Specialist drives timely site activation and enrollment readiness in compliance with ICH-GCP, SOPs, and local regulatory requirements, while identifying and mitigating risks, optimizing activation timelines, and setting standards across the function. This position plays a critical role in enabling the success of SystImmune's oncology clinical development programs.This role is hybrid and requires 3 days (minimum) onsite at our Princeton, NJ location. ResponsibilitiesLead and oversee study start-up activities for complex, multi-site, and/or global clinical trials, ensuring timely site activation and enrollment readinessServe as the subject matter expert (SME) for study start-up across cross-functional teams, providing guidance to clinical operations, regulatory affairs, CRAs, and clinical sitesDevelop and execute site activation strategies that optimize timelines, reduce cycle times, and address risks in resource-constrained or ambiguous environmentsOwn and escalate start-up risks to leadership; propose mitigation strategies and drive resolution across functionsPrepare, review, and submit complex regulatory documents to IRBs, ethics committees, and regulatory authorities (IND, IRB/EC submissions, FDA forms, country-specific filings)Lead contract and budget negotiations with clinical sites in partnership with legal, finance, and clinical operations stakeholdersSet standards and drive continuous improvement for SSU processes, SOPs, templates, and tools; lead process improvement initiatives and contribute to scalable SSU infrastructureProvide CRO oversight for start-up deliverables, including quality reviews, KPI tracking, and issue escalationTrack and report start-up milestones (site activation timelines, enrollment readiness, submission approvals) to study teams and senior leadershipEnsure the eTMF and all study documentation are audit- and inspection-ready; support regulatory inspections and audits as neededApply advanced understanding of oncology clinical development to inform SSU planning, site feasibility, and execution strategyStay current on evolving global regulations (ICH-GCP, FDA, EMA, GDPR, local requirements) and adapt processes accordinglyCommunicate complex start-up issues clearly and concisely to senior stakeholders, including written status updates and risk summariesDrive continuous process improvement initiatives by identifying inefficiencies, recommending solutions, and implementing standardized workflows to improve cycle times, quality, and inspection readinessMonitor metrics and KPIs related to start‑up performance, leveraging trends and lessons learned to refine processes and inform risk mitigation plans on current and future studiesCoach and mentor junior study startup specialistsQualificationsBachelor's degree in Life Sciences, Nursing, Business, or related field required; advanced degree preferredMinimum 5-8 years of progressive experience in clinical study start-up, site activation, or regulatory submissions within the biotech, pharmaceutical, or CRO industryDemonstrated experience leading start-up for complex and/or global clinical trialsOncology clinical trial experience required; experience with biologics, bi-specifics, ADCs, or cell therapy programs strongly preferredDeep working knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements for clinical trial initiationProven experience mentoring and developing junior team membersAdvanced proficiency with CTMS, eTMF, and clinical trial platformsStrong contract and budget negotiation experienceExceptional organizational, project management, and risk-management skillsAbility to thrive in a fast-paced, ambiguous startup environment and pivot quicklyStrong written and verbal communication skills; able to communicate complex issues to senior stakeholdersDemonstrated ability to drive process improvements and set standards across SSU functionCompensation and Benefits:The expected base salary range for this position is $90,000 - $115,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.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.