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.

Responsibilities

• Lead and oversee study start-up activities for complex, multi-site, and/or global clinical trials, ensuring timely site activation and enrollment readiness.
• Serve as the subject matter expert (SME) for study start-up across cross-functional teams, providing guidance to clinical operations, regulatory affairs, CRAs, and clinical sites.
• Develop and execute site activation strategies that optimize timelines, reduce cycle times, and address risks in resource-constrained or ambiguous environments.
• Own and escalate start-up risks to leadership; propose mitigation strategies and drive resolution across functions.
• Prepare, 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 stakeholders.
• Set standards and drive continuous improvement for SSU processes, SOPs, templates, and tools; lead process improvement initiatives and contribute to scalable SSU infrastructure.
• Provide CRO oversight for start-up deliverables, including quality reviews, KPI tracking, and issue escalation.
• Track and report start-up milestones (site activation timelines, enrollment readiness, submission approvals) to study teams and senior leadership.
• Ensure the eTMF and all study documentation are audit- and inspection-ready; support regulatory inspections and audits as needed.
• Apply advanced understanding of oncology clinical development to inform SSU planning, site feasibility, and execution strategy.
• Stay current on evolving global regulations (ICH-GCP, FDA, EMA, GDPR, local requirements) and adapt processes accordingly.
• Communicate complex start-up issues clearly and concisely to senior stakeholders, including written status updates and risk summaries.
• Drive continuous process improvement initiatives by identifying inefficiencies, recommending solutions, and implementing standardized workflows to improve cycle times, quality, and inspection readiness.
• Monitor 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 studies
• Coach and mentor junior study startup specialists.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Business, or related field required; advanced degree preferred.
• Minimum 5-8 years of progressive experience in clinical study start-up, site activation, or regulatory submissions within the biotech, pharmaceutical, or CRO industry.
• Demonstrated experience leading start-up for complex and/or global clinical trials.
• Oncology clinical trial experience required; experience with biologics, bi-specifics, ADCs, or cell therapy programs strongly preferred.
• Deep working knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements for clinical trial initiation.
• Proven experience mentoring and developing junior team members.
• Advanced proficiency with CTMS, eTMF, and clinical trial platforms.
• Strong contract and budget negotiation experience.
• Exceptional organizational, project management, and risk-management skills.
• Ability to thrive in a fast-paced, ambiguous startup environment and pivot quickly.
• Strong written and verbal communication skills; able to communicate complex issues to senior stakeholders.
• Demonstrated ability to drive process improvements and set standards across SSU function.

Compensation 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 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.