Senior Study Start-Up Specialist

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we’re looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly-potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) indications.

Join us in building an organization where people and science thrive together. You’ll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone.

The Senior Study Start-Up Specialist is responsible for leading and coordinating global clinical trial start-up activities across Uniquity Bio’s clinical development programs to support the timely activation of clinical study sites across multiple studies and phases of development. This role serves as a key operational partner to Clinical Operations, CROs, Regulatory Affairs, Legal, vendors and investigative sites to ensure study start-up milestones, regulatory deliverables, and site readiness activities are executed efficiently, compliantly, and in alignment with study timelines, quality standards, and business objectives.

The ideal candidate brings strong biotech and CRO oversight experience, excellent organizational and communication skills, and the ability to proactively identify and mitigate start-up risks in a fast-paced evolving clinical development environment.

Key Responsibilities:

Study Start-Up & Site Activation

• Lead and coordinate study start-up activities from protocol finalization through site activation for global clinical trials
• Serve as the primary sponsor contact for CRO study start-up teams, providing oversight of timelines, deliverables, risks, and performance metrics to ensure successful study execution
• Develop and maintain study start-up trackers, timelines, reports, and metrics to support operational oversight, leadership visibility, and timely site activation
• Coordinate the collection, review, tracking, and maintenance of essential study and regulatory documents, including informed consent forms, investigator documents, financial disclosures, IRB/EC approvals, licenses, and site regulatory files
• Partner with CROs, investigative sites, and cross-functional teams to support timely site activation and study execution
• Monitor country and site activation metrics and proactively escalate risks, delays, or resource constraints with proposed mitigation strategies.
• Support vendor selection, contracting, and management related to study start-up activities.
• Participate in study team meetings and provide regular status updates, metrics, and executive-level communications regarding start-up progress.
• Identify, track, and escalate start-up risks, delays, or gaps with proposed mitigation strategies
• Partner with internal teams and external vendors to support timely site initiation

Regulatory Document & Trial File Support

• Support inspection readiness activities, audits, and sponsor oversight processes by maintaining compliant study documentation and operational processes
• Ensure documentation is maintained in alignment with ICH-GCP, SOPs and applicable regulatory requirements

Site, CRO & Vendor Coordination

• Serve as a key operational liaison across Clinical Operations, CROs, Regulatory Affairs, Legal, vendors, and investigative sites to ensure alignment, communication, and timely completion of study start-up activities
• Participate in study team meetings and provide updates on start-up progress, risks and next steps

Budget, Contract & Feasibility Support

• Support tracking of site budget and contract status during start-up
• Coordinate with internal stakeholders and external partners to help move contracts, budgets and start-up documents forward
• Assist with feasibility tracking, site identification support and site readiness activities as needed

Process Improvement & Operational Excellence

• Contribute to the continuous improvement of study start-up processes, tools, templates, and operational best practices to enhance efficiency and scalability
• Bring a proactive, solution-oriented mindset to a growing Clinical Operations function
• Support a culture of accountability, collaboration and continuous improvement

Required Education and Experience

• Bachelor’s degree required, preferably in life sciences, healthcare or related field
• 5+ years of clinical research, clinical operations or study start-up experience in biotech, pharmaceutical, CRO or clinical trial site environment
• Experience supporting Phase I–III global clinical trials.
• Experience overseeing CRO-managed clinical trials and working with external vendors and investigative sites
• Experience supporting clinical trial start-up activities, site activation or regulatory document management
• Familiarity with essential documents, IRB/EC submissions, site start-up packages and Trial Master File expectations
• Strong knowledge of clinical trial start-up processes, ICH-GCP guidelines, FDA regulations, regulatory documentation requirements, and clinical trial operational standards
• Knowledge of global regulatory submission requirements and country-specific start-up processes
• Experience participating in inspection readiness activities and sponsor oversight programs
• Strong project management, organizational, and problem-solving skills with the ability to manage multiple studies simultaneously
• Excellent communication and collaboration skills with the ability to effectively work across internal and external teams
• Proficiency with CTMS, eTMF systems, and Microsoft Office applications
• Ability to thrive in a fast-paced, evolving biotech environment with a proactive and solutions-oriented mindset

Required Knowledge, Skills, Abilities & Behaviors

• Highly organized with strong attention to detail
• Strong follow-up, tracking and documentation skills
• Ability to manage multiple priorities and timelines
• Clear and professional communication style
• Comfortable working cross-functionally with internal teams and external partners
• Proactive, resourceful and willing to roll up sleeves
• Strong judgment around escalation, urgency and quality
• Ability to work independently while staying closely connected to team priorities
• Strong Communication and Stakeholder Management skills
• Process Improvement and Strategic Thinking
• Risk identification and management

Work Environment

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.

This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee’s manager. Business travel may be required depending upon the specific needs of the position.

The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.

Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.