About Cartography Biosciences

Cartography Biosciences is a therapeutics organization creating the first atlas to identify targets that are specific enough to only engage cancerous cells, broad enough to work across cancer cells and patients, and safe enough to sidestep toxic side effects. Founded by Kevin Parker, Howard Chang, and Ansu Satpathy, Cartography is bridging immunology and computation to understand the critical differences between normal and cancerous cells, ultimately solving the challenge of finding the safest, most selective targets for a variety of immunotherapeutic approaches.

The Clinical Trial Specialist (CTS) supports the execution and oversight of early-phase (Phase 1/First-in-Human) oncology clinical trials. This role is critical in ensuring safe, compliant, and efficient trial conduct in complex early development settings, including dose escalation, expansion cohorts, intensive safety monitoring, and rapid data review cycles.

The CTS partners closely with Clinical Trial Managers, CROs, investigators, and cross-functional teams to drive study start-up, enrollment tracking, safety reporting coordination, and database readiness and will report to the Head of Clinical Operations. The ideal candidate thrives in a fast-paced biotech environment and is comfortable with change, tight timelines, and evolving protocols.

Key Responsibilities

• Support and oversee Phase 1 oncology trial activities including study start-up, site activation, dose escalation coordination, enrollment tracking, and investigational product tracking.
• Prepare, review, and maintain essential study documents including protocols, informed consent forms, Investigator Brochures, monitoring plans, pharmacy manuals, laboratory manuals, CRFs, and study charters.
• Partner with CROs and vendors to ensure transferred obligations, timelines, and quality expectations are clearly defined and met; escalate performance concerns when necessary.
• Track key operational metrics including screening, enrollment, dose-limiting toxicities (DLTs), serious adverse events (SAEs), biological samples, imaging, and protocol deviations.
• Support safety review processes including coordination of data for Safety Review Committees (SRCs) and dose-escalation decisions.
• May conduct UAT for EDC / IRT and data listing review of EDC data for analysis
• Assist with query resolution and data cleaning activities in preparation for interim analyses and database locks.
• Prepare study status reports, dashboards, and management updates for internal stakeholders.
• Respond to routine site inquiries in compliance with ICH-GCP and study protocol requirements.
• Draft site newsletters and study communications (FAQs, best practices, safety reminders).
• Participate in the development and continuous improvement of clinical SOPs and operational processes.
• May develop and provide training at investigator meetings, site initiation visits, and trial-specific teleconferences.

Qualifications

• Bachelor's or equivalent combination of education/experience, preferably in science or a health-related field
• At least 3 years of relevant experience, including experience working on multiple clinical studies and more than one phase of study

Knowledge/Skills

• Working knowledge of ICH-GCP and global regulatory requirements (FDA, EMA, MHRA).
• Experience supporting CRO-managed trials and cross-functional teams in biotech environments.
• Oncology clinical trial experience strongly preferred; experience with Phase 1 dose escalation trials is a plus.

Core Competencies

• Strong organizational and time management skills in fast-paced environments.
• Ability to manage multiple concurrent deliverables with minimal supervision.
• Clear and effective written and verbal communication skills.
• Strong attention to detail and analytical problem-solving abilities.
• Comfortable navigating evolving protocols and dynamic early-phase trial settings.
• Proactive risk identification and appropriate issue escalation.
• Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff)

Travel

Travel required up to 25%