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. 

Cartography Biosciences is seeking an experienced hands-on Senior Clinical Trial Manager (Sr. CTM) to join our growing team and lead the execution of early-phase oncology clinical trials. The Sr. CTM will be responsible for the operational oversight of one or more studies, including vendor and site management, budget oversight, and ensuring trials are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. This individual will play a critical role in driving high-quality, timely, and cost-effective delivery of our clinical programs in a fast-paced, collaborative biotech environment.

Roles and Responsibilities:

• Collaborate with cross-functional teams to establish project objectives, study protocols, timelines, and budgets. Oversee the operational execution of clinical studies from the initial synopsis through final deliverables, ensuring quality, compliance, and a hands-on approach to day-to-day operations.
• Drive assessment, selection, engagement, management, and oversight of appropriate vendors.
• Serve as primary operational contact for CROs, vendors, and clinical sites. Provide proactive and consistent oversight of CRO and vendor performance and ensure delivery to agreed quality and timelines.
• Lead site feasibility, selection, and initiation activities in collaboration with internal and external partners. Foster strong relationships with investigators and site staff.
• Play an active role in day-to-day operations to ensure effective trial execution, ensuring all team members are supported and guided appropriately.
• Ensure adherence to Good Clinical Practice (GCP) and regulatory guidelines. Prepare and submit necessary documentation to regulatory authorities.
• Develop, review, and collaborate on key trial documents (protocols, informed consent forms, study manuals, monitoring plans, etc.).
• Oversee data collection processes and ensure data accuracy. Monitor study progress and data quality, escalating risks and proposing mitigation strategies. Work closely with the Data Management and Clinical Science team to address discrepancies, providing a hands-on approach to ensure data integrity throughout the study lifecycle and to develop the data cleaning strategy for the study.
• Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary.
• Conduct regular oversight visits, actively monitoring study progress, compliance, and quality. Provide real-time updates to stakeholders on study status, key metrics, and challenges, ensuring no detail is overlooked.
• Manage study budgets, including forecasting, tracking expenses, and ensuring timely payments to vendors and sites. Take an active role in overseeing resource allocation and vendor selection, ensuring financial and operational efficiency.
• Lead, mentor, and manage clinical trial teams, fostering a hands-on, collaborative, and productive work environment. Ensure effective communication and coordination among cross-functional team members to drive successful trial outcomes.
• Identify and mitigate risks early, prioritizing tasks to ensure the successful accomplishment of study objectives. Provide leadership and oversight in resolving any issues that arise during the course of the study.
• Effectively track and communicate program and study progress to Senior Management, utilizing detailed dashboards and trackers. Be actively involved in the preparation of reports and meetings, ensuring transparency and proactive communication.
• Stay informed of changes in regulations, guidance, and the competitive landscape, assessing their impact on clinical projects. Adjust operational strategies and protocols as necessary, ensuring projects remain aligned with regulatory expectations.

Qualifications:

• Bachelor’s degree with 6+ years of pharmaceutical or biotech-related/clinical research, research experience
• Proven track record of managing multiple studies and delivering results on time and within budget.
• Experience in high-level trial management with a strong cross-functional approach, coupled with a people-oriented mindset and a positive attitude, is highly desirable.
• Must have extensive experience in managing Phase 1 and Phase 2 clinical trials, specifically in oncology, with a demonstrated ability to manage complex studies from start to finish.
• Prior experience with First-in-Human clinical studies, particularly those involving complex protocols, is highly desirable.
• Experience in immuno-oncology research is beneficial.
• In-depth knowledge of T-Cell Engager (TCE) or CAR-T methodologies, and regulatory considerations. Experience managing trials involving TCEs or CAR-Ts is highly preferred.
• Exceptional organizational and project management skills, with the ability to manage multiple tasks and stakeholders while meeting tight deadlines.
• Strong knowledge of ICH-GCP, FDA regulations, and other relevant guidelines.
• Excellent communication, organizational, and leadership skills.
• Proficiency in clinical trial management software and data management systems.
• Ability to anticipate and resolve issues proactively, ensuring successful trial execution and delivery.
• Ability to thrive in a small, fast-paced, and evolving biotech environment.
• Willingness to travel (up to ~20%).

What We Offer:

• Opportunity to be a key contributor in shaping an innovative early-phase oncology pipeline.
• A dynamic, collaborative, and mission-driven culture.
• Competitive compensation, equity, and comprehensive benefits.