Our success is rooted in our exceptional team, and we are always looking for passionate, talented individuals to join us. We believe in sharing our success with everyone who contributes, which is why we grant stock options to every employee.
We are building a first-class team in the US. Our team shares the desire to deliver hope to cancer patients worldwide. We offer a flexible hybrid and remote structure and excellent health and financial benefits. Explore our job openings below.
• Lead the end-to-end operational management of assigned clinical trials, ensuring timely initiation, enrollment, execution, and close-out.
• Act as the primary clinical operations lead on cross-functional study teams.
• Support clinical development strategy by providing input on study design, site selection, and operational feasibility.
• Own and manage clinical trial budgets, including initial budget development, forecasting, accruals, and variance analysis.
• Lead contract and budget negotiations with CROs, vendors, and clinical sites.
• Review and approve vendor contracts, scopes of work, change orders, and payment terms in partnership with Finance.
• Monitor financial performance to ensure alignment with overall program goals and OnCusp’s operational strategy.
• Manage CROs and third-party vendors to ensure quality execution and compliance with timelines and deliverables.
• Define and track key performance indicators (KPIs) to assess vendor performance.
• Provide proactive oversight and issue resolution across vendor relationships.
• Support and mentor clinical operations team members and contribute to building a highperforming Clinical Operations function.
• Contribute to the development, implementation, and refinement of Clinical Operations SOPs and best practices.
• Support inspection readiness and quality compliance through risk-based monitoring and internal audit support.
• Partner with Clinical Development, Clinical Science, Regulatory, Translational, and Project Management to align operational execution with strategic goals.
• Contribute to the development of key study documents (protocols, informed consents, monitoring plans, trial master files, etc.).
• Ensure timely and quality data delivery and collaborate on clinical data review and database lock processes.
• Maintain strong relationships with clinical sites and investigators to ensure proactive engagement and recruitment support.
• Participate in clinical site feasibility, selection, and activation activities.
• Support communications with KOLs, regulatory authorities, and external partners as needed.
• Bachelor's degree in a life sciences field required; advanced degree (MS, MPH, PharmD, or equivalent) preferred.
• 10+ years of experience in clinical operations, with at least 5 years in oncology trials and global program execution.
• Demonstrated experience in clinical trial budgeting, financial tracking, and contract negotiations.
• Strong knowledge of ICH GCP, FDA, and EMA regulations.
• Operates with urgency, ownership, and accountability.
• Comfortable in a lean, high-growth biotech setting where strategic thinking is balanced with hands-on execution.
• Flexible and adaptive; able to pivot and problem-solve in real-time.
• Proven ability to manage and lead in a cross-functional, matrixed environment.
• Hands-on experience with allphasees (FIH/Phase I-IV) clinical trials preferred.
• Excellent organizational, interpersonal, and communication skills.
• Ability to travel domestically and internationally as needed.
• Provide daily executive support to the CDO and CMO, including managing complex calendars, scheduling internal and external meetings, and anticipating logistical needs
• Coordinate domestic and international travel and conference attendance, including detailed itineraries and expense reporting
• Organize monthly team in-person meetings including setting agendas, securing meeting space, planning meals/catering, supporting travel & accommodations, and ensure all logistics run smoothly
• Ensure CDO and CMO’s expense reimbursements are completed in an accurate and timely manner
• Manage team meetings (coordinate schedules, agendas, notes, and follow-ups as needed) and all external meetings as requested by the CDO, CMO, and R&D team
• Serve as the point of contact for facilities and administrative services; oversee office supply procurement and inventory
• Process, track, and file vendor and Key Opinion Leader (KOL) contracts; ensure alignment with internal workflows and deadlines
• Collaborate closely with Corporate Finance to create and manage purchase orders (POs)
• Lead or support special projects as assigned; manage timelines, coordinate stakeholders, and drive deliverables
• Bachelor’s degree required
• Minimum 3 years of experience supporting senior executives in a high-paced, dynamic environment
• Proven ability to prioritize effectively, manage multiple tasks, and work independently
• High proficiency with Microsoft Office Suite and ability to quickly learn new software/tools
• Outstanding written and verbal communication skills
• Demonstrated success in roles requiring confidentiality, initiative, and judgment
• Flexible schedule to support international teams (China time zone and Pacific time zone alignment as needed)
• Tri-State Area-based preferred; NYC office attendance monthly
• Experience in life sciences, biotech, or pharma preferred, especially in small or mid-sized organizations
• Serve as a scientific lead and be accountable for the clinical execution of clinical study protocols including providing clinical oversight and medical review of clinical trial data
• Respond to study questions from CROs and sites, with study medical monitor supervision where needed
• Contribute and coordinate the writing and revision of clinical documents, such as study protocols, protocol amendments, clinical study reports, investigator brochures, and other materials for regulatory submission
• In collaboration with medical writing and other functions, work on clinical study protocol(s), amendments, study manuals/plans, and other study materials
• Assists in drafting clinical scientific documents such as IND, IND amendments, investigator brochures, annual DSUR and FDA or other regulatory submissions
• In collaboration with data management contribute to case report form development and completion guidelines
• Monitor, review, and summarize safety and efficacy data in 1 or more ongoing studies.
• Represent clinical development at project team meetings internally, CRO/vendors, and partners
• Develop and manage relationships with appropriate consultants
• Contribute to the planning and design of new clinical studies, in addition to contributing to the creation and updating of CDPs in accordance with corporate objectives
• Work in close collaboration with Clinical Operations to ensure translation of the clinical protocol (and amendments) into operational deliverables, including but not limited to performing ongoing review and analysis of clinical study data and preparing/reviewing study plans (i.e., Medical Monitoring, Medical Data Review, Safety Management, etc.)
• Establish good working relationships with external scientific advisors, thought leaders, clinical investigators, and external partners
• Perform literature searches and critically review and summarize the relevant scientific, drug development, and medical literature to support new clinical trial design as well as the development of clinical and/or regulatory documents
• Support preparation of scientific material for conference presentations or publications
• Contribute to the development of SOPs and associated guidelines and templates
• Ph.D. or PharmD preferred, minimum 6 years of biopharmaceutical experience working on oncology clinical studies
• BS or MS degree with 10+ years of biopharmaceutical experience working on oncology clinical studies
• Experience in small or mid-sized biotech companies
• Experience in Oncology and first-in-human Phase I studies required; Phase 3 and NDA/ BLA experience strongly preferred.
• Experience working with medical monitors, R&D functions, regulatory affairs, program management, quality assurance, thought leaders, and clinical investigators
• Excellent communication (oral and written), analytical, organizational, and project management skills
• Ability to think strategically and creatively, function independently, deliver on timelines, have strategic insights, and have a detailed knowledge of the activities, and procedures involved in clinical drug development
• Strong ability to work collaboratively in a matrix environment and to foster relationships.
• Experience with global clinical studies
• Experience with critical regulatory submissions
