Sr. Clinical Trial Manager

Sr. Clinical Trial Manager

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems through protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $313M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

We are seeking an experienced, highly organized, and collaborative Senior Clinical Trial Manager (Sr. CTM) to join our Clinical Development Operations team. This is an ideal opportunity for a proactive clinical operations professional who enjoys working in a dynamic, fast-paced environment, takes ownership of outcomes, and is excited to help build scalable clinical operations processes.

Reporting to the Director of Clinical Operations, the Sr. CTM will manage key studies and/or clinical vendors, oversee critical trial deliverables, and ensure high-quality execution. The role will include broader responsibility for study management, operational strategy, and process development.

Key Responsibilities:

• Manage day-to-day operational execution of assigned phase 1-3 clinical studies and/or vendors to achieve study milestones, quality expectations, and budget objectives.
• Lead internal cross-functional study team activities and coordinate operational deliverables across internal stakeholders and external vendors.
• Oversee assigned CROs and study vendors to ensure timely delivery, issue resolution, quality performance, and compliance with study requirements.
• Support study start-up activities including feasibility assessments, country and site selection, vendor selection, system set-up, and user acceptance testing.
• Develop and maintain study presentations, dashboards, reports and study tracking tools to support effective trial execution and to communicate study progress, operational metrics, risk and key decisions to cross functional teams, leadership and external partners.
• Ensure inspection readiness and maintain Trial Master File documentation in compliance with ICH/GCP guidelines and company SOPs.
• Monitor study progress, identify operational risks, and implement mitigation plans to address issues impacting quality, timelines, or budget.
• Contribute to data review, data cleaning activities, and operational review of study outputs and clinical study documentation.
• Review study invoices, support accrual tracking activities, and monitor study spend against approved budgets.
• Manage the development of and cross-functional review of study documents (ICFs, contracts, budgets), study plans/processes, and SOPs.
• Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics and timelines, and critical study activities.

Knowledge and Skills Requirements:

• BS/BA or equivalent degree.
• Minimum of 8 years of relevant experience in either sponsor or CRO (at least 3 years clinical trial management experience).
• At least 3 years of clinical trial experience in Oncology required.
• Strong track record for successful study initiation and execution.
• Experience leading global, multicenter Ph3 clinical trials.
• Advanced knowledge of study management best practices and tools, with demonstrated ability to improve study efficiency and effectiveness.
• Working knowledge of policies and procedures that govern clinical research, including but not limited to FDA, EMA and other applicable national regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA).
• Experience managing CROs and third-party vendors.
• Experience leading teams and mentoring less experienced colleagues.
• Experience in Finance Management (Budget forecasting, review of SOW, invoices and accruals).
• Experience working with EDC, CTMS, and eTMF systems.
• Self-motivated and able to thrive in a fast-paced, start-up environment.
• Skilled in communicating effectively, both written and verbal.
• Must have exceptional leadership skills, including motivation and delegation.
• Ability to establish and maintain effective and productive working relationships with all employees, in a variety of organizations.
• Exceptional customer service and people skills.
• Attention to detail.
• Ability to work independently within a defined strategy.

The anticipated salary range for the position of Senior Clinical Trial Manager based in our Menlo Park, CA office is $175,000-189,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state federal and local laws regarding pay practices.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).