Radionetics Oncology, Inc. is a clinical stage company focused on the discovery and development of novel radiopharmaceuticals for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics. Radionetics Oncology is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments and has entered into a strategic agreement with Eli Lilly. Radionetics is advancing a pipeline of first-in-class small molecule radioligands targeting G protein coupled receptors for the treatment of a broad range of cancers, including breast cancer, lung cancer, and other indications of high unmet need.
Position Summary
The Clinical Trial Manager/Senior Manager, Clinical Operations acts as the main point of accountability for assigned projects and reports directly to the Director of Clinical Operations to ensure the integrity and success of Radionetics Oncology’s clinical trials. This position is a key cross-functional team member contributing to the design and execution of the company’s clinical trials and is responsible and accountable for ensuring there is an alignment of Clinical Operation timelines and deliverables with organizational objectives. The position provides strategic and operational leadership to ensure milestones are delivered on time, within budget, with high quality, and in compliance with all applicable regulations, guidelines, and SOPs.
Essential Job Functions And Duties
Lead clinical operation activities in assigned projects to expedite the execution of clinical trials with the highest level of regulatory, ethical, and safety standards.
Participate and support the design, implementation, and review of clinical protocols and study reports for scientific and operational accuracy in assigned projects.
Ensure all assigned programs are appropriately resourced with staff who have appropriate qualifications and current training.
Ensure departmental processes and SOPs are adequate to ensure consistent, efficient, and high-quality execution of clinical studies; establish new processes as required.
Establish excellent communication and collaboration with the cross-functional partners within the company and outside of the company.
Provide consistent, detailed, and accurate clinical study timelines and deliverables; work closely with Director of Clinical Operations to establish cross-functional corporate timelines and objectives.
Deliver timely, high-quality clinical study data, working in concert with external and internal partners.
Identify, recruit, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators to prioritize enrollment and ensure timely and high-quality execution of clinical studies.
Lead and support the selection, contracting, and oversight of CROs and vendors in assigned projects.
Assist with strategic planning and development of the operational model for each assigned study, including site and country selection; develop and maintain study startup and enrollment forecasts; closely monitor projections vs, actuals.
Work closely with clinical department team members and other stakeholders to develop and drive patient accrual strategy to meet appropriate corporate timelines.
In assigned projects, lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, oversee IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRF’s, DMP edit checks, safety plan, Safety Management Team and DMC charter, close-out plans, inspection readiness plans, and CSRs.
Assist with the development of study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring Committees.
Assist in writing publications and scientific presentations.
Provide operational expertise to internal and external teams (CMC, regulatory affairs, non-clinical, medical writing, data sciences, drug safety, CROs, consultants) to ensure that Clinical Development scientific and medical strategies are met.
Collaborate with Finance to develop and effectively manage annual budget for clinical activities and budget forecasting for assigned projects.
Review contracts and work closely with Legal to ensure execution of contracts per company requirements and to planned timelines.
Deliver regular presentations at senior management meetings providing up to date clinical operation metrics.
Travel domestically and internationally, up to 25%, as required.
Perform other responsibilities as required based on business needs.
Minimum required qualifications
Bachelor’s Degree in health care or other scientifically related discipline is required. An advanced degree (e.g., Masters, MBA, RN, NP, PA) is a plus.
Minimum 5 years of experience in clinical operations (Clinical Trial Manager) with a proven track record of project management; working knowledge of details and issues involved in cross-functional areas.
Experience in a scientific discipline with clinical drug development experience and strategic planning specifically in the pharmaceutical or biotech industries is preferred; however, other relevant experiences and skills may be considered.
Experience in oncology is preferred, radiopharmaceutical experience is a plus.
Highly motivated and thrives working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
Self-starter who can lead and manage function independently, while utilizing sound judgment.
Non-standard work schedule, travel or environmental requirements
The position is based in San Diego, CA; a portion of the job duties may be performed remotely.
Domestic and international travel may be required up to 25%.
Compensation & Benefits
Radionetics has a competitive total compensation package that includes bonus opportunity; equity; medical, dental, vision, life, short-term, and long-term disability insurance; 401(k) retirement plan; 4 weeks of paid time off (PTO) annually; and generous paid holidays.
Radionetics evaluates a variety of factors in determining individual pay decisions, which may include relevant education, experience, and skills; internal equity; complexity and responsibility of the role; and market demand relative to the position. Geographic location may also be a consideration in evaluating salary when candidates work in states outside of California.
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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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