Job Details

About Radionetics
Radionetics Oncology, Inc. is a clinical stage radiopharmaceutical company focused on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics. Radionetics Oncology spun out of Crinetics Pharmaceuticals (Nasdaq: CRNX) and is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments. Radionetics is advancing a pipeline of novel small molecule radioligands targeting G-protein coupled receptors for the treatment of a broad range of cancers, including adrenocortical carcinoma, breast cancer, lung cancer, among others. For more information, visit

The Director/Senior Director, Clinical Scientist reports directly to the Chief Medical Officer and plans, implements, and manages assigned clinical research studies in collaboration with internal and external stakeholders to ensure trial integrity and success. The Clinical Scientist provides strategic input and development support for clinical plans, evaluating and interpreting clinical data reviewing and authoring study-related documents, monitoring patient data and data collection status, and delivering protocol-related training to CROs and clinical trial sites. The Clinical Scientist provides support for preparation of regulatory submissions necessary for the initiation of clinical studies. This position is a key cross-functional team member contributing to the design and execution of the company's clinical trials.

Essential job functions and duties

• Support the creation of the clinical development plan in partnership with cross- functional team members as well as KOLs and CROs.
• Author, manage, and review study materials for competent authorities' submissions; gain insights from clinical and scientific experts (e.g. protocol, regulatory documents, study report, safety review and communication).
• Analyze and interpret clinical trial data, collaborating with clinical operations to conduct data review.
• Troubleshoot internal and external conflicts to ensure trial integrity and success.
• Develop and present protocol training for CROs and trial sites.
• Engage with trial sites and CROs on an on-going basis to monitor subject data and data collection status, ensure adherence to protocol, and evaluate consistency of data.
• Maintain knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to help ensure best practices.
• Establish excellent communication and collaboration with the cross-functional partners within the company and outside of the company.
• Deliver timely, high-quality clinical study data, working in concert with external and internal partners.
• Collaborate with clinical operations to 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.
• Support clinical operations in the selection, contracting, and oversight of CROs and vendors in assigned projects.
• 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, 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.
• Lead the development of study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring boards.
• Lead in writing publications and scientific presentations.
• Perform other responsibilities as required by business needs.

• Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• Minimum 10 years (director) or 12 years (Senior director) of experience with 5+ years as a Clinical Scientist or comparable role.
• Solid knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution.
• 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.

• 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%.