Radionetics Oncology
Clinical Scientist (Director/Senior Director)(hybrid)
Radionetics Oncology, San Diego, California, United States, 92189
About Radionetics
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 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. 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 ongoing 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 cross-functional partners within and outside 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, CRFs, 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.Travel domestically and internationally, up to 25%, as required.Perform other responsibilities as required by business needs.
Minimum Required Qualifications
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 an 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 functions 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.
Pay Range:
$208,000 - $234,000 (Director range); $250,000 - $300,000 (Sr. Director range).
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.
Important Notices
Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class.
The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time.#J-18808-Ljbffr
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 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. 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 ongoing 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 cross-functional partners within and outside 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, CRFs, 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.Travel domestically and internationally, up to 25%, as required.Perform other responsibilities as required by business needs.
Minimum Required Qualifications
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 an 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 functions 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.
Pay Range:
$208,000 - $234,000 (Director range); $250,000 - $300,000 (Sr. Director range).
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.
Important Notices
Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class.
The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time.#J-18808-Ljbffr