Director/Senior Director, Clinical Scientist

Radionetics Oncology; San Diego (CA); On-site; USD 208,000 - 280,000; Full time

Job summary

A leading radiopharmaceutical company is seeking a Director/Senior Director, Clinical Scientist in San Diego. This key role involves managing clinical trials and collaborating with stakeholders to ensure adherence to protocols. Candidates should have a strong background in clinical research, excellent strategic planning skills, and a commitment to high-quality data delivery.

Benefits

Equity

401(k) retirement plan

Paid time off (4 weeks annually)

Comprehensive medical, dental, and vision insurance

Qualifications

• Minimum 10-12 years of experience in clinical research.
• Experience in pharmaceutical or biotech industries preferred.
• Solid understanding of ICH GCP and FDA regulations.

Responsibilities

• Lead clinical trial planning and execution.
• Analyze and interpret clinical data.
• Develop training for CROs and trial sites.

Skills

Collaboration

Data Analysis

Regulatory Knowledge

Project Management

Education

Advanced degree in life sciences/healthcare

Job description

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 https://radionetics.com.

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
  
  

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 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
  
  

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 - $240,000 (director range); $250,000 - $280,000 (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.

Radionetics does not accept unsolicited referrals from employment agencies for position vacancies unless written authorization is provided from the Human Resources department before any candidates are referred for specific identified positions. In the absence of such written authorization, any actions taken by the employment business/agency shall be deemed to have been performed without consent or contractual agreement, and Radionetics shall not be liable for any fees arising from such actions or referrals for position vacancies at Radionetics.

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