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Senior Clinical Research Scientist
2 months ago
About Radionetics Oncology
Radionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of groundbreaking radiopharmaceuticals aimed at treating a diverse array of oncology conditions. With robust backing from esteemed investors and strategic partnerships, Radionetics is at the forefront of developing first-in-class small molecule radioligands targeting G protein coupled receptors, addressing significant unmet medical needs in various cancers, including breast and lung cancer.
Role Summary
The Director/Senior Director, Clinical Scientist will report directly to the Chief Medical Officer, overseeing the planning, execution, and management of clinical research initiatives. This role necessitates collaboration with both internal teams and external partners to ensure the integrity and success of clinical trials. The Clinical Scientist will provide strategic insights and developmental support for clinical plans, assess and interpret clinical data, review and draft study-related documentation, and deliver training related to protocols to CROs and clinical trial sites.
Key Responsibilities
- Contribute to the formulation of the clinical development strategy in collaboration with cross-functional teams, KOLs, and CROs.
- Draft, manage, and review study documentation for regulatory submissions, leveraging insights from clinical and scientific experts.
- Analyze and interpret data from clinical trials, working closely with clinical operations for comprehensive data review.
- Resolve conflicts internally and externally to maintain trial integrity and success.
- Design and deliver protocol training sessions for CROs and trial sites.
- Maintain ongoing engagement with trial sites and CROs to monitor patient data and ensure adherence to protocols.
- Stay informed on the therapeutic landscape, current medical practices, and pharmaceutical regulations to uphold best practices.
- Foster effective communication and collaboration with cross-functional partners.
- Ensure timely delivery of high-quality clinical study data in collaboration with external and internal stakeholders.
- Assist in the identification, recruitment, and management of clinical trial sites, ensuring timely execution of studies.
- Support clinical operations in the selection and oversight of CROs and vendors for assigned projects.
- Collaborate with clinical teams to develop strategies for patient accrual in alignment with corporate timelines.
- Lead or assist in the creation and review of clinical project deliverables, including regulatory documents and study protocols.
- Oversee the development of study presentations and coordination of Investigator Meetings and Advisory Boards.
- Contribute to the writing of scientific publications and presentations.
- Willingness to travel domestically and internationally as required.
- Perform additional responsibilities as dictated by business needs.
Qualifications
- Advanced degree in life sciences or a clinically relevant field is required; advanced degrees such as Master's, PharmD, MPharm, PhD, MBBS, BDS, or MD are strongly preferred.
- A minimum of 10 years of experience for Director level or 12 years for Senior Director level, with at least 5 years in a Clinical Scientist or similar role.
- Comprehensive understanding of the setup, organization, and execution of global clinical studies within a pharmaceutical company or CRO.
- Experience in clinical drug development and strategic planning within the pharmaceutical or biotech sectors is preferred; other relevant experiences may be considered.
- Oncology experience is preferred; familiarity with radiopharmaceuticals is a plus.
- Demonstrated ability to thrive in a fast-paced, innovative environment while being flexible and resourceful.
- Strong knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
- Self-motivated with the ability to lead and manage functions independently.
Work Environment
This position may allow for a portion of responsibilities to be performed remotely, with potential travel requirements of up to 25%.
Compensation & Benefits
Radionetics offers a competitive compensation package that includes bonus opportunities, equity, comprehensive insurance coverage, a 401(k) retirement plan, and generous paid time off.
Equal Opportunity Statement
Radionetics Oncology, Inc. is committed to equal opportunity employment practices, ensuring that all qualified applicants receive equal consideration without regard to protected characteristics.
