Director of Clinical Research

1 week ago

San Diego, California, United States Radionetics Oncology, Inc. Full time
Position Overview

About Radionetics Oncology
Radionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at addressing a diverse array of oncology conditions. With strong backing from notable investors and strategic partnerships, Radionetics is committed to meeting the growing need for innovative radiotherapeutics.

Role Summary
The Director/Senior Director, Clinical Scientist plays a crucial role in the organization, reporting directly to the Chief Medical Officer. This position is responsible for the planning, execution, and oversight of clinical research initiatives in collaboration with both internal teams and external partners to ensure the integrity and success of clinical trials. The Clinical Scientist is instrumental in providing strategic insights and support for clinical development plans, analyzing clinical data, and ensuring compliance with regulatory standards.

Key Responsibilities

  • Collaborate with cross-functional teams and key opinion leaders to develop comprehensive clinical development strategies.
  • Draft, manage, and review essential study documentation for regulatory submissions, incorporating insights from clinical and scientific experts.
  • Conduct thorough analysis and interpretation of clinical trial data, working closely with clinical operations to facilitate data review.
  • Address and resolve conflicts to maintain the integrity and success of clinical trials.
  • Design and deliver training sessions for CROs and clinical trial sites regarding study protocols.
  • Engage continuously with trial sites and CROs to monitor patient data, ensuring adherence to protocols and data consistency.
  • Stay informed on therapeutic advancements, medical practices, and pharmaceutical regulations to uphold best practices.
  • Foster effective communication and collaboration with internal and external stakeholders.
  • Ensure timely delivery of high-quality clinical study data in partnership with external and internal teams.
  • Assist in the identification, recruitment, and management of clinical trial sites, collaborating with Principal Investigators to optimize enrollment and execution of studies.
  • Support clinical operations in the selection and oversight of CROs and vendors for assigned projects.
  • Work with clinical department members to develop strategies for patient accrual that align with corporate timelines.
  • Lead or assist in the preparation and approval of clinical project deliverables, including study protocols, safety plans, and monitoring tools.
  • Oversee the creation of study presentations and coordination of Investigator Meetings and Advisory Boards.
  • Contribute to the writing of scientific publications and presentations.
  • Travel may be required as part of the role.
  • Perform additional responsibilities as necessary to meet business needs.

Qualifications

  • Advanced degree in life sciences or a clinically relevant field is required; a Master's, PharmD, PhD, or MD is 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 role or similar.
  • Proven expertise in the setup and execution of global clinical studies within a pharmaceutical or CRO environment.
  • Experience in clinical drug development and strategic planning within the pharmaceutical or biotech sectors is highly desirable.
  • Oncology experience is preferred; familiarity with radiopharmaceuticals is an advantage.
  • Demonstrated ability to thrive in a fast-paced, innovative environment while being proactive and resourceful.
  • Comprehensive understanding of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
  • Self-motivated individual capable of leading and managing functions independently.

Work Environment
This position may allow for a hybrid work schedule, combining remote work with in-office responsibilities. Travel requirements may include both domestic and international trips.

Compensation & Benefits
Radionetics offers a competitive compensation package, including bonuses, equity options, and comprehensive health benefits, along with generous paid time off and holidays.

Equal Opportunity Employment
Radionetics Oncology, Inc. is committed to providing equal employment opportunities to all qualified applicants without regard to any protected status.

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