Principal/Senior, Clinical Scientist

Role Summary

We are seeking a highly motivated and experienced Clinical Scientist to join our team. The Principal/Senior, Clinical Scientist will play a critical role in the design, execution, and interpretation of multiple clinical trials for our oncology drug candidates. This individual will work closely with cross-functional teams, including clinical operations, regulatory affairs, and research and development, to ensure the successful progression of multiple clinical programs.

Responsibilities

• Oversee the execution of clinical trials and ensure scientific and regulatory rigor.
• Design and develop multiple clinical trial protocols, informed consent forms, and other study-related documents.
• Collaborate with principal investigators, key opinion leaders, and clinical trial sites to ensure robust study design and execution. Serve as Lead Clinical Scientist for multiple trials.
• Conduct activities related to data generation and validation, including CRF design and clinical data review/query resolution.
• Contribute to the preparation of clinical study reports, regulatory submissions, and publications.
• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.
• Perform site-facing activities such as training and responding to clinical questions.
• Participate in the strategic development of clinical development plans and timelines.
• Present clinical trial data and findings to internal and external stakeholders, including scientific advisory boards and regulatory agencies.
• Mentor and develop junior team members with potential to manage direct reports.
• Travel may be required.

Qualifications

• PhD, MD, PharmD, MS, or equivalent degree in life sciences.
• A minimum of 2 years of experience in clinical science, clinical research, or equivalent; clinical development experience is required, biopharmaceutical/biotechnology industry and oncology experience preferred.
• Strong leadership, project management, and communication skills.

Skills

• Extensive experience in drug development process, study design, clinical operations.
• Extensive experience in clinical trial data analysis software and tools.
• Strong knowledge and skills to support program specific data review, trend identification, and data interpretation.
• Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., GCP, ICH, FDA).
• Excellent analytical, organizational, and communication skills.
• Ability to work effectively in a fast-paced, collaborative environment.
• Strong problem-solving skills and attention to detail.

Education

• PhD, MD, PharmD, MS, or equivalent degree in life sciences.