Senior / Principal Clinical Scientist, Clinical Development

Position Overview

We are seeking a highly motivated and experienced Clinical Scientist to join our team. The Senior / Principal Clinical Scientist, Clinical Development 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. 

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. 

• Travel may be required. 

Knowledge and 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. 

 WA State Range: Senior Clinical Scientist, Clinical Development - $145,823 - $182,019 

WA State Range: Principal Clinical Scientist, Clinical Development - $169,883 - $200,742