Our client is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Their portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies.
Position Overview
We are seeking a highly experienced Director/Associate Director, Clinical Scientist to join their team. The Director/Associate Director, 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
- 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
- Ensure clinical trial data integrity and adherence to regulatory requirements.
- 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 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.
- May provide mentorship to other team members.
- Travel may be required
Qualifications
- PhD, MD, PharmD, MS, or equivalent degree in life sciences
- Minimum of 5 years of experience in clinical science, clinical research, or equivalent; preferably in oncology.
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.