This position will serve as a key scientific member of the Clinical Development team, providing scientific and operational contributions across one or more clinical studies.
The individual in this role will ensure the design, execution, and reporting of high-quality clinical trials through effective data review, document authorship, and cross-functional collaboration.
Success in this role requires substantial oncology experience, strong teamwork across clinical and scientific functions, and the ability to synthesize complex data into clear, actionable outputs that inform clinical decision-making.
[Key Responsibilities]
Study Execution and Scientific Oversight
- Contribute to the design, implementation, and reporting of early phase oncology trials.
- Lead authoring and review of clinical documents including study protocols, investigator brochures, clinical study reports (CSRs), and informed consent forms.
- Participate in medical data review, safety surveillance, and preparation of interim and final study analyses.
- Ensure consistency of scientific messaging across study documents, publications, and presentations.
Cross-Functional Collaboration
- Partner with Clinical Operations, Biostatistics, Regulatory Affairs, and Translational Science to ensure data quality and scientific integrity.
- Support preparation of regulatory submissions and responses
- Contribute to KOL engagement and investigator interactions as part of clinical team representation.
Data Interpretation and Communication
- Summarize and interpret emerging efficacy and safety data for internal meetings and external dissemination.
- Support preparation of abstracts, posters, and manuscripts for scientific conferences.
Functional Excellence
- Mentor junior team members and contribute to the continuous improvement of Clinical Science processes.
[Qualifications]
- PhD, PharmD, or MD in a life-science discipline strongly preferred; Master's degree with significant oncology development experience will be considered.
- 8-12+ years of clinical development experience in oncology within a biopharma or biotech setting.
- Hands-on experience with protocol development, data review, CSR preparation, and cross-functional study team participation.
- Familiarity with GCP, ICH, and global regulatory guidelines (FDA/EMA).
- Strong communication skills with ability to convey complex scientific concepts clearly.
- Proven ability to work effectively in a global, matrixed, fast-paced environment.