The Senior Director, Clinical Scientist, Oncology will lead the scientific planning and execution of clinical trials for our oncology assets including development of clinical trial designs and data interpretation. This role involves strategic oversight and hands-on management of clinical studies ensuring alignment with regulatory requirements and corporate objectives. This leader will play a critical role in the design, execution, and interpretation of clinical trials for our oncology drug candidates.
The role is preferentially based in NJ or remotely from the East Coast and will report to the SVP, Clinical Development and Medical Affairs.
Responsibilities
Leadership
Serve as the lead clinical scientist on clinical trials, providing scientific and strategic direction.
Clinical Trial Management
Oversee the design, conduct, analysis, and reporting of clinical trials in accordance with GCP and ICH guidelines.
Perform site-facing activities such as training and responding to clinical inquiries.
Review development of site and CRA training materials and presentation at Site Initiation Visits and Investigator meetings and support on Study committee (e.g., Safety Review Committee) activities.
Conduct activities related to data generation and validation, and clinical data review/query resolution.
Collaboration
Work closely with cross-functional teams, including Medical Affairs, Clinical Operations, Regulatory Affairs, and Research, to ensure the successful progression of our clinical programs.
Collaborate with principal investigators, key opinion leaders, and clinical trial sites to ensure robust study design and execution.
Data Analysis
Lead the monitoring team in the review and interpretation of clinical data and protocol deviations.
Contribute to the preparation of clinical study reports, regulatory submissions, and publications.
Present clinical trial data and findings to internal and external stakeholders, including scientific advisory boards and regulatory agencies.
Reviews competitive landscape and supports the identification of business development opportunities.
Regulatory Compliance
Ensure clinical trial data integrity and adherence to regulatory requirements and support the preparation of regulatory submissions.
Help develop program strategy including the clinical development plan and related timelines, product lifecycle plans, target product profiles and draft labels.
Qualifications
MD, PhD, PharmD, MS, or equivalent degree in life sciences required
Minimum of 8 years of experience in clinical science, clinical research, or equivalent, with required experience in Oncology.
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols.
Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., GCP, ICH, FDA).
Experience working in a matrix management and cross-functional team environment.
Ability to interact externally and internally to support scientific and business strategy.
Excellent analytical and organizational skills.
Must possess excellent oral and written communication and presentation skills.
Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.