Senior Director Clinical Scientist

Ph.D., MPhil or Pharm D., with 15 plus years of industry experience in clinical development.
Expert level knowledge of the therapeutic area (i.e., cell therapy, preferably in rheumatology or other immune mediated diseases).
Experience designing and driving industry-sponsored clinical trials.
Significant experience in the authoring of relevant regulatory documents.
Detailed understanding of the full drug development process.
Adaptive problem solving and learning and ability to navigate sophisticated organizations and systems.
Ability to influence both high level internal and external collaborators.
Ability to frame clear & succinct messages and simplify complexity of decision making.
Track record of leading high performing global cross-functional teams as well as line management experience.
Global awareness within the therapeutic area and global regulatory environment.
Expert level knowledge of the principles of clinical trial methodology, statistics, data analysis and interpretation.
Experience leading the development and implementation of cell therapy studies, including protocol and ICF development, electronic data capture database development, safety assessment, IB/DSUR submissions, and clinical data review. Authority in scientific literature searches and weighing of quality peer reviewed data.
Experience leading varying levels of internal/external management, Investigators and site personnel, clinicians, scientists, and cross-functional teams.

In collaboration with the Global Clinical program leads you will be accountable for the clinical program strategy, including innovative ways to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment and retention.
You will oversee planning, directing and delivering the operational components of assigned clinical programs from design concept to final CSR.
You are accountable for the medical & scientific support of studies, the development and implementation of immunology cell therapy sponsored clinical program strategy, externally sponsored collaborative research program strategy and studies, including clinical science support for initiating clinical trial(s).
You will lead a team of clinical scientists that provide expert scientific input, crucial in the preparation of regulatory documents and interactions with regulatory authorities.
You will also lead development of quality metrics and the data review plan for assigned studies, support and contribute to medical monitoring of trials, and ensure scientific input to TA standards.

Comprehensive knowledge of the multidisciplinary functions involved in a company’s cell therapy development process, e.g., research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, commercial operations.
Experience proactively integrating multiple perspectives into the clinical development process for the best end-result.
Experience in clinical development of CAR-T-cell therapy is highly desired.
Global external awareness within the therapeutic area and global regulatory environment.
Ability to travel nationally and internationally.