Director/Senior Director Clinical Research Scientist

This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs. This hire will report directly to the CMO. **Essential Functions of the Job (Key responsibilities)** - Design and author protocols and protocol amendments for clinical studies - Responsible for providing clinical input into eCRF design, SAP, and TLFs - Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends - Provide clinical updates on assigned compounds/programs to Sr. management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees - Lead or co-lead the ICF risk language across a compound to ensure a consistent approach - Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans - Lead, co-lead, and contribute to the review of clinical sections of documents such as IND, IND amendments, Investigator Brochures, oncology unique CRFs, Annual Reports and other Health Authority submissions - Manage relevant issue escalation to resolution, as items arise on Clinical Development Programs - Coordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of content - Attend and present at various meetings with internal and external stakeholders (e.g., investigator meetings, scientific advisory boards, etc.) - Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategy - Clinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compounds - Maintain updated knowledge of competitive landscape of assets with similar MOA and/or evolving standards of care for indications of interest - Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed - Liaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicable - Consult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgets