Description:
This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs as assigned by phase or therapeutic area.
Essential Functions of the Job (Key responsibilities)
- Design and author protocols 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, eDMC 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
- Maintain alignment with the asset Global Lead, Operational Asset Lead, and Global Product Strategy Lead
- 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 (eg, 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
- Contribute or lead process improvement initiatives
- Provide mentoring, leadership, guidance, and clinical science expertise to Incyte personnel to enable proper decision-making
- Maintain updated knowledge of competitive landscape in regards to 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
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Degree in scientific/life-sciences field such as Master’s, Pharm.D, or Ph.D/EdD degree preferred
- Minimum of 10 years of experience in research with at least 6 years of drug development experience are required. Alternative drug development experience will be considered.
- Prior Oncology Drug Development experience required
- Global oncology trial experience and Health Authority experience are highly preferred
- Excellent written and oral communication skills
- Strong analytical and strategic ability
- Ability to work independently and to multi-task large projects or compounds, ability to change pace and tasks as needed, and to work in a fast-paced environment
- Knowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelines
- Ability to manage direct reports a plus
- Ability to lead and/or be a proven leader in a line function responsibility, as well as having an ability to influence in a matrix global environment
- Have proven ability to drive decisions and manage in difficult business situations
- Ability to accommodate up to 20% travel or as business dictates