Job Summary (Primary function)
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 or equivalent experience
- 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 verbal 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 dynamic environment
- Knowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelines
- Experience in managing team members is 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 challenging business situations
- Ability to accommodate up to 20% travel or as business dictates
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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