Job Summary (Primary function):
Essential Functions of the Job (Key responsibilities):
Directly and through mentoring, training, and supervising others, lead the following activities:
Operational support of research activities:
Work with Head of Medical Operations and Program Management and rest of USMA team to ensure appropriate conduct and support of research, according to all appropriate Incyte policies, SOPs, work instructions, and best practices as applicable.
Maintain current and effective training matrix of SOPs and Work Instructions for USMA personnel.
Support training and management personnel in identifying opportunities for training in research skills, tools, and processes. Help create and perform training as assigned.
Ensure medical affairs currency and consistency with R&D process updates.
With appropriate collaboration and stakeholder management, leverage operational expertise to map and adapt R&D processes, and/or creation of medical affairs processes, where the R&D methods are not optimal for the medical affairs research setting.
Perform / oversee Incyte appropriate CRO and vendor management/oversight.
Perform / oversee study startup, execution, maintenance and close-out activities within projected budget, timelines and in accordance with Incyte SOPs.
Independent Investigator Initiated Research (IIR) Programs as assigned:
Partner with IIR team members to help ensure appropriate concept and protocol reviews and study execution, maintenance and close-out activities within projected budget, timelines and in accordance with Incyte policies, SOPs, and work instructions.
Support of Project Management (PM) as assigned:
Assist Head of Med Ops and Program Mgmt. and PM colleagues in development of plans and objectives
Monitor deliverables as assigned, including identification, escalation, and mitigation of issues
Assist in development and review of relevant project timelines, priorities, metrics
Serve as member of USMA Leadership Team (USMALT). In addition to oversight role tracking execution across projects, serve as senior leader and provide advice based on core expertise, e.g., on operational feasibility, best practices, and resourcing.
Support cross-functional communication among the MA functional teams through appropriate methods.
Ensure MA team plans and activities within purview are integrated into higher level planning documents and calendars.
Support of Medical Operations and Analytics assigned:
Assist Operations and Analytics colleagues in developing and monitoring metrics, tools, and reports to understand KPIs and trends in deliverables within purview
Assist with process improvements and development/maintenance of SOPs
Support optimal use of tools, systems, and processes
Qualifications:
Bachelor’s degree required, advanced degree preferred
Significant relevant experience required
Demonstrated expertise with clinical trial operationalization in the biopharma setting, including adherence to Good Clinical Practice, policies and SOPs, and use of tools and processes (MS Office, clinical trials conduct and reporting systems).
Clinical Development study operations experience preferred. Prior Medical Affairs experience preferred but not required. Interest and ability to understand operating principles of various functions in a Med Affairs org, as well as successful medical support of brand-related projects and initiatives.
Interest in innovation and ability to lead and implement change through influence management and tenacity.
Dependable self-starter, capable of working independently on multiple projects. Excellent organization skills, ability to respond to tight and urgent timelines and to solve problems, including knowing when to escalate and how to manage stakeholders.
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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