Sr. Director, Trials

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function):

The Sr. Director, Company Sponsored Trials (CSTs), Med Ops & Program Management reports to the Head of USMA Oncology Medical Operations & Program Management. They will lead a team Center of Excellence focused on delivery of Incyte-supported medical affairs research with quality, scientific rigor, consistency with strategy, and delivery on time, on budget, and according to all applicable policies, SOPs, and best practices.

Their work will focus on Incyte-sponsored studies but may span a broad spectrum of interventional and observational studies, real-world-evidence and Health Economics and Outcomes research, collaborative research, and investigator-initiated research. They do this directly through individual contribution and through direct management of others, who may be contractors or Incyte employees. In addition, they will collaborate with others on the Ops and Program Management team to ensure USMA goals and deliverables are successfully completed, and to help with oversight and continuous improvement of USMA activities, processes, and systems.

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.

Oversight of Incyte sponsored research:

* 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.

* Collaborate seamlessly with the MA home office team, field teams, cross-departmental colleagues/stakeholders and external consultants/vendor (agency) representatives to ensure timely, quality execution of activities and projects.

* 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…