Director/Senior Director, Medical Operations & Program Management

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

The Director, Medical Operations & Program Management plays an integral role within US Medical Affairs organization. This position will be responsible for executing strategy and ensuring operational excellence. The focus of this role will include leadership in medical affairs program and operational management. The Director is also responsible for driving the annual business planning, management of the department budget, project timelines and priorities. This role will require an ability to work and think independently as well as interact with various cross-functional areas and organizational levels.

Essential Functions of the Job (Key responsibilities)

The Director is responsible for leading initiatives on the Medical Operations & Program Management team which includes the key responsibilities:

* Trains, supervises, and mentors direct reports in all operational aspects of their position.

* Coordinates project management efforts across the team, specifically by integrating Medical Affairs project deliverables and timelines to the needs of the department.

* Represents Medical Affairs in various cross-functional working groups.

* Coordinates the yearly USMA departmental budget development and routinely monitors department spend throughout the year.

* Contributes towards the development of departmental goals and participates in strategic and operational planning.

* Ensures USMA key priority projects and program activities are incorporated into monthly dashboards and quarterly goal progress updates.

The Director is also responsible for serving as the operational lead for the following USMA programs:

* Company-Sponsored Study Management (i.e., Phase 4, Observational, Expanded Access programs):

o Assists in the review, development and/or writing of study documents and manuals; including but not limited to protocols, study start-up plans and informed consent forms.

o Manages and tracks the overall study budget

o Selects, coordinates, and monitors activities of CRO and associated vendors, including participation in routine status meetings.

o Participates in the evaluation and selection of investigative sites, as well as data review and discrepancy resolution.

* Independent Investigator Initiated Research (IIR) Programs:

o Provides operational oversight of IIR concepts through the entire IIR review process (submissions, multiple levels of Incyte review and joint review with partner organizations, as appropriate) in accordance with Incyte policies and work instructions.

o Manages IIR trackers, metrics, and budget; routinely reporting overall IIR progress and ensuring timely escalation of issues to the IIR Committee and Senior Leadership.

o Establishes self as a Subject Matter Expert (SME) of the IIR submission portal; may be responsible for providing back-up support of monitoring, reviewing, routing proposals, and providing technical support.

* Educational Grants, Fellowships, and Sponsorships

o Assesses submissions in accordance with medical strategy through benchmarking; may facilitate review of requests while overseeing contracting, budget, and reconciliation activities.

* Serves as an administrator of SharePoint site for assigned projects as needed, developing site/folder structure, internal review and site content.

* Participates in the development and maintenance of standard operating procedures (SOPs) for various MA functional groups and activities.

Qualifications (Minimal acceptable level of education, work experience, and competency)

* Bachelor's degree (B.A., B.S.) is encouraged.

* Advanced degree in science or business is preferred.

* Approximately 8-10 years of experience in the pharmaceutical/biotechnology industry or related fields; approximately 7-8 years of experience in management of medical affairs programs and/or clinical study operations is preferred.

* Experience in people management responsibilities, including leadership of a team, is required.

* Proven Project Management experience is required.

* Experience managing budgets across multiple projects

* Extensive experience with MS Office Applications (including project management specific applications) is required. Experience with document management, storage and retrieval systems (such as internet-residing databases).

* Demonstrate success in developing effective solutions to complex problems.

* Demonstrate ability to understand the operating principles of the various functions within a Medical Affairs organization.

* Demonstrate ability to respond to tight and urgent timelines is essential.

* Demonstrate success in establishing successful working relationships with a diverse range of internal (e.g., commercial, R&D) and external key stakeholders (e.g., vendors, consultants).

* Must be a dependable self-starter and be capable of working independently on multiple projects with the ability to prioritize tasks and meet strict deadlines.

* Must possess excellent organization skills and be able to operate effectively in a heavily metricized organization, where a demanding workload requires balancing multiple responsibilities simultaneously.

* Must possess excellent communication and interpersonal interaction skills.

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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