at Incyte Corporation in Wilmington, Delaware, United States
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 Medical Operations Budget Manager will provide management of the US investigator initiated research (IIR) submission and review process and be responsible for budget negotiation process to ensure ethical, fair and compliant practices are followed when reviewing, analyzing, negotiating and finalizing investigator initiated study budget and milestones in association with investigator initiated research agreements. This position necessitates leadership, collaboration, direction, and guidance through process improvement, interactive communication and stakeholder management. This role requires a high level of interactive communication with USMA medical directors, IIR program managers, global medical affairs, legal counsel and external institutions.
Essential Functions of the Job (Key responsibilities)
Operationally lead the US IIR Submission and Review process in collaboration with USMA Medical Directors, IIR program managers, Medical Science Liaisons and Global Medical Affairs
Review and analyze investigator initiated study budgets in accordance with Fair Market Value and leverage historical data, will liaise with the site concerning the budget as appropriate
Review and discuss study milestone deliverables with investigators and institutions to reach a shared understanding of timely study start-up, enrollment and financial obligations.
Be responsible for finalizing and approving investigator initiated study budget, milestones and appropriate Payment Schedules based on the Protocol and Incyte policy and guidelines to provide to USMA project managers, legal.
Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
Ensure final contract documents are consistent with agreements reached at negotiations.
Collaborate with internal stakeholders within a cross-functional team to ensure timely, quality execution of activities and projects.
Collaborate with Incyte USMA project managers, investigators and site staff to ensure timely study start up, activation, execution and closeout of IIRs as well as FMV budget assessment and contract finalization, in close collaboration with legal colleagues.
Enable active cross-functional communication among different USMA functional leads, GMA and Clinical Development through appropriate methods; sets meeting logistics , prepares meeting agendas and minutes, and provides meeting facilitation of various teams and sub teams (as appropriate).
Manage financial activities, including USMA IIR budget and forecasts for assigned projects in collaboration with IIR program managers, Operations Director and Finance.
Collect, collate and report on assigned USMA project metrics.
Develop and apply metrics for deliverables under his/her purview.
Assist in the development, refinement, and maintenance of standard operating procedures (SOPs) and systems for various USMA functional groups and activities.
Support internal and external audits and litigation activities.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor degree (B.A., B.S.) is required. Minimum of 5 years of experience in the pharmaceutical/biotechnology industry/ health care industry or related business management fields.
Strong interpersonal, negotiation, communication and time management skills.
Experienced user of FMV tool, specifically IQIVIA Grant Plan Investigator.
Preferred experienced user of IIR web based submission /management system (IQVIA/Polaris/SteepRock)
Strong oral, written, and organizational skills.
Demonstrated high level of competence with computers is essential.
Extensive experience with MS Office Applications is required.
Demonstrate success in developing effective solutions to complex problems is required.
Demonstrate success in establishing successful working relationships with a diverse range of internal and external key stakeholders.
Possess good analytical and... For full info follow application link.
We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.
1801 Augustine Cutoff
Wilmington, Delaware 19803