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 Manager will provide management and coordination of the US region investigator initiated research (IIR) submission and review process, program management of pre-clinical IIRs and study support to program managers for USMA lead company sponsored trials. 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, pre-clinical colleagues 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, Global Medical Affairs and applicable Alliance Partners.
Operational management of pre-clinical IIRs to include start up activities, contract management, drug and financial management
SteepRock vendor management for US IIRs and training for new USMA users
Provide operational and project management support for US Medical Affairs activities, which may include USMA company-sponsored interventional, non-interventional and RWE trials, Investigator Initiated Research Studies, Expanded Access Programs, Core Medical Team projects.
Collaborate with Investigators and/or CRO as applicable and site staff to ensure timely study start up, activation, execution and closeout of IIRs, CSTs as well as FMV budget assessment and contract finalization, in close collaboration with legal colleagues.
Collaborate with internal stakeholders within a cross-functional team to ensure timely, quality execution of activities and projects.
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).
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, communication and time management skills.
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 problem solving skills.
Demonstrate ability to prioritize and manage multiple tasks with conflicting deadlines.
Proven ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
Maintain team oriented and flexible approach, possess ability to respond quickly to shifting demands and opportunities.
Must be a dependable self-starter. Must be capable of working independently on multiple projects with the ability to prioritize tasks and meet strict deadlines.
Good medical knowledge in relevant Incyte Therapeutic Areas.
Good understanding of drug development process and clinical study management including monitoring, study... 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