Description:
This position is responsible for operational oversight and support of multiple US Medical Affairs (USMA) projects and contributes to the development of project timelines and priorities. Required to be in the office 4 days per week allowing for 1 day remote.
Essential Functions Of The Job (Key Responsibilities)
Advisory Board & Consulting Agreement Management:
- Partner with USMA colleagues to support timely execution of agreements for advisory boards and other consulting engagements.
- Perform fair market value (FMV) assessment on each advisor, considering qualifications, consulting hours, and travel requirements as applicable.
- Coordinate negotiation and execution of consulting agreements between legal teams and external consultants.
- Collaborate with third-party vendors to support planning and logistics as needed.
- Support the submission of purchase orders (POs) related to consulting agreements.
- Maintain a centralize tracker to monitor and document both planned and completed advisory boards throughout the year.
Investigator-Initiated Research (IIR) Submission And Review
- Provides operational leadership for the US Oncology IIR submission and review process, working collaboratively with USMA Medical Directors, IIR Program Managers, Medical Science Liaisons (MSLs), Clinical/Pre-Clinical Development, and relevant Alliance Partners.
- Facilitate effective cross-functional communication among USMA functional leads, Clinical Development, and other key stakeholders by leveraging appropriate communication methods. Responsibilities include coordinating meeting logistics, developing agendas, documenting minutes, and providing facilitation support for various teams and sub-teams, as needed.
- Maintain and continuously update IIR trackers and performance metrics to ensure accurate, real-time portfolio visibility; proactively identify risks and escalate issues to management to enable timely resolution and strategic decision-making.
- Oversee the vendor relationship for US Oncology IIRs, ensuring alignment with contractual obligations and operational expectations; deliver comprehensive training to new USMA users on the IIR platform and provide ongoing support for external stakeholders, including troubleshooting access issues and facilitating system navigation.
Project Management Of Pre-Clinical IIRs
- Provides operational oversight of early-stage research initiatives, including startup activities, contract coordination, and management of drug supply and financial processes.
- Collaborate with Investigators and site staff to ensure timeline study start up, activation, execution and closure of studies, as well as FMV budget assessment and contract finalization, in close collaboration with legal colleagues.
Other Activities And Operational Support
- Participates in the development and maintenance of standard operating procedures (SOPs) for various MA functional groups and activities.
- Develop and implement performance metrics to monitor and evaluate progress within areas of responsibility.
Qualifications (Minimal acceptable level of education, work experience, and competency):
- Bachelor degree (B.A., B.S.) is required.
- Experience in the pharmaceutical/ biotechnology industry or related fields.
- Proven Project Management experience is required.
- Demonstrated high level of competence with computers is essential; to include extensive experience with MS Office Applications (including project management specific applications) is required. Experience with document management, storage and retrieval systems is also required.
- Demonstrated success in establishing successful working relationships with a diverse range of internal and external key stakeholders.
- 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 flexibility and balancing multiple responsibilities simultaneously.