Associate Director Operations, Global Medical Affairs, Strategic Planning and Operations

Eisai•Nutley, NJ

2d•Hybrid

About The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Oversees the direction, planning, execution, clinical trials/research and the data collection activities. Contributes to implementation of clinical protocols, and facilitates completion of final reports. Recruits clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases III? IV for company products under development. Participates in adverse event reporting and safety responsibilities monitoring. Coordinates and provides reporting information for reports submitted to the regulatory agencies. Monitors adherence to protocols and determines study completion. Coordinates and oversees investigator initiations and group studies. May participate in adverse event reporting and safety responsibilities monitoring. May act as consultant/liaison with other corporations when working under licensing agreements. Job Summary The Associate Director Operations, Global Medical Affairs, Strategic Planning and Operations, role on a high level will support the day-to-day operations of the Global & US Medical Affairs team through their close work with all Gl & US Medical Affairs Oncology functions as part of the Strategic Planning & Operations team. He/she will have an integral role leading information consolidation for Global and US Strategic Planning and Operations, assisting with fiscal responsibilities including procurement, meeting and process management, IIS Program Project Management alliance management and cross functional communications. The AD, Operations, Global Medical Affairs, Strategic Planning and Operations will oversee contract and vendor management for our team, serving as a facilitator of legal and purchasing processes and assist in contract negotiation, performance management, work orders and contracts. He/she will create, review, and track requisitions, and invoices Identify opportunities to add value in Medical Affairs, bring enhancements to Medical Affairs processes, and ensure alignment of Medical Affairs work to corporate Standard Operating Procedures (SOPs). The incumbent will provide process, SOP and SWP support to Medical Affairs Oncology US and regions and will also provide internal and alliance meeting support. He/she will assist in ensuring best practices, meeting facilitation and follow up of actions across various Medical Affairs Oncology meeting working closely with the Gl & US Strategic Planning and Operations team. He/she will assist and may lead in communications associated with Investigator Initiated Studies and ensure timely responses and resolutions to investigator and internal stakeholder requests and related issues. metrics, and provides regular updates to key business partners with respect to trial progress, milestones, trial costs, timeline forecasts and trial outcomes and publications.

Requirements

A minimum of 7 plus years of overall related experience, including 5 years project management experience (10+ years relevant work experience in a pharmaceutical/biotech industry highly preferred)
BS or BA in a related field; advanced degrees preferred
Demonstrated project management ability, with excellent communication skills and the ability to influence non direct reports
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Willing to get involved in ad hoc projects with a can-do attitude
Proactive, resourceful, self-motivated, and should possess exemplary interpersonal skills to interact professionally with all levels in the organization
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Excellent written and verbal skills; superior organizational skills.
Highly articulate with an ability to foster the trust and respect of peers, and superiors
Highly proficiency in MS Office tools, specifically Excel, PowerPoint, MS Teams, Outlook
BS or BA degree

Nice To Haves

PMP certified preferred

Responsibilities

Financial oversight: work closely with all to facilitate and lead the end-to-end procurement process ensuring process and oversight.
Work closely with all stakeholders and liaise with administrative support to ensure all processes and work.
Support the day-to-day operations of the Global & US Medical Affairs team through working with all team members.
Proactively assisting with and participating in special initiatives and various workstreams.
Provide internal and Alliance meeting organization and assistance ensuring best practices, meeting facilitation and follow up of actions across various Medical Affairs Oncology through working closely with the Gl & US Strategic Planning and Operations team.
Provide process, SOP and SWP support to Medical Affairs Oncology regions.
Work closely with the Director of Studies, U.S. Medical Directors and Field Team in responsibilities associated with U.S. Investigator Initiated Studies.
Ensures timely responses and resolution to U.S. investigator and internal stakeholder requests and related issues.
Metrics: provides regular updates to key business partners with respect to trial progress, milestones, trial costs, timeline forecasts and trial outcomes and publications.
Assist in all contracts, contract amendments and study close-out activities.
Assist in facilitation of quarterly Global IIS Committee meetings, collection of materials, and all follow-up needs.
Deliver essential program management expertise to ensure alignment of Global and US Medical Affairs to the overarching business objectives and needs.
This support enables team members to focus on their core responsibilities and excel by helping to eliminate operational barriers.
IIS Program: Collaborate closely with the Global and US IIS Program Lead to ensure timely delivery of program milestones.
Responsibilities include preparing and reviewing meeting materials, documenting minutes, and follow-ups, organizing content on SharePoint, and compiling proposal reviews.
Serve as a liaison with KOLs for US IIS studies, supporting recruitment, tracking milestones and metrics, managing contracts, and overseeing study closeout activities.
Strategic Operations Support: Assist the Senior Director of Strategic Planning and Operations in leading and managing all aspects of Global and US Medical Affairs meetings, special projects, and operational needs.
This includes scheduling global meetings, developing materials, coordinating follow-ups, and engaging with regional stakeholders as needed.
Cross-Functional Collaboration: Partner with Global and US Medical Affairs teams, administrative staff, procurement, legal, and compliance to ensure timely execution of procurement and vendor management processes.
Support contract development, vendor coordination, PO creation, invoice processing, and project closeout.
Facilitate IIS Program contract amendments and study closures with participating sites.
Budget Oversight: Work in close partnership with the Senior Director of Strategic Planning and Operations to manage budgets for both Global and US Medical Affairs, ensuring fiscal accountability and alignment with the functional and Eisai’s financial goals.

Benefits

Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits

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