Organon & Co. Director, Clinical Supply Project Manager in Madison, New Jersey
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
THIS ROLE MAY BE 100% REMOTELY BASED.
Consultant to Clinical Research team and Clinical CRO, stay informed on future study plans (i.e., BoB (book of business)), participate on clinical study teams, is consulted for all questions/issues related to clinical supplies, through all phases of compound development including LCM.
Translates clinical protocol into supply requirements from which forecasts can be built. Assesses study design to determine patient supplies for each arm/cohort of a study, in consultation with Clinical Research/CRO, contributing to protocol authoring Determines Clinical Finished Goods requirements (quantity forecasts, package design, fill count input, blinding needs), in consultation with Clinical Research/CRO Organizes clinical labeling requirements (design, text content, translation needs based on country list)Determines Drug Product requirements for all drug types (i.e. development compounds, comparators, placebos), and places Bulk orders with Manufacturing/Manufacturing CMO Outlines clinical supply manufacturing and packaging plans, aligning to meet study start targets, converts to executable orders.
Provides input to IRT URS for development of inventory management functionality, in conjunction with Clinical CRO.
Consults on distribution requirements (countries, handling, import & export) to bridge Clinical CRO/Packaging & Distribution CMOs, educate partner areas as needed on nuanced country requirements.
Provides oversight of CRO Distribution Coordinator to manage clinical supply forecasted needs vs. inventory (Drug Products, Clinical Finished Goods, stock transfers, site shipments) Inventory management activities to be done in conjunction with Clinical CRO: site seeding, expected resupply packaging requirements, reconciliation, and destruction, IRT monitoring (blinded)IRT monitoring (unblinded) as needed Identifies extension date management and inventory relabeling opportunities.
Consults and engages in study change management (design, timing, enrollment, countries) and mitigation of issues, determining what, if any, impact there may be on clinical supply plans Study changes (design, timing, enrollment, countries) Normal study LCM - (re)supply forecast adjustments.
Ensures partner areas such as Procurement, Finance, Quality, Regulatory (incl. CMC), Analytical, and Trade Compliance are informed and consulted at appropriate touchpoints.
Ensures Project Management best practices are being employed across projects including Identification and analysis of project risk management Establish mitigation/avoidance/acceptance risk plans Develop and utilize Project Plans, ADIR logs, forecasting tools Communicate, raise awareness, and escalate issues as appropriate, per Organon governance procedures.
Provides clinical supply financial forecasts for studies, in alignment with Organon Finance requirements, monitor spend vs. clinical supply budget.
Vendor relationship management, oversight, negotiation of timelines, request/review quotes.
Partner with business and procurement to source and contract external services.
Manage performance through metrics, issue resolution and continuous improvement.
Solicit and apply feedback from Service Providers and business groups to drive continuous improvement.
Coordinates manufacturing orders through Project Summaries to CRO Supply Coordinator.
Coordinates manufacturing orders through internal Organon Manufacturing Network.
Tracks progress through CRO Supply Coordinator at all CMOs including adherence to project schedules, to ensure availability of clinical finished goods to support study start targets.
Education Minimum Requirements:
Bachelor’s degree required; concentration in a scientific-related discipline strongly preferred.
Coursework/training in project management strongly preferred.
Required Experience and Skills:
At least 12 year's overall relevant work experience with at least Six (6) years of experience in clinical supply project management or related role/expertise in pharma and/or biotech.
Work independently, yet cross-functionally, regardless of complexity, phase, or program type, based on direct experience and/or the ability to translate prior experiences to a new challenge.
Ability to work in a dynamic environment, strategic and tactical, influence multiple partner groups and stakeholders both within and ex-Organon (note: this covers CRO, CMOs, and future collaborators/JVs).
Comfort engaging with strategic management or governance committees as appropriate to the role.
Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to the team and to management. Keeps both team members, departmental colleagues (as appropriate), and management fully apprised of project/initiative status and issues. Ability to communicate clearly, concisely, and professionally under pressure.
Well-developed and effective team facilitation and leadership skills; able to establish cooperative team environments. Networking skills.
Effective at energizing others, establishing clear goals, delegating responsibility, mentoring, and coaching within a team setting.
Demonstrated situational leadership and creative problem solving within departments and teams.
Able to understand project details but keep the overall “big picture” view of projects, priorities, and strategies.
Sufficient skill levels and technical understanding of product development to be recognized as a project management/product development expert within Research or Commercial divisions.
Proven ability to analyze, integrate, recommend, contribute to the development of conceptual plans for, and lead implement of, strategic, process, and team improvement and change initiatives cross functionally.
Preferred Experience and Skills:
Extensive experience with the planning and execution of strategies for drug/vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing, or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.
Demonstrated ability to manage resources, time, and budget effectively for given development projects; is business savvy and results oriented.
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.
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Flexible Work Arrangements:
Flex Time, Remote Work
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Number of Openings:
Requisition ID: R509686