Job Description

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our Research & Development Division portfolio of clinical trials. GCS supports more than 300 Phase I-IV clinical trials run in-house, 400 outsourced or run by partners, and 300 our company's ISS clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60 countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures.

The GCS Clinical Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. Clinical Supplies Project Managers (CSPMs) are responsible for the translation of global clinical study demand into supply plans and are accountable for all delivery of clinical finished goods materials to initiate trials on time and maintain patient continuity of supply.

Working independently, the CSPM designs strategic and operational plans for all activities associated with their assigned clinical studies within a given development program (CSPM Protocol Manager) and/or all clinical supplies across an entire compound program (CSPM Program Manager). The incumbent is expected to have a strong understanding of drug development, clinical research, and/or clinical supply chain, as well as interpersonal skills with a demonstrated ability to negotiate with key stakeholder groups and drive/influence results in a dynamic environment.

The CSPM Protocol Manager serves as the primary protocol-level GCS point of contact for given protocols to customers both internal and external to GCS and serves as the GCS spokesperson at clinical development related meetings (i.e., Clinical Trial Teams) and product development related meetings.

The CSPM Program Manager serves as the primary program-level GCS point of contact representing the GCS Planning Team to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical development related meetings that impact the clinical program (i.e. Clinical Supply Program Team, Clinical Development Sub-Team) as well as product development related meetings.

Primary activities include, but are not limited to:

General Activities:

• Interacts with various organizations, as a lead GCS Planning program representative, such as Clinical Sciences and Study Management (CSSM), Regulatory, CMC, Pharmaceutical Sciences, Formulation Development, and Global Development Quality as necessary to address drug supply related topics.

• Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).

• Responsible and accountable for utilizing key tools in the planning and managing of clinical supplies for assigned program(s). This may include Microsoft Project Plans, Actions, Issues and Risk (ADI) Logs, forecasting tools (SAP), etc.

• Support the collection of clinical supply chain metrics to describe business health and the identification of areas for operational improvement.

• Responsible for initiating none of our company's marketed drug product planning activities for new protocols.

• Serves in a support or lead role for clinical supply issue escalation to GCS Leadership (as issue owner or in support of other CSPMs that support assigned programs)

• Mentors new team members and supports staff development, as needed.

• Participates as a lead business process owner or SME in a particular area of expertise.

• Champions and drives identified business process improvement initiatives, as needed.

CSPM Protocol Manager Specific:

• Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.

• Responsible and accountable for establishing the timelines for clinical supply needs per protocol and providing the signal for sourcing, manufacturing, packaging, and distribution for development products and none of our company's marketed products.

• Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.

• Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols.

• Participate in Interactive Voice Response (IVR) System development and User Acceptance Testing (UAT) for assigned studies.

CSPM Program Manager Specific:

• Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across assigned program(s)

• Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s)

• Responsible for identifying significant supply risks associated with clinical bulk requirements.

• Responsible for the clinical supply budget for respective program(s) and for supporting all protocol and program cost estimates requested by Product Development Teams

• Chairs the Clinical Supply Program Team (CSPT) and works closely with Clinical Team Leads, Project Management (PM), CMC, Regulatory and other functional area representatives to negotiate timelines and strategy for clinical supplies across all assigned program(s)

• Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.

• Ensures GCS Planning Leadership is aware of program pipeline forecast to ensure proper resourcing of all levels of planning support.

Minimum education required:

• Bachelor’s degree in a scientific, business, or related discipline required, MS/MBA preferred.

Required Experience and Skills:

• At least 8 years of experience in project management

• At least 3 years of experience in planning, scheduling, coordination and processing of clinical supply activities, or the equivalent

• Understanding of MRP systems and demand planning principles

• Strong organizational, time management and problem solving skills

• Results oriented with the proven ability to execute on collaborative projects and develop subject matter expertise Exceptional written and verbal communication and relationship skills along with high personal integrity, credibility, and energy.

• Ability to prioritize tasks and initiatives appropriately to mitigate supply risks.

• Advanced proficiency in Microsoft Excel, PowerPoint, and Word.

• Experience with change management and leading process improvement initiatives.

Preferred Experience and Skills:

• Demonstrates ability to negotiate, resolve conflicts and engage in decision making as well as partner and influence across functional areas and organizations.

• Strong knowledge of the principles of project management and clinical customer relationship management.

• Knowledge of drug development, production, distribution, shipping, destruction, and reconciliation processes and procedures.

• Knowledge of order management, supply chain operations and document control.

• Experience leading teams and developing direct reports

• Familiarity with data analytics/visualization software.

• Familiarity with SAP as an ERP/MRP system.

• Familiarity with GMP requirements, quality procedures, and SOP execution.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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Relocation:

VISA Sponsorship:

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Flexible Work Arrangements:

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Requisition ID:R225200