Job Description
The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.
The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact representing the GCS Planning organization to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings. Working independently, the Program CSPM designs strategic and operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product. ?
Primary activities include, but are not limited to:
Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines, strategies and other related topics for all clinical supplies across all assigned program(s).
Responsible and accountable for establishing the timelines for bulk manufacturing?needs and release of drug product across assigned program(s).
Works directly in the SAP system to establish a consolidated, visible forecast for all products used within the assigned program(s) (i.e. Bulk Drug Product).
Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within assigned program(s).
Responsible for identifying significant supply risks associated with clinical bulk activities in addition to serving in a lead role for clinical supply issue escalation within their program(s) (and subsequent manage thereof) to GCS Leadership.
Responsible for the clinical supply budget for respective program(s)?and for supporting all protocol and program cost estimates requested by Product Development Teams.
Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.
Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise.
Mentors new team members and supports staff development, as neededDemonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and data?Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work?
Drive continuous improvement initiatives to enhance the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems.
Stay updated on industry trends, regulations, and best practices related to clinical supply planning and incorporate them into the team's operations.
Focus on Customers & Patients.
Make rapid, disciplined decisions.
Demonstrates Ethics & Integrity.
Required Experience and Skills:
Bachelor's degree in a scientific, business, or related discipline required, MS/MBA preferred.
At least 8 years of experience in project management.
At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent.
Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation, influencing, and relationship-building skills to ensure alignment and collaboration in the supply planning process.?
Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management.
Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel, PowerPoint, and Word
Strong Analytical & Problem Solving Skills: ability to analyze complex data, identify trends, and make data-driven decisions to optimize supply chain processes.
Flexibility & Adaptability: Demonstrates ability to thrive in a fast-paced and dynamic environment, with the capability to adapt quickly to changing business needs and priorities.?
Detail Oriented & Organized: strong attention to detail in managing complex supply chain activities; ability to multitask, prioritize tasks, and meet tight deadlines.?
Continuous Improvement Mindset: Proactive approach to identify process inefficiencies, develop solutions, and drive continuous improvement initiatives within the clinical supply planning function.
Proven record in project / portfolio management.
Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable.
Preferred Experience and Skills:
Proficiency in using supply chain management systems and software, including experience with ERP systems (e.g., SAP), demand planning tools, and inventory management systems.
Familiarity with data analytics/visualization software.
Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution.
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US and Puerto Rico Residents Only:
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$139,600.00 - $219,700.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability, Adaptability, Business, Business Risks, Change Management, Clinical Development, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System, Inventory Management, Management Process, Multiple Therapeutic Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning {+ 5 more}
Preferred Skills:
Job Posting End Date:
06/11/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R351680