Associate Director, Clinical Supply Project Manager - Program - Hybrid

Merck; Rahway (NJ); Ibrido; USD 142.000 - 224.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Dental benefits

Vision benefits

401(k)

Paid holidays

Descrizione del lavoro

Merck is seeking an Associate Director, Clinical Supply Project Manager (Program) within Global Clinical Supply - Planning to lead end-to-end planning for multiple clinical studies. You will partner with clinical development, regulatory, quality and supply chain teams to design strategic and operational plans, balancing patient needs with supply stability.

You will build timelines, manage bulk drug production and release, run SAP-based forecasts, and oversee budget and cost estimates.

Competenze

• Bachelor’s degree in a scientific, business, or related discipline.
• 8+ years of experience in project management and clinical supply planning.
• Strong communication, negotiation, and stakeholder management skills.
• Familiarity with SAP or Oracle and MS Office (Excel, PowerPoint, Word).
• Knowledge of GMP/GCP preferred.

Mansioni

• Lead GCS Planning program representation with clinical development, regulatory, and QA.
• Establish timelines for bulk manufacturing and release of drug product.
• Develop a consolidated SAP forecast for products used in programs.
• Oversee bulk drug supply management and allocation across studies.
• Identify supply risks and escalate issues to GCS leadership.
• Own the clinical supply budget and assist with cost estimates.
• Author documentation for labeling, packaging, and CMC activities.
• Mentor team members and support staff development.

Descrizione del lavoro

Associate Director, Clinical Supply Project Manager - Program

Global Clinical Supply - Planning

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our Research & Development Division's 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 Supply 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 needed
• Demonstrates 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.
• Contribute to departmental strategy and participate in cross-functional projects as required by the therapeutic area leadership to drive continuous improvement & efficiency efforts.
• 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, clinical supply planning, scheduling, coordination and processing of supply chain activities, pharmaceutical development, clinical operations, or related biopharmaceutical functions.
• 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.

Required Skills

Clinical Development, Data Analysis, Project Management, Strategic Thinking

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

• EEOC Know Your Rights
• EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

Location

The primary location for this posting is:

USA - Pennsylvania - West Point

Compensation

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional Location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional Location(s) Compensation Information

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

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

No

Job Posting End Date

10/30/2026

• 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

R422498