Merck Executive Director, Clinical Supply Operations in West Point, Pennsylvania

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Global Clinical Supply (GCS) is the organization within Merck Research Laboratories (MRL) that is responsible for managing an 'end-to-end' integrated clinical supply chain, supporting all Phase I-IV clinical programs. The organization includes Planning (in collaboration with clinical partners to translate clinical protocol/study design into clinical supply strategy), Packaging and Labeling of supplies, End to End Supply Preparation (managing operational siting, inventory and systems), MRL Logistics (overseeing the shipment and export & import of MRL research samples and clinical supplies), and outsourcing of operational activities.

The scope of responsibility of GCS has expanded significantly over the recent years. Most notably, the complexity, volume and workload associated with clinical trials has increased due to a large number of new trials in the oncology space, new regulations related to Global Trade Compliance and Value for Customs, balancing internal headcount versus flexible insourced resources and outsourced capabilities and capacity, and the introduction of new technologies.

Through clinical supply and trial stakeholder alignment (Clinical Supply Chain Council) GCS is driving further the operational integration of manufacturing, packaging and labeling and distribution of the supplies, and the alignment with quality and compliance assurance (through MRL Quality, Trade Compliance and Finance). This will allow significant supply timeline and resource savings, and expedited development of projects in Merck’s development pipeline.

To enable these opportunities, the following is required:

  • Total Cost of Ownership alignment and Budget Prioritization, allowing the introduction and implementation of innovative technologies which will redefine the clinical supply chain regarding costs, compliance and patient centricity.

  • Resource capacity (Merck, insourced, outsourced) needs to be balanced across all GCS operational areas, ensuring flexible and agile operational resource adjustments and rotations.

  • Budgetary impact by including more freight, increased complexity of freight and impact of redefined Value for Customer Purpose (VCP) and VAT calculation models need to be monitored and forecasted.

  • Integration of packaging, labeling distribution for the clinical supply (secondary) depot network, and direct to patient opportunities will need to be developed.

  • Trade Compliant integrated operations need to be developed for Clinical Supply and Research & Discovery shipments across the globe.

  • Integrated operational oversight systems (SAP NextGen, Global Trade Automated System, Inventory Management, Operational Planning etc.) need to cover the integrated operations opportunities, while connecting to the commercial supply chain systems.

Responsibilities:

The Executive Director Clinical Supply Operations will be responsible for managing staff, overseeing operations, managing budgets, establishing, enforcing company policies and procedures, and developing a strategic plan for integrated packaging and labeling and distribution. The individual is the primary liaison between Merck sites worldwide and other operational areas within Merck (Pharmaceutical Sciences, Merck Manufacturing Division (MMD), Biologics and Vaccines Manufacturing, MRL and MMD Packaging and Logistics, etc.). Close collaboration to realize synergies with both R&D and Commercial Supply Chain partners is critical.

The Executive Director:

  • Leads directly a team of Merck Managers, and indirectly over 60 operational staff, responsible for the packaging, labeling, distribution and trade operations for all clinical supplies in the Merck portfolio

  • Develop leaders and talent in line with Merck’s leadership behaviors, by building talent, developing expertise, strengthening leadership skills and fostering a culture of innovation

  • Manages operational budget and resources (incl. Merck, insourced and outsourced resources, facilities and equipment) across packaging, labeling, distribution and trade operations for all clinical supplies

  • Ensures quality and compliance of clinical supply finished goods supply for all clinical trials in the Merck portfolio

  • Drives the End-to-End Clinical Supply Chain strategy and operational model, incl. integrated operations (if possible and feasible incl. integration with manufacturing)

  • Develops and maintains an effective and efficient collaboration model within Merck to perform and operate as an end-to-end clinical supply chain (incl. IT, MRL and MMD Operations, Finance, Compliance, Quality, Procurement, Early & Late Clinical R&D)

Education Requirement:

  • Master's degree in related field required

Required:

  • At least 5-10 years of experience in Analytical Chemistry or (Clinical) Supply Chain, Pharmacist, or experience in Clinical Operations or Pharmaceutical Sciences

  • Strong negotiation and influencing ability at all levels in the organization

  • Strong leadership and communications skills

  • Strong business acumen

  • Strong mind-set for strategic concepts, and innovation and out-of-the-box solutions.

  • Collaborative nature—need to be able to connect and get things done across the GCS and the Merck organizations

  • Ability to anticipate conflictive environments, and manage to facilitate the resolution of complex issues

  • Experience managing budgets, programs and staff

  • Experience in leading and managing a global organization with a diverse group of experienced and motivated staff

  • Ability to make rapid, disciplined decisions and to prioritize work

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Supply Chain Dev&Optimization

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-PA-West Point

Title: Executive Director, Clinical Supply Operations

Primary Location: NA-US-NJ-Rahway

Requisition ID: SUP001416