Senior Specialist, Clinical Supply Project Manager - Protocol (Hybrid)

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.   

Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned studies, which could vary in complexity. This individual serves as the primary GCS point of contact to stakeholders 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 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: 

• 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'

• Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics. 

• Responsible and accountable for establishing the timelines for clinical supply needs per study and providing the signal for sourcing, manufacturing, packaging, and distribution  for our company's development products and non-company 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.  

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

• 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. 

• Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities. 

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

• 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​
• Focus on Customers & Patients.​
• Make rapid, disciplined decisions. 
• Demonstrates Ethics & Integrity. 

Required Experience and Skills:  

• Bachelor’s Degree in scientific, business, or related discipline required. 

• At least 5 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. 

• Proficiency in using supply chain management systems and software, including experience with ERP systems (e.g., SAP), demand planning tools, and inventory management systems. 

• Proven record in project / portfolio management. 

• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable. 

Preferred Experience and Skills:   

• Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise  

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

#eligibleforERP

GCSCareer

VETJOBS

PSCS

GCSCareer24 

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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

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:

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.

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

Search Firm Representatives Please Read Carefully 
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.