Associate Director, Clinical Supply Project Manager - Program (Hybrid)
Associate Director, Clinical Supply Project Manager - Program (Hybrid)
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$ 139600 - 219700
1 Vacancy
Job Description
Job Description
The Global Clinical Supply (GCS) organization is accountable for managing the endtoend integrated clinical supply chain across our Companys 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 programlevel 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 manufacturingneeds 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 nonpipeline 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 dataDemonstrates 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 teams operations.
Focus on Customers & Patients.
Make rapid disciplined decisions.
Demonstrates Ethics & Integrity.
Required Experience and Skills:
Bachelors degree in a scientific business or related discipline 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 crossfunctional teams senior management external vendors and clinical sites. Strong negotiation influencing and relationshipbuilding 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 datadriven decisions to optimize supply chain processes.
Flexibility & Adaptability: Demonstrates ability to thrive in a fastpaced 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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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$139600.00 $219700.00Available 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
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Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/16/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
