Crinetics
Healthcare
SeniorManager,ClinicalTrialSupplies
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Manager, Clinical Trial Supplies at Crinetics. Skills: Clinical trial supply strategies, Clinical supply chain management, Global clinical trial supply operations, Investigational product management, Vendor management, Budget management. Planning, execution, and oversight of global clinical trial supply operations. Ensuring timely, compliant, and cost-effective delivery of investigational products, ancillary supplies, and related materials”
What You'll Achieve.
Ensure the timely, compliant, and cost-effective delivery of investigational products (IP), ancillary supplies, and related materials to support clinical studies across all phases; Optimize supply chain efficiency and patient experience
Industry & Context.
Assess and mitigate supply risks
Travel up to 5% of your time, Some walking and lifting up to 25 lbs. may be required, Biology and chemical laboratory environment experience needed, Environmental health and safety requirements also apply
What They're Looking For.
Must Have
Bachelor's in life sciences, nursing, business or related field with at least 12 years of related technical experience, Minimum of a Bachelor’s in life sciences, nursing, business or related field with at least 12 years of related technical experience, Master’s degree with 8 years of experience, Previous experience in Project Management, Previous experience in Pharmaceutical Development, Previous experience in Clinical Supply Management, Previous experience in Clinical Trials Coordination, Import and export management of drug substance and drug product, Understanding of CGMP and CGCP requirements, Understanding of compendia testing, Understanding of ICH and regulatory guidelines including stability data requirements, Excellent interpersonal and communication skills (written and oral), Ability to effectively and accurately present data to peers, management, and external partners, Excellent ability to work in a goal and team-oriented setting, Ability to handle competing priorities, Flexibility within a rapidly changing environment, High attention to details, Well-developed organizational skills, Ability to thrive under pressure, Well-versed in industry trends, emerging business processes and technologies
Nice to Have
Previous experience in rare diseases /oral solid dosage forms is a plus, Experience with preparation of regulatory documents is desired
What You'll Do.
and oversight of global clinical trial supply operations
and cost-effective delivery of investigational products
and related materials
Providing leadership to supply chain teams
Acting as a subject matter expert in clinical supply chain strategy and execution
Developing and leading end-to-end clinical supply strategies
Designing optimized supply models
Assessing and mitigating supply risks
Managing clinical trial supply lifecycle activities
Ensuring uninterrupted supply of investigational and comparator products
Managing IRT system builds
supply strategies and reconciliation activities
Influencing study design decisions
and performance management of external vendors
Developing and managing clinical supply budgets
Driving cost optimization
Confirming production plans and shipping
Developing depot/site resupply strategies
Coordinating packaging schedules
Coordinating the review and approval of provider documentation
Planning and overseeing the implementation of expiry date extensions
Coordinating the assessment of and tracking temperature excursions
Supporting the transportation and disposition of returned/unused materials
Managing activities needed to source comparators and ancillary products
Planning supply strategies
labeling and distribution activities
Supporting the development of Standard Operating Procedures (SOPs) and guidelines
Supporting CMC team as needed
How You'll Work.
Team & Collaboration
Partners cross-functionally with Clinical Operations, Manufacturing, Quality, and Regulatory; Partner closely with Clinical Operations, Manufacturing, Quality, Regulatory Affairs, Finance, and external vendors; Serve as the clinical supply representative on study teams and governance forums
Communication Scope
Excellent interpersonal and communication skills (written and oral); Ability to effectively and accurately present data to peers, management, and external partners
Process & Methodology
Project Management, Develop detailed project plans and timelines for packaging, release, and distribution of clinical supplies
Full Job Description
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Senior Manager, Clinical Trial Supplies is responsible for the planning, execution, and oversight of global clinical trial supply operations across multiple clinical programs. This role ensures the timely, compliant, and cost-effective delivery of investigational products (IP), ancillary supplies, and related materials to support clinical studies across all phases. The Senior Manager provides leadership to supply chain teams, partners cross-functionally with Clinical Operations, Manufacturing, Quality, and Regulatory, and acts as a subject matter expert in clinical supply chain strategy and execution. Essential Job Functions and Responsibilities: These may include but are not limited to: · Develop and lead end-to-end clinical supply strategies for multiple clinical programs and phases (Phase I–IV). · Design optimized supply models, including labeling, packaging, distribution, and inventory strategies. · Assess and mitigate supply risks, including demand uncertainty, enrollment variability, and manufacturing constraints. · Manage clinical trial supply lifecycle activities, including forecast
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