Crinetics Pharmaceuticals
Senior Manager, Clinical Trial Supplies
Remote, USA · Senior
Sponsorship not specified$140k-$175kDetected 76 days ago
Project ManagementForecastingSupply ChainInventory ManagementPerformance ManagementClinical TrialsGMPFDA RegulatoryExperimental DesignAnimal StudiesLeadershipCommunicationOrganizational SkillsDemand PlanningRegulatory Affairs
About the role
- The Senior Manager, Clinical Trial Supplies is responsible for the planning, execution, and oversight of global clinical trial supply operations across multiple clinical programs.
- Essential Job Functions and Responsibilities:
- These may include but are not limited to:
Responsibilities
- 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.
- Manage clinical trial supply lifecycle activities, including forecasting, demand planning, packaging, labeling, distribution, returns, and destruction.
- Manage Interactive Response Technology (IRT) system builds, UAT testing, supply strategies and reconciliation activities.
- Influence study design decisions to optimize supply chain efficiency and patient experience.
- Lead selection, contracting, and performance management of external vendors (CMOs, depots, couriers, IRT providers).
- Develop and manage clinical supply budgets, vendor quotes, proposals, and timelines.
- Drive cost optimization while maintaining quality and compliance.
- Confirm production plans and shipping schedules; develop depot/site resupply strategies and coordinate packaging schedules with third-party provider(s) to support clinical demand changes, i.e., change in distribution timelines for new studies, enrollment changes, additional sites, etc.
Requirements
- Partner closely with Clinical Operations, Manufacturing, Quality, Regulatory Affairs, Finance, and external vendors as required to ensure alignment on study timelines and deliverables.
Nice to have
- Minimum of a Bachelor's in life sciences, nursing, business or related field with at least 12 years of related technical experience.
- Previous experience in Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination.
- Previous experience in rare diseases /oral solid dosage forms is a plus.
- Import and export management of drug substance and drug product.
- Understanding of CGMP and CGCP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements.
- Excellent interpersonal and communication skills (written and oral).
- Experience with preparation of regulatory documents is desired.
- Excellent ability to work in a goal and team-oriented setting and to handle competing priorities.
Compensation
- The salary range for this position is: $140,000 - $175,000.
- In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
Benefits
- Environmental health and safety requirements also apply.
- In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
- We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Company info
- 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.
Equal opportunity
- Employer:
- Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
- Crinetics is proud to be an Equal Opportunity Employer.
- We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Visa & Work Authorization
- tation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union s
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