Crinetics Pharmaceuticals
Senior Director, Clinical Trial Supplies
Crinetics Pharmaceuticals, San Diego, California, United States, 92189
Overview
Crinetics is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases and endocrine-related tumors. We were founded by scientists with a focus on rigorous innovation to improve lives. We have a robust discovery engine and a global preclinical and clinical development pipeline, with a patient-centric and team-oriented culture. Crinetics is known for an inclusive workplace and is dog-friendly. 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. Position Summary
The Senior Director, Clinical Trial Supplies, is an end-to-end clinical supply planning leader that provides strategic, clinical supply management in a fast-paced biotech environment. This role performs strategic, clinical supply management for its clinical development programs (phase 1, 2, 3) and supports commercial launch, reporting to the SVP, Technical Operations. The Senior Director collaborates with Global Supply Chain and Crinetics functions such as Clinical Development, Clinical Operations, Product Development & Manufacturing, Quality Assurance, Regulatory, and Project Management Office to develop and implement supply chain strategies, meet project deliverables, and create competitive advantage. The role encompasses all elements of clinical supply planning from protocol design through manufacturing to distribution and inventory management of clinical supplies at sites worldwide, requiring expert knowledge of clinical supply chain best practices in a GxP environment. Strong cross-functional, multi-cultural communication skills are required to lead in a global company; Technical Operations works with a network of CROs and CDMOs. Essential Job Functions And Responsibilities Serve as the clinical supply lead on CMC sub-teams and Clinical Operations teams for complex development programs (late phase, acquisition, partnership/alliance, new modality). Lead the development and execution of overall clinical supply strategy and management for clinical development programs, including management of IMP for global and domestic trials. Oversee and support clinical study planners in a matrix environment; facilitate issue and risk identification, mitigation, resolution, and communication. Drive cross-functional decision-making (ClinOps, PDM sub-teams) to support the long-term vision. Identify, manage, and mitigate supply risks at the program level; lead process improvements and change initiatives. Author, revise, and review SOPs, work instructions, and policies. Manage clinical supply budget for assigned programs; review and approve statements of work, purchase orders, and invoices. Influence program allocations at partners, including CMOs. Oversee contract packaging and distribution vendor operations, including budget, timelines, specifications, packaging records, labeling, distribution instructions, logistics, and QP interactions. Ensure timely execution of domestic and international distribution of Clinical Trial Materials; plan inventory at warehouses and sites; monitor usage, expiry, returns, transfers, and destruction. Forecast demands for clinical supplies and coordinate production and shelf-life extension with Drug Product and Analytical teams. Select, implement, and manage IRT systems from setup to close out with Data Management and Clinical Operations. Create and manage a global team of professionals; mentor in clinical supplies matters. Develop strategic project and resource plans for company clinical supplies; provide high-level guidance to senior management on drug supply requirements. Build and maintain a network of CROs, CDMOs, and packaging/distribution facilities appropriate to each development phase. Establish supply chain strategy for commercially available comparators, rescue medications, and ancillary medications to support trials. Integrate cross-functional internal and external teams to deliver materials fit for use and compliant with regulatory standards. Review global clinical labels and pharmacy manuals, and clinical supplies SOPs. Manage scope, cost, timelines, and quality of integrated clinical trial supplies plans. Contribute to regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other dossiers). Support Quality Assurance with implementing and managing the quality system and compliance activities, including regulatory inspections and audits. Other duties as assigned. Required Education and Experience
A bachelor’s degree in life sciences, engineering, business, or relevant discipline with at least 15 years of related technical experience in the pharmaceutical industry with increasing responsibility in clinical supplies management (or a master’s degree with at least 13 years) and a minimum of 10 years in a supervisory role. Previous experience in rare diseases or oral solid dosage forms is a plus. Prior experience building a global clinical supplies organization is highly desirable. Import/export management of drug substance and drug product, including selection of importer of record and familiarity with VAT strategies. Understanding of CGMP and CGCP, compendia testing, and ICH and regulatory guidelines including stability data requirements. Ability to collaborate in a cross-functional environment; strong project management skills. Excellent interpersonal and communication skills (written and spoken); ability to present data to peers, management, external partners, and investigators/site personnel. Experience with regulatory document preparation is desired. Ability to work in a goal- and team-oriented setting with competing priorities; detail-oriented and able to thrive under pressure. Well-developed organizational skills and awareness of industry trends, processes, and technologies. Physical Demands And Work Environment
Physical activities: sit at a desk for long periods; some walking and lifting up to 25 lbs. Typical noise level is low to moderate. Reasonable accommodations available for disabilities. Travel
Up to 20% travel may be required. Equal Opportunity Employer
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and applicants without regard to sex, sexual orientation, gender identity or expression, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or beliefs, disability, marital status, age, or protected characteristics under applicable laws. Total Compensation
The final salary offered will depend on factors including experience and education. Salary range for this position is $216,000 - $270,000. The compensation package includes a discretionary annual target bonus, stock options, ESPP, 401k match, health insurance, PTO, holidays, and company shutdown. Salary Range
$216,000 - $270,000 In addition to base pay, our total rewards program includes benefits described above. Referrals increase your chances of interviewing at Crinetics Pharmaceuticals by 2x. Get notified about new Supply Director jobs in San Diego, CA.
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Crinetics is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases and endocrine-related tumors. We were founded by scientists with a focus on rigorous innovation to improve lives. We have a robust discovery engine and a global preclinical and clinical development pipeline, with a patient-centric and team-oriented culture. Crinetics is known for an inclusive workplace and is dog-friendly. 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. Position Summary
The Senior Director, Clinical Trial Supplies, is an end-to-end clinical supply planning leader that provides strategic, clinical supply management in a fast-paced biotech environment. This role performs strategic, clinical supply management for its clinical development programs (phase 1, 2, 3) and supports commercial launch, reporting to the SVP, Technical Operations. The Senior Director collaborates with Global Supply Chain and Crinetics functions such as Clinical Development, Clinical Operations, Product Development & Manufacturing, Quality Assurance, Regulatory, and Project Management Office to develop and implement supply chain strategies, meet project deliverables, and create competitive advantage. The role encompasses all elements of clinical supply planning from protocol design through manufacturing to distribution and inventory management of clinical supplies at sites worldwide, requiring expert knowledge of clinical supply chain best practices in a GxP environment. Strong cross-functional, multi-cultural communication skills are required to lead in a global company; Technical Operations works with a network of CROs and CDMOs. Essential Job Functions And Responsibilities Serve as the clinical supply lead on CMC sub-teams and Clinical Operations teams for complex development programs (late phase, acquisition, partnership/alliance, new modality). Lead the development and execution of overall clinical supply strategy and management for clinical development programs, including management of IMP for global and domestic trials. Oversee and support clinical study planners in a matrix environment; facilitate issue and risk identification, mitigation, resolution, and communication. Drive cross-functional decision-making (ClinOps, PDM sub-teams) to support the long-term vision. Identify, manage, and mitigate supply risks at the program level; lead process improvements and change initiatives. Author, revise, and review SOPs, work instructions, and policies. Manage clinical supply budget for assigned programs; review and approve statements of work, purchase orders, and invoices. Influence program allocations at partners, including CMOs. Oversee contract packaging and distribution vendor operations, including budget, timelines, specifications, packaging records, labeling, distribution instructions, logistics, and QP interactions. Ensure timely execution of domestic and international distribution of Clinical Trial Materials; plan inventory at warehouses and sites; monitor usage, expiry, returns, transfers, and destruction. Forecast demands for clinical supplies and coordinate production and shelf-life extension with Drug Product and Analytical teams. Select, implement, and manage IRT systems from setup to close out with Data Management and Clinical Operations. Create and manage a global team of professionals; mentor in clinical supplies matters. Develop strategic project and resource plans for company clinical supplies; provide high-level guidance to senior management on drug supply requirements. Build and maintain a network of CROs, CDMOs, and packaging/distribution facilities appropriate to each development phase. Establish supply chain strategy for commercially available comparators, rescue medications, and ancillary medications to support trials. Integrate cross-functional internal and external teams to deliver materials fit for use and compliant with regulatory standards. Review global clinical labels and pharmacy manuals, and clinical supplies SOPs. Manage scope, cost, timelines, and quality of integrated clinical trial supplies plans. Contribute to regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other dossiers). Support Quality Assurance with implementing and managing the quality system and compliance activities, including regulatory inspections and audits. Other duties as assigned. Required Education and Experience
A bachelor’s degree in life sciences, engineering, business, or relevant discipline with at least 15 years of related technical experience in the pharmaceutical industry with increasing responsibility in clinical supplies management (or a master’s degree with at least 13 years) and a minimum of 10 years in a supervisory role. Previous experience in rare diseases or oral solid dosage forms is a plus. Prior experience building a global clinical supplies organization is highly desirable. Import/export management of drug substance and drug product, including selection of importer of record and familiarity with VAT strategies. Understanding of CGMP and CGCP, compendia testing, and ICH and regulatory guidelines including stability data requirements. Ability to collaborate in a cross-functional environment; strong project management skills. Excellent interpersonal and communication skills (written and spoken); ability to present data to peers, management, external partners, and investigators/site personnel. Experience with regulatory document preparation is desired. Ability to work in a goal- and team-oriented setting with competing priorities; detail-oriented and able to thrive under pressure. Well-developed organizational skills and awareness of industry trends, processes, and technologies. Physical Demands And Work Environment
Physical activities: sit at a desk for long periods; some walking and lifting up to 25 lbs. Typical noise level is low to moderate. Reasonable accommodations available for disabilities. Travel
Up to 20% travel may be required. Equal Opportunity Employer
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and applicants without regard to sex, sexual orientation, gender identity or expression, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or beliefs, disability, marital status, age, or protected characteristics under applicable laws. Total Compensation
The final salary offered will depend on factors including experience and education. Salary range for this position is $216,000 - $270,000. The compensation package includes a discretionary annual target bonus, stock options, ESPP, 401k match, health insurance, PTO, holidays, and company shutdown. Salary Range
$216,000 - $270,000 In addition to base pay, our total rewards program includes benefits described above. Referrals increase your chances of interviewing at Crinetics Pharmaceuticals by 2x. Get notified about new Supply Director jobs in San Diego, CA.
#J-18808-Ljbffr