Crinetics Pharmaceuticals
Associate Director, Clinical Trials Supplies
Crinetics Pharmaceuticals, San Diego, California, United States, 92189
Overview
Associate Director, Clinical Trials Supplies – Crinetics Pharmaceuticals. This position will perform strategic, clinical supply management for development programs (phase 1, 2, 3) and reports to the Director, Clinical Trial Supplies. The Chemistry, Manufacturing and Controls (CMC) team collaborates with a global network of CROs and CDMOs. Responsibilities
Manage contract packaging and distribution vendor operations for Crinetics’ sponsored ongoing and upcoming clinical trials, including budget, timelines, review of specifications, master and executed packaging records, labeling, distribution instructions, logistics, and QP interactions. Plan and execute domestic and international distribution of Clinical Trial Materials for all therapeutic programs. Manage inventory at warehouse and site levels including monitoring drug supply usage, expiry dates, drug returns, field transfers, and destruction. End-to-end management of IRT systems, from set up to close out. Oversee work at CROs, CDMOs, packaging and distribution facilities. Integrate cross-functional internal and external teams across CMC, clinical operations, regulatory affairs, and quality assurance to deliver clinical trial materials. Author global clinical labels, pharmacy manuals, and clinical supplies Standard Operating Procedures. Support preparation of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers). Support Quality Assurance with implementation and management of the quality system and compliance activities, including inspections by regulatory agencies and audit functions. Education And Experience
Bachelor's degree with at least 10 years of related clinical trial supply experience with increasing responsibility in biopharmaceutical development with 7 years of supervisory/leadership experience. 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). This includes the ability to effectively and accurately present data to peers, management, and external partners. Experience with preparation of regulatory documents is desired. Excellent ability to work in a goal and team-oriented setting and to handle competing priorities. Flexibility within a rapidly changing environment and high attention to details. Well-developed organizational skills and the ability to thrive under pressure. Well-versed in industry trends, emerging business processes and technologies. Technical Knowledge Required
Must have excellent PC-based computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, Project), and IRT/RSTM Systems. Knowledge of other software: Visio. Physical Demands And Work Environment
Physical Activities: On a continuous basis, sit at a desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel
You may be required to travel for up to 20% of your time. 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. Total Compensation
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Salary Range
The salary range for this position is: $150,000 - $188,000. 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 health insurance plans for employees (and their families) including medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
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Associate Director, Clinical Trials Supplies – Crinetics Pharmaceuticals. This position will perform strategic, clinical supply management for development programs (phase 1, 2, 3) and reports to the Director, Clinical Trial Supplies. The Chemistry, Manufacturing and Controls (CMC) team collaborates with a global network of CROs and CDMOs. Responsibilities
Manage contract packaging and distribution vendor operations for Crinetics’ sponsored ongoing and upcoming clinical trials, including budget, timelines, review of specifications, master and executed packaging records, labeling, distribution instructions, logistics, and QP interactions. Plan and execute domestic and international distribution of Clinical Trial Materials for all therapeutic programs. Manage inventory at warehouse and site levels including monitoring drug supply usage, expiry dates, drug returns, field transfers, and destruction. End-to-end management of IRT systems, from set up to close out. Oversee work at CROs, CDMOs, packaging and distribution facilities. Integrate cross-functional internal and external teams across CMC, clinical operations, regulatory affairs, and quality assurance to deliver clinical trial materials. Author global clinical labels, pharmacy manuals, and clinical supplies Standard Operating Procedures. Support preparation of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers). Support Quality Assurance with implementation and management of the quality system and compliance activities, including inspections by regulatory agencies and audit functions. Education And Experience
Bachelor's degree with at least 10 years of related clinical trial supply experience with increasing responsibility in biopharmaceutical development with 7 years of supervisory/leadership experience. 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). This includes the ability to effectively and accurately present data to peers, management, and external partners. Experience with preparation of regulatory documents is desired. Excellent ability to work in a goal and team-oriented setting and to handle competing priorities. Flexibility within a rapidly changing environment and high attention to details. Well-developed organizational skills and the ability to thrive under pressure. Well-versed in industry trends, emerging business processes and technologies. Technical Knowledge Required
Must have excellent PC-based computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, Project), and IRT/RSTM Systems. Knowledge of other software: Visio. Physical Demands And Work Environment
Physical Activities: On a continuous basis, sit at a desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel
You may be required to travel for up to 20% of your time. 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. Total Compensation
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Salary Range
The salary range for this position is: $150,000 - $188,000. 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 health insurance plans for employees (and their families) including medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
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