Crinetics Pharmaceuticals

• Responsible for timeline and budget management for assigned clinical studies within Clinical Operations • Serve as a key contributor to study and program teams and partner with cross-functional stakeholders to support the successful planning, execution, and delivery of clinical trials • Develop, maintain, and manage high-quality, detailed clinical study timelines that align with program and corporate goals • Interface regularly with study teams and cross-functional stakeholders to ensure accurate coordination and visibility of key activities • Prospectively identify timeline risks, proactively communicate risks to management, internal stakeholders, and CRO partners, and support implementation of mitigation strategies • Collaborate with internal functional groups to support study milestones and overall program execution • Manage routine study status reporting, including timeline and budget dashboards and management updates • Partner with Project and Portfolio Management to update resource demand and supply information on a regular basis • Develop program scenario plans and support lifecycle management activities as needed • Develop and manage study budgets, including monthly forecasting and routine budget reviews in collaboration with Clinical Trial Operations and Finance • Facilitate and oversee cost accrual activities to ensure accurate and consistent financial reporting across Crinetics‑sponsored clinical trials • Analyze forecasted and accrued costs to produce summary views of study financial health • Partner with Finance to review accrued costs versus forecasts, investigate variances, and review overall study spend using purchase order and invoice data • Provide functional guidance and support to Associate Clinical Project Managers as needed • Other duties as assigned

Role Description The Senior Manager, Quality Assurance GCP will support the Good Clinical Practice (GCP) Quality Assurance (QA) function, and performance of GCP QA operations. The role also supports QA oversight for non-clinical laboratories, including Good Laboratory Practice (GLP). This individual will manage and oversee assigned audits, support regulatory inspections, and support the quality oversight and compliance program at Crinetics Pharmaceuticals. Essential Job Functions and Responsibilities - Manage, oversee, conduct, and report on assigned GCP and GLP qualification and routine vendor audits and others as required (internal system/process, TMF, clinical site, data, and clinical documents). - Generate and maintain annual audit programs and manage schedules. - Maintain trackers and trend audit findings / CAPAs / resolution processes across programs to identify systemic issues and drive preventive actions. - Manage and perform vendor risk assessments. - Maintain and archive QA electronic vendor files and audit documentation. - Reconcile master vendor tracker and vendor records. - Manage GCP and GLP quality agreements with vendors. - Attend vendor governance and oversight meetings. - Provide GCP guidance and feedback for research and development activities; participate in clinical study team meetings and discuss clinical study-related compliance topics. - Identify and escalate significant compliance risks to senior management. - Provide guidance and support to Trial Master File activities. - Review clinical study documents (protocols, ICFs, study plans, IB, CSR, etc.) of moderate complexity and provide feedback. - Foster a collaborative environment that supports GCP compliance and continuous improvement; identify and mitigate potential compliance risks. - Review deviations, quality issues, and CAPAs; perform investigations and root cause analysis. - Develop and maintain professional cross-functional and cross-departmental relationships. - Interpret and apply global regulations of moderate complexity. - Identify compliance gaps and develop corrections or improvements. - Support inspection-readiness activities and regulatory inspections. - Develop, modify, and execute SOPs, Work Instructions, Policies, and/or Job Aids. - Develop training materials with minimal support; administer GCP training. - Manage multiple projects simultaneously / multi-tasking. - Support other quality driven activities and initiatives. - Other duties as assigned. Qualifications - Minimum with a Bachelor’s degree and at least 12 Years of experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered). - Ability to interpret FDA, EU, ICH, and other global GCP regulations. - Previous experience conducting GCP QA audits (vendor, investigator site, internal). - Provide guidance to auditors and junior level staff; manage and supervise auditor activities and assign tasks and goals. - Knowledge working with QMS in vendor management, SOPs, internal audits, deviations, and CAPAs. - Demonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous components. - Excellent collaboration, interpersonal, verbal, and written communication skills. - Outstanding organizational, prioritization skills, with attention to detail. - Good presentation skills to both internal and external audiences. - Able to work on issues where analysis of situations or data requires conceptual thinking and in-depth knowledge. - Able to facilitate moderate to complex investigations. - Has knowledge and experience using a risk-based approach. Requirements - Experience in GLP and GVP, a plus. - Regulatory inspection experience highly desired. - Auditor certification and/or RQAP-GCP certification, a plus. Travel You may be required to travel for up to 35% 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. Salary Range The salary range for this position is: $133,000 - $166,000. 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 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.

• Execute strategy and lead implementation or system enhancement of clinical systems including Veeva Vault Clinical Suite (TMF, CTMS, Site Connect, Study Start-up), Veeva Study Training, Smartsheet, and other Clinical Operations platforms such as RBQM • Oversee and mentor the Manager, Clinical Systems and Processes, providing guidance, and supporting daily clinical systems and processes activities in alignment with leadership expectations • Serve as a primary SME on behalf of Clinical Operations for Veeva Vault Clinical Suite system configurations, architecture, and backend administration, including expert-level knowledge of the Veeva Vault Clinical Suite • Support the evaluation, piloting, and adoption of Artificial Intelligence (AI) solutions to enhance Clinical Operations efficiency, data quality, and decision-making capabilities • Support the development of an RBQM platform to enable the development of dashboards, visualizations, and tools for proactive risk identification and centralized monitoring execution across clinical studies • Lead systems integration initiatives across clinical platforms, ensuring seamless data flow, interoperability, and alignment with enterprise-wide technology strategies • Develop and execute organizational change management plans to support the successful rollout and adoption of new systems, processes, and technology solutions across internal and external stakeholder groups • Oversee system-level change control and validation activities for clinical systems in compliance with GxP, 21 CFR Part 11, and SDLC standards, including impact assessments, user acceptance testing (UAT), configuration records, and associated documentation • Support maintenance of the clinical systems product roadmap by contributing to release planning, system upgrade cycles, system health monitoring, disaster recovery testing, and identifying enhancement opportunities aligned with clinical program goals • Manage vendor relationships for clinical systems platforms, including escalation of system issues, and coordination of release planning and upgrades, in partnership with vendors and IT stakeholders • Own the design and implementation of clinical process development frameworks, ensuring scalability, compliance, and alignment with organizational goals • Partner with the Director, Clinical Systems and Processes to develop departmental policies, procedures, SOPs, and strategic plans • Oversee the development and monitoring of clinical system quality metrics and compliance reporting tools, presenting findings to senior leadership as needed • Author Clinical Systems Audit Trail Review Plans and perform Audit Trail Reviews on a periodic basis • Provide oversight and support for TMF, CTMS, and other clinical system audits and regulatory inspections • Manage system administration, study-related set-up, and user access reviews across clinical systems • Support the transfer of study-specific TMFs from external vendors to Crinetics

• Support the development of drug product formulations from early preclinical enabling studies through clinical supply for First-in-Human (FIH) trials • Contribute hands-on laboratory execution, data analysis, and technical documentation in support of formulation development for oral and/or parenteral dosage forms • Perform hands-on formulation development activities for preclinical and early clinical drug products, including FIH studies • Prepare and evaluate formulations for in vivo (PK, tox) and clinical use • Execute laboratory experiments including formulation preparation, characterization, and stability testing • Maintain accurate and well-documented experimental records in electronic laboratory notebooks (ELNs) • Support scale-up, tech transfer, and manufacturing activities for clinical supplies • Assist in preparation of protocols, reports, and CMC documentation to support regulatory submissions • Collaborate cross-functionally with analytical, DMPK, toxicology, quality, and external partners/CDMOs • Troubleshoot formulation and manufacturing challenges; propose practical solutions • Ensure compliance with internal procedures and applicable GMP/GxP requirements

• Oversee timeline, budget and accruals for the clinical studies and clinical programs within the Clinical Operations group • Develop, maintain, and manage high-quality consistent study processes and templates with cross-functional Clinical Operations peers to drive consistent and reliable clinical study outcomes • In collaboration with the Project and Portfolio Management, provide clinical program timeline and budget estimates to support annual budgets and long-range planning (LRP) • Oversee and mentor team of Clinical Project Managers as needed • Develop and oversee policies and procedures aimed to streamline Clinical Project Management process • In collaboration with Clinical Trial Operations and Project and Portfolio Management, provide input on annual planning activities to meet corporate study and program objectives • Subject Matter Expert (SME) for study and program clinical timelines and budgets • Oversee routine status reporting including study timeline and budget dashboards and management updates • Ensure teams are providing monthly milestone and timeline updates to Project and Portfolio Management for entry into corporate project management system • In collaboration with Project and Portfolio Management, develop program scenario plans and support life cycle management activities as needed, support creation and incorporation of resource demand algorithms into project management software • Oversee and streamline monthly accrual process in partnership with finance • Facilitate and oversee cost accruals by study managers to ensure accuracy • Meet with finance periodically to review accrued costs against forecasts and troubleshoot variances, and to oversee overall spend for studies & programs • Identify potential budget issues and recommend and implement solutions or corrective actions as needed • Provide program-level timeline and financial health summaries for management periodically • Other duties as assigned

• Manage and oversee quality processes for packaging, labeling, distribution, and QP oversight for clinical and commercial supplies • Perform batch record review and disposition activities for Clinical and Commercial Supplies • Coordinate and manage Quality Events (Deviations, CAPAs) with CMOs and escalate to QA management • Review and approve labeling artwork for clinical and commercial products • Partner with Clinical Trial Supply organization to develop schedule and strategy for packaging and release activities including Qualified Person (QP) oversight • Support QA team on internal and external GMP/GDP audits • Compile Quality associated metrics • Lead/support field-related activity such as complaints, Field Alerts, Recall/Withdrawal, and notification to regulatory agencies • Write and review Standard Operating Procedures • Compile metrics of Batch Disposition, deviations, CAPAs as applicable

• Serve as the key commercial point of contact for National and Regional KOLs • Identify and map all academic and community-based KOLs and help map referral patterns between KOLs in center of excellence and the community • Identify and engage with next tier KOLs: Emerging Opinion Leaders and Digital Opinion Leaders • Understand regional and KOL-specific practice patterns to better understand key areas of unmet need in Acromegaly treatment • Support and participate in regional advisory boards by leading recruitment of advisors, planning and coordination with vendors to help generate key actionable insights • Develop and manage KOL-specific engagement plans and drive advocacy for Paltusotine post-FDA approval • Engage with KOLs in generating feedback on market development activities including disease state education and brand promotional strategies and tools • Lead engagement efforts of KOLs with Crinetics leadership at various forums; KOL 1:1 meetings, conferences, etc. • Tailor national brand strategies for local market dynamics • Manage and execute regional marketing programs (e.g., non-personal promotions, local sponsorships) • Oversee the regional marketing budget • Support recruitment and development of the speaker bureau in collaboration with the commercial operations team • Help develop and drive Speaker Training efforts for branded and disease state activities • Collaborate with marketing team to develop peer-peer content including educational videos, promotional supplements and other assets needed by the regions and materials for patient events • Lead Crinetics’ presence and engagement at National, regional and local congresses and facilitate our active engagement at these events to include cross functional coordination with medical, sales and marketing colleagues • Support commercial team in developing best-in-class disease state and product training curriculum to include KOL input and participation in training activities • Provide commercial team with in-market insights on core promotional activities post-approval • Develop strong collaboration with cross-functional partners: field sales leaders, sales representatives, National Account Directors and Regional Reimbursement Directors to ensure seamless field execution of promotional activities • Drive compliant coordination with field medical affairs team to effectively support customers • Ensure materials are compliant with regulatory and legal standards • Monitor regional competitive landscape to identify opportunities and risks • Other duties as assigned

Role Description The Senior Clinical Trial Associate (CTA) is a highly skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the Senior CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the Senior CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The Senior CTA may act as a Clinical Research Associate with limited monitoring responsibilities. - Execute study activities independently according to study protocol, regulatory guidelines and operational plan. - Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures. - Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards. - Contribute to study start-up, conduct, and closeout activities including, but not limited to, create patient facing materials, draft newsletters and site memos, track study metrics and escalate issues to study team. - Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines. - Participate in vendor management activities by tracking performance and quality. - Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes. - Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.). - Assemble and distribute regulatory binders to clinical sites. - Draft trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs). - Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers. - Assist with preparation and distribution of investigator site contracts and budgets. - Schedule, set up, and minute study team and vendor meetings, as applicable. - Maintain metrics on results of study documentation reviews. - Support the review of invoices from vendors/consultants as needed. - Support the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT. - Support the planning of Investigator Meetings and/or Site and CRA trainings. - Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples). - Lead the Trial Master File activities to ensure quality and completeness for clinical projects. - Manage and perform periodic reviews and QC of the Trial Master File. - Travel as required to carry out responsibilities. - Other duties as assigned. Qualifications - Bachelor’s degree biological sciences or related discipline with a minimum of 2 years of clinical experience (an equivalent combination of experience and education may be considered). - Excellent written and verbal communication skills. - Strong PC skills (MS Word, MS Excel, MS Project). - Sound analytical and problem-solving skills. - Act with consistent sense of urgency with acute attention to detail. - Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred. - Exceptional organizational and time management skills. Physical Demands and Work Environment - On a continuous basis, sit at 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. Travel - You may be required to travel for up to 5% 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. Salary Range The salary range for this position is: $83,000 - $104,000. 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 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.

• 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 forecasting, demand planning, packaging, labeling, distribution, returns, and destruction • Ensure uninterrupted supply of investigational and comparator products to global clinical sites • Manage Interactive Response Technology (IRT) system builds, UAT testing, supply strategies and reconciliation activities • Partner closely with Clinical Operations, Manufacturing, Quality, Regulatory Affairs, Finance, and external vendors as required to ensure alignment on study timelines and deliverables • Serve as the clinical supply representative on study teams and governance forums • 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 • Work with third-party providers to develop detailed project plans and timelines for the packaging, release, and distribution of clinical supplies • Coordinate the review and approval of provider documentation (distribution instructions, label proofs, packaging specifications and methods, packaging batch records, etc.) • Plan and oversee the implementation of expiry date extensions • Coordinate the assessment of and track temperature excursions during storage, receipt, or transit to clinical sites or depots • Support the transportation and disposition of returned/unused materials, as needed • Manage activities needed to source comparators and ancillary products. Plan supply strategies, labeling and distribution activities • Support the development of Standard Operating Procedures (SOPs) and guidelines related to third-party provider management, inventory management, distribution, transportation, disposition of returned/unused materials, etc. • Support CMC team as needed • Other duties as assigned.

Role Description The Senior Director, Clinical Pharmacology will be a key member of the development team, developing clinical pharmacology strategy suitable for target product profile (TPP) and clinical development plan (CDP), leading the design, execution, interpretation and reporting of Phase 1 clinical pharmacology studies, and serve as clinical pharmacology lead on studies and project teams. The work will support projects at various stages of development thereby allowing the selected candidate to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. Essential Job Functions and Responsibilities - Develop clinical pharmacology strategy and related clinical development plan consistent with the target product profile, program goals, and the US/international regulatory guidance/guideline of small molecule therapeutics. - Collaborate with DMPK, clinical research, and CMC teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label. - Determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization. - Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis. - Contribute to the design Phase 1 clinical pharmacology studies (e.g., drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.). - Participate in the selection of Phase 1 CROs for clinical pharmacology studies. - Accountable and responsible for the analysis and interpretation of PK and PK/PD data. - Participate in preparation of clinical study protocol and report. - Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies. - Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to ensure integration of modern clinical pharmacology principles into project plans and study design. - Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expert. - Focus on both immediate/short-term (<2 Years) and long range (5 years) strategic planning to determine function objectives. - Lead, direct, manage, develop, coach/mentor, and evaluate direct reports, contributing to budget and headcount planning. - Other duties as assigned. Qualifications - Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles. - 10+ years of significant industry experience in conduct and/or oversight of clinical pharmacology function, studies, and data analysis, and a minimum of 10 years of experience in a supervisory role. 13 years of overall professional experience is required. - Familiarity with all stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects. - Demonstrated ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compounds. - Expertise/experience in multiple clinical pharmacology areas is preferred - FIH and/or Ph II/III dose selection, pediatric dose selection, drug-drug interactions, enzymology of drug metabolism, formulation bridging, bioequivalence, food-effect, exposure-QTc assessments, special population, and radiolabeled mass balance studies. - Extensive experience in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings. - Experience in working in a cross functional team/matrix environment with strong vendor management skills. - Competent in the use of PK and PK/PD Modeling software tools such as Phoenix. - Strong written, presentation, and verbal communication skills. - Critical thinker with strong problem-solving skills. - Ability to influence business leaders at all levels. Preferred - Prior experience in population PK and exposure-response analysis is a plus but not required. Physical Demands and Work Environment - On a continuous basis, sit at 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. - Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel - You may be required to travel for up to 5% 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. Salary Range The salary range for this position is: $238,000 - $297,000. 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 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.