Crinetics Pharmaceuticals

QA Engineer

• Lead the administration and day-to-day execution of the GMP Quality Risk Management (QRM) program across GMP quality, development and commercial operations.
• Facilitate structured risk assessments (e.g., FMEA, risk ranking/filtering) with cross-functional SMEs to ensure consistent identification, categorization, and quantification of risk.
• Partner with Technical Operations project teams to embed risk-based decision making into: Product development lifecycle, Technology transfer, Process validation and continued process verification, Manufacturing and supply chain activities.
• Ensure risks are appropriately documented, trended, escalated, and maintained through their full lifecycle within QMS tools.
• Establish and maintain risk registers, dashboards, and metrics to provide visibility into risk profiles and trends.
• Drive alignment between QRM outputs and core quality systems (e.g., deviations, CAPA, change control).
• Serve as the Quality Engineering representative on project teams or facilitate structured touchpoints with project leads to ensure integration of QRM principles.

Senior Manager, Quality Engineering

Clinical Research

• Provide clinical expertise and scientific insights for Clinical Development Program
• Conduct data analyses to support decision making and create presentation slides
• Perform clinical data reviews and collaborate with various clinical development groups
• Lead Medical Review meetings and contribute to regulatory documents
• Collaborate in cross-functional meetings and support Clinical Operations

Clinical Scientist

Manager

• Execute and own external data management activities for assigned clinical studies
• Develop and maintain Data Transfer Agreements (DTAs) and external data specifications
• Coordinate and perform test data transfers with hands-on QC
• Import, validate, and reconcile external datasets
• Collaborate with Clinical Operations, Biostatistics, and Regulatory teams
• Support regulatory inspections as the external data management subject matter expert

Senior Manager, Clinical Data Management – External Data Management

• 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

Senior Manager, Clinical Systems and Processes

Clinical Operations

• 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

Clinical Project Manager

Research Analyst

• 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

Senior Research Associate, Drug Product Development

Project Manager

• 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

Associate Director – Clinical Project Management

Marketing

• 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

Director, Regional Marketing

• 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.

Senior Manager, Clinical Trial Supplies

Business Operations

• Develop, negotiate and execute site budgets and ensure consistency among sites with multiple Crinetics’ studies
• Close collaboration with global CRO partners on site budget template development and negotiation function for Crinetics
• Oversee compliance with internal financial policies/SOPs, ICH-GCP compliance, and FMV regulations
• Track site budget metrics to measure performance (e.g., start-up timeline acceleration and negotiated cost savings) and drive process improvement
• Develop and cultivate strong internal cross-departmental and external relationships
• Collaborate cross-functionally with Legal, Finance, and Clinical Operations
• Identify risks and mitigation strategies
• Other duties as assigned

Manager, Clinical Business Operations

Accountant

• Support month-end close process, including data entry, reconciliation of sub-ledgers to the general ledger, and maintenance of balance sheet account reconciliations
• Prepare G&A, and select R&D accruals, including maintaining trackers, coordination with functional leaders and analyzing other accruals for accuracy and completeness
• Assist with operationalizing contract terms
• Manage prepaid reconciliations, including subscriptions, insurance and other prepaid accounts
• Oversee fixed asset accounting including additions, disposals, depreciation, and execution of the annual fixed asset inventory
• Prepare and record payroll‑related journal entries
• Utilize and efficiently operate the accounting modules of the company’s accounting system and related financial systems
• Prepare audit schedules and analyses
• Ensure adherence to established policies and procedures, and internal controls to maintain compliance with Sarbanes Oxley (SOX) requirements
• Participate in process improvements, system enhancements, and documentation efforts

Senior Accountant

Program Manager

• Provide senior PM leadership and strategic oversight for one or more drug development programs, ensuring cross-functional alignment, coordinated planning, and on-time delivery of key milestones across the oncology pipeline.
• Serve as a strategic partner to the Program Global Product Leader (GPL), proactively anticipating program needs, identifying strategic options, and designing scalable, efficient team processes and operating rhythms.
• Own and drive the integrated program plan, critical path, and scenario analyses; lead program teams through complex planning exercises including regulatory submissions, clinical milestones, and portfolio-level decision points.
• Organize and facilitate Global Product Team and key sub-team/working group meetings, including agendas, attendee management, minutes, decisions, and action items.
• Accurately and efficiently maintain and track detailed integrated timelines, milestones, and deliverables across all components of program plans (e.g., clinical, regulatory, CMC, nonclinical, clinical operations, biometrics, safety, medical writing, clinical pharmacology, quality, translational/biomarkers).
• Facilitate identification of key dependencies, risks, and issues; drive mitigation strategies, decision support, escalation, and contingency planning at both program and portfolio levels.
• Maintain dashboards and reporting mechanisms for program status, risks, decisions, and critical path updates for team and senior/executive leadership.
• Facilitate cross-functional communications to gather inputs, align priorities, resolve conflicts, and share project updates; ensure clarity of owners, deliverables, and deadlines.
• Maintain an integrated program calendar identifying critical decision points, governance reviews, team events, and key milestones.
• Partner with Portfolio Management to ensure appropriate integration with overall portfolio strategy, timelines, and reporting, including alignment between development activities and portfolio-level planning.
• Lead preparation for governance reviews and executive program presentations, ensuring materials are accurate, aligned, decision-oriented, and delivered on schedule.
• Drive disciplined change control and documentation of scope/timeline changes, ensuring impacts are understood and communicated to stakeholders.
• Champion consistency of PM practices, tools, and reporting within the broader PPM team; lead the development and continuous improvement of PM tools, templates, and best practices.
• Contribute to PPM organizational development, including mentoring junior PM staff and supporting onboarding of new team members.
• Lead or support additional PPM or enterprise projects from initiation through closeout, including stakeholder alignment, risk/issue management, and status reporting.
• Manage both immediate execution needs and medium-term (2–3 year) strategic planning horizon while building scalable mechanisms that extend to future portfolio needs.

Director, Program Management

Product Manager

• Lead cross-functional Global Product Team(s), partnering with the Project Manager and functional leaders from development, regulatory, CMC, operations, commercial and other business functions.
• Have clear ownership of progressing the program forward and be the primary point of contact for the CEO and executive leadership on strategy, risks and execution progress.
• Contribute to corporate strategic initiatives including portfolio-level strategy for entry and expansion into oncology and contribution to other oncology programs at Crinetics.
• Accountable for building strategic and coordinated product development plans, aligned with program vision, business objectives and key results and are differentiated from competitor products.
• To include creation and integration of clinical development plans, lifecycle strategies and regulatory submissions.
• Drive the team to out-of-box thinking, effectively run/mitigate/communicate risk, make decisions, and handle conflict and change.
• Challenge assumptions, timelines and expenses at program level, pressure tests plans, create alternative scenarios to enable strategic and operational agility.
• Manage prioritization of program team activities to enhance program value.
• Drive team objective and goal setting, prioritization, and adherence to plan and strategy.
• Lead and communicate the product development strategy at governance meetings, accountable for aligning with executive leadership and for communicating with external collaborators.
• Partner with functional heads across all key product development areas, including Discovery, Development, Regulatory, CMC, and Commercial, to ensure strategic alignment and achievement of program deliverables.
• Responsible for maintaining a high degree of GPT effectiveness through collaboration, influence, and, as necessary, coaching and mentoring of cross-functional team members.
• Maintain strong industry awareness and knowledge to ensure that product plans reflect current scientific/medical developments and regulatory/commercial environment.
• Support execution of company sponsored publication plans to ensure timely production of manuscripts and other communication tools.
• Ensure presentations and other product communications are clear and effective.
• Ensure Product and Sub-team readiness for regulatory filings and commercial launch readiness.
• Contribute to corporate strategic initiatives including portfolio-level strategy discussions.
• Other duties as assigned.