Crinetics Pharmaceuticals

Medical Director

• Clinical leader of one or more endocrinology programs, being integral to developing the clinical strategy and plans
• Member of global project team(s) and development sub team(s)
• Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP)
• Lead the development of the Clinical Development Plan (CDP) for each indication being pursued, using the TPP as guidance
• Define the scientific rationale and design captured in the Clinical Study Outline for each study in the CDP
• Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments
• Review or oversee the review of the data input in the EDC for events of interest or needing further investigation
• Provide senior-level medical monitoring and safety oversight in cooperation with pharmacovigilance
• Collaborate with other departments in all topics related to the conduct and analysis of clinical study results
• Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings
• Support advisory boards, key opinion leader engagement, and external scientific collaborations
• Contribute to the development of relevant sections of regulatory documents such as amendments to protocols and responses to Health Authorities questions

Senior Medical Director, Clinical Research, Endocrinology

• Support the development and execution of Crinetics' endocrinology portfolio as part of a multidisciplinary development team
• Contribute to the concise clinical development plan (CCDP)
• Support the design and conduct of clinical trials across assigned therapeutic areas
• Provide medical and scientific input to publications
• Support Medical Affairs
• Help represent Crinetics to academic, regulatory, and patient organizations
• Partner with the cross-functional team to shape a concise Clinical Development Plan (CCDP) for the indication of interest, building consensus toward Executive Team approval and maintaining the plan over time
• Lead the design, planning and implementation of clinical trials consistent with this CCDP
• Provide scientific and clinical direction for the development of clinical protocols (and, in early stages, clinical trial outlines [CTOs] and synopses), amendments, and related documents (e.g., informed consent)
• Work with Medical Writing to ensure content accuracy and medical integrity
• Provide medical monitoring for clinical studies in collaboration with CRO medical monitors
• Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements
• Provide clinical and scientific input to HEOR-led Patient Reported Outcome research across the studies
• Provide medical and scientific oversight needed to support enrollment feasibility and protocol-driven eligibility
• Participate in ongoing and formal data analyses and review for CSR completion and planned/actual filing activities
• Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions
• Lead trial-related advisory boards, investigator meetings, protocol training meetings
• Collaborate with Medical Affairs and Commercial members to develop effective working relationships with key investigators, key opinion leaders and patient advocates to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
• Provide medical/clinical expertise to publications planning and drafting
• Provide oversight of clinical programs across planning, execution, and completion of clinical trials, ensuring compliance with all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs, in partnership with Clinical Operations
• Attend conferences and remain current with relevant therapeutic area information
• Serve as the external clinical "face" of Crinetics in interactions with development partners, and leading clinical discussions at advisory boards, as needed.

Medical Director, Clinical Research, Endocrinology

Clinical Operations

• Set the strategic direction for clinical science and operational execution across the endocrine clinical development portfolio
• Drive alignment across cross-functional teams to anticipate and resolve risks before they impact program timelines or quality
• Build and develop a high-performing team, including Clinical Scientists, consultants, and Clinical Research Project Coordinator
• Own clinical data oversight and ensure clean data, analysis, and interpretation
• Drive the scientific execution of through contribution of key regulatory documents
• Oversee strategic partnerships with CROs
• Identify, escalate, and drive resolution of program and portfolio risks in a timely and structured manner
• Drive continuous improvement and transformation initiatives across the Clinical Science team

Executive Director, Clinical Science, Clinical Research Operations

Director

• Develop comprehensive market research plans
• Lead the execution of various market research projects
• Lead cross-functional efforts with Marketing, Market Access, Sales, Medical Affairs, and Corporate Affairs teams
• Create global market research frameworks
• Work with partners to understand key business needs across therapeutic targets
• Align organization on research initiatives' scope, timing, and objectives
• Ensure market research conclusions are objective and supported by data
• Develop and deliver compelling presentations
• Identify qualified suppliers for market research studies and manage engagement processes
• Ensure compliance with financial and ethical guidelines

Director, Market Research

Operations

• Support the development and execution of market access strategies
• Lead all operational activities for Market Access contracts
• Collaborate with Director, Pricing and Contracting to submit accurate pricing and contracting information
• Stay up to date with federal and state laws and regulations related to Market Access
• Manage gross-to-net discount rate forecasting models and processes
• Analyze data from channel partners and third-party data/service vendors
• Maintain, execute, and update Standard Operating Procedures (SOPs) for pricing, contracting, and government reporting

Senior Manager, Pricing Operations

• Manage GLP/GCLP bioanalytical CROs and CLIA clinical testing labs
• Develop appropriate biomarker analysis strategy
• Apply fit-for-purpose biomarker validation approach
• Review and finalize method validations protocols, stability studies, and bioanalytical reports
• Participate in the periodic audit of bioanalytical CROs
• Work with cross-functional colleagues in various programs
• Manage and negotiate scopes of work, budget, and payment schedules
• Review invoices against vendor contracts
• Contribute to bioanalytical reports and regulatory documents
• Lead preparation of bioanalytical sections in regulatory submissions
• Lead bioanalytical function on written responses to health authority bioanalytical queries

Associate Director, Biomarker Analysis

Accountant

• Perform month-end, quarter-end, and year-end close activities, including journal entries, account reconciliations, and reporting schedules
• Prepare and execute cost accounting activities including standard costing, variance analysis, and inventory valuation
• Own inventory accounting processes, including balance reviews, aging analysis, and reserve assessments
• Ensure inventory accounting is aligned with company policies, including support for technical accounting analyses as needed
• Work with 3PL vendor(s) and contract manufacturing organizations (CMOs) to coordinate data gathering to support the accounting and reporting of inventory
• Maintain internal controls and support audit requirements by preparing schedules, maintaining documentation, and responding to audit requests
• Assist with revenue accounting activities as needed, including but not limited to support for closing, reconciliations, analytics, and reporting
• Identify opportunities to improve reporting and automate recurring tasks to increase accuracy and efficiency

Senior Inventory and Cost Accountant

• Lead the delivery of the real-world evidence program across the portfolio, translating evidence priorities into rigorous, well-designed real-world studies.
• Provide leadership, career management, coaching, and mentoring to a team of RWE Scientists; recruit and develop talent and align team capacity to portfolio demand.
• Drive team objectives, prioritization, and resource allocation across competing therapeutic area needs.
• Operate across long-range lifecycle planning and near-term execution horizons.
• Design and oversee burden-of-illness, natural history, patient journey, drug utilization, external control arm, comparative effectiveness, and HTA-supportive real-world studies.
• Contribute to the design and operationalization of Crinetics-sponsored registries and lead registry-related analytics and evidence generation.
• Lead analyses using large healthcare databases and primary real-world data collection methods.
• Establish methodological standards, protocol templates, statistical analysis frameworks, and quality benchmarks.
• Conduct and supervise feasibility assessments, database selection, and study-design innovation.
• Partner with IT and Commercial to shape enterprise real-world data sourcing and analytics infrastructure.
• Lead the RWE module of CrinRADAR, supporting scalable and automated evidence generation.
• Establish data governance, contracting, and vendor management standards for real-world data assets.
• Partner with HEOR Therapeutic Area Leads to translate franchise-level evidence questions into executable plans.
• Contribute evidence to integrated evidence plans, value dossiers, and HTA submissions.
• Collaborate cross-functionally with Clinical Development, Biometrics, Regulatory, and Patient Advocacy.
• Build and steward external partnerships with academic investigators, data providers, and analytics vendors.
• Lead publication strategy and external scientific communication for the real-world evidence program.
• Represent Crinetics at scientific congresses and remain current with evolving real-world evidence methodologies and guidance.
• Ensure compliance with corporate policies and applicable healthcare laws and regulations.

Senior Director, Real World Evidence – Center of Excellence Lead

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

• 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