Crinetics Pharmaceuticals

Clinical Research

• Manage execution of clinical studies and data collection
• Provide oversight of clinical research studies across all functional areas of drug development
• Develop subject recruitment/retention strategy and related initiatives
• Oversight of TMF setup, ongoing quality review, and final reconciliation of study documents
• Develop training materials for study team, investigational sites, and vendors
• Proactive management of information sharing with key stakeholders
• Ensure compliance with ICH/GCP and other regulations
• Collaborate with counsel to negotiate and draft research contracts and agreements
• Perform study risk management and implement mitigations
• Create realistic plans that define goals, milestones, responsibilities, and results
• Manage daily activities and development of direct reports

Clinical Trial Manager

Project Manager

• report to the Director, CMC Operations
• support CMC leadership in the development and execution of operational plans
• provide project management support to CMC team leads for key programs
• facilitate development of and maintain adherence to project plans and timelines for key CMC activities
• ensure alignment between CMC objectives and overall corporate strategy
• liaise with project team members within CMC and across functions (including Quality and Regulatory) to drive successful completion of project deliverables
• collaborate with Clinical Trials Supplies (CTS) to ensure production activities for Investigational Product (IP) meets clinical demand needs and associated timing
• support in the preparation and review of regulatory filings, including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers
• maintain executive project dashboards, working in close collaboration with other members of the CMC team responsible for API, DP, ARD/QC, and CTS
• other duties as assigned.

Manager, Project Management CMC

Medical Director

• build and execute the Medical Affairs (MA) team’s evidence generation, education, and KOL engagement assuring strategic alignment across multiple functional areas at Crinetics (commercial, compliance, legal, etc.) within our acromegaly indication
• lead initiatives and deliver business results, set annual goals, develop and refine plans, policies and procedures while maintaining excellence in standards and practices
• facilitate the collaboration with key opinion leaders and drive scientific engagement with health care practitioners, research groups, payers, and patient advocacy groups throughout the company
• co-develop and implement the Medical Affairs strategic and integrated medical plans across their lead asset
• identify data gaps and develop and deliver an integrated evidence generation plan
• provide scientific guidance and tactical execution for medical publication planning, medical education, medical information system development, field medical liaisons, medical communication, RWE, and HEOR
• develop and maintain professional relationships with Key Opinion Leaders (physicians and researchers) and relevant professional societies
• contribute to the conduct of scientific advisory boards and steering committees and partner with new product planning in executing subject matter expert focus groups
• support preparation of clinical sections of relevant regulatory filings and safety reporting in conjunction with the Executive Medical Director, Medical Affairs
• provide medical review of training materials for medical and commercial employees; contribute to scientific affairs by authorizing and/or reviewing abstracts, presentations and manuscripts for medical and scientific accuracy and content .

Senior Medical Director, Medical Affairs Asset Lead

Director

• Develop clinical pharmacology strategy and related clinical development plan
• Collaborate with DMPK, clinical research, and CMC teams to define studies needed to support an NDA and drug label
• Determine scope, design, plan, and analyze phase 1-4 studies
• Provide clinical pharmacology expertise to project teams
• Contribute to the design of Phase 1 clinical pharmacology studies
• Participate in the selection of Phase 1 CROs for studies
• Accountable 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 regulatory documents
• Serve as the primary Clinical Pharmacology Lead in cross functional teams
• Represent clinical pharmacology at regulatory meetings

Senior Director, Clinical Pharmacology

• Provide clinical expertise and scientific insights to help monitor, track, and analyze subjects’ data in phase 1 - 3 studies
• Collaborate with the Medical Lead and groups involved in Clinical Development such as Pharmacokinetics, Clinical operations, Biometrics, Pharmacovigilance, and Medical Affairs
• Monitor, analyze, and review safety and efficacy data for events of interest
• Review laboratory parameters, patient profiles, data listings, summary tables
• Collaborate with clinical leads and medical directors on scientific content and program strategy
• Support authoring and review of various clinical and regulatory documents
• Address scientific and protocol related issues from investigators
• Contribute to safety narratives, manuscripts, and scientific presentations
• Support preparation for safety review committees
• Review protocol deviations to identify cause and resolution
• Participate in Database lock activities and represent CR at internal meetings
• Contribute to the development of regulatory documents in collaboration with Medical Affairs and Patient Advocacy
• Participate in research site identification and relationship building with CROs

Senior Clinical Scientist

• responsible for 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
• serve as clinical pharmacology lead on studies and project teams
• support projects at various stages of development thereby allowing the selected candidate to play an active role in drug discovery and development efforts
• contribute to 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 and clinical research 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
• champion model-informed drug development (MIDD)
• plan, prepare, and review drug development plans and regulatory filings
• 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 (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, etc.)
• participate in the selection of Phase 1 CROs for clinical pharmacology studies
• be accountable and responsible for the analysis and interpretation of PK and PK/PD data
• participate in preparation of clinical study protocol and report
• prepare clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.)
• respond to regulatory requests for information (RFIs)
• serve as the primary Clinical Pharmacology Lead

Associate Director, Clinical Pharmacology

Compliance

• support regulatory strategy implementation for development programs
• lead and prepare regulatory submissions (authoring, timeline planning, etc.)
• assist in developing and implementing global regulatory strategies
• establish and maintain department regulatory processes
• develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required
• actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed
• contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization
• lead the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications
• coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments as needed
• develop and manage project timelines for regulatory submissions
• maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission
• provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages
• track submissions, correspondence, and commitments with health authorities
• provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional
• provide regulatory intelligence and research to the team as needed
• write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate
• lead, direct, manage, coach/mentor, and evaluate direct reports

Associate Director, Regulatory Affairs CMC

• Lead and mentor the Clinical Scientist team (including consultants), reviewing their work and supporting their professional development.
• Serve as a scientific liaison between clinical research with multiple departments including clinical operations, regulatory, biostatistics, pharmacovigilance, and medical affairs, ensuring consistency in the clinical development approach across the organization.
• Support data cleaning and analyses of clinical studies to enable high quality medical decision making, presentations at internal and external meetings, manuscripts and regulatory documents.
• Support the Medical Leads and Medical Monitors in clinical data reviews to identify events of special interest that require further investigations.
• Collaborate with Medical Monitors, biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications, abnormal lab, etc).
• Perform and supervise systematic evaluation of clinical data for multiple projects in terms of data quality and trend analysis in ongoing clinical trials.
• Participate in periodic Medical Review meetings along with the Medical Leads.
• Contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings.
• Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions.
• Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents.
• Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans.
• Support Clinical Operations, CROs, and site staff on study protocol related questions Support preparations for safety review committees, DSMBs/DMC incl. data review and development of presentations.
• Collaborate with Medical Leads to support effective working relationships with key investigators, and key opinion leaders.
• Participate in research site identification and relationship building with CROs in this space.
• Other duties as assigned.

Senior Director, Clinical Science

• 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)
• Focus on immediate and short-term (<2 years) strategic planning horizon
• 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
• Conceive and write 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 on a regular basis the data input in the EDC for events of interest or needing further investigation and all reports generated from ongoing clinical studies
• Provide senior‑level medical monitoring and safety oversight in cooperation with pharmacovigilance
• Collaborate with other departments (Biometrics, Clinical Operations, Medical Affairs, a.o.) in all topics related to the conduct and analysis of clinical study results
• Guide interpretation of clinical data
• 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, briefing books, safety updates, responses to Health Authorities questions

Senior Medical Director

Manager

• Execute and oversee centralized monitoring activities across clinical trials using a risk-based quality management (RBQM) framework
• Perform ongoing centralized monitoring reviews using clinical, operational, and quality data sources
• Identify emerging study-level and site-level risks through Key Risk Indicators (KRIs)
• Support the evaluation of trends, data anomalies, and protocol deviations
• Document and report signals, findings, and recommendations within designated systems
• Collaborate with Clinical Monitoring to support alignment of monitoring approaches with ICH-GCP E6 (R2/R3) and internal SOPs
• Support oversight of centralized monitoring vendors, tools, or platforms
• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials

Associate Manager, Centralized Monitoring

QA Engineer

• Perform batch record review, and disposition related activities for Clinical and Commercial Supplies
• Coordinate and manage Quality Events (Deviations, CAPAs) with CMOs and escalate them to QA management
• Oversee QA Packaging / Labeling Operations and distribution for Crinetics products
• Review and approve labeling artwork for clinical and commercial product
• Partner with Clinical Trial Supply organization to develop schedule and strategy for packaging and release activities including Qualified Person (QP) oversight
• Represent QA in internal and external team meetings
• Support QA team on internal and external GMP/GDP audits
• Support QA management on compiling Quality associated metrics
• Lead / Support QA management on field related activity such as complaints, Field Alerts, Recall / Withdrawal, and notification to regulatory agencies
• Perform impact assessment and disposition for supplies that are subjected to temperature excursion
• Write and review Standard Operating Procedures
• Write and approve internal investigations, as applicable
• Compile metrics of Batch Disposition, deviations, CAPAs, as applicable
• Supports GMP QA operations and overall QMS processes, as appropriate.
• Other duties as assigned.

Senior Manager, Supply Chain Quality Assurance

• support the Good Clinical Practice (GCP) Quality Assurance (QA) function
• perform day-to-day GCP QA operations
• execute and/or ensure proper oversight of GCP QA activities
• perform external and internal audits
• support clinical phase 1 to phase 4 study team activities
• review documents
• support regulatory inspections
• enhance GCP QA infrastructure development
• manage or perform clinical site, internal, TMF, GCP, and GLP vendor audits
• generate and/or review GCP and GLP QA audit plans and schedules
• generate and/or review and approve audit trend reports across programs
• communicate, address, and prevent identified GCP compliance issues and trends
• develop and manage audit programs
• represent QA at program-wide meetings
• serve as point of escalation for GCP compliance issues
• embed Quality ‑ by ‑ Design (QbD) and Critical ‑ to ‑ Quality (CtQ) principles into study planning and execution
• investigate, manage, and track GCP CAPAs, deviations, and other quality issues
• collaborate with cross-functional teams
• assist with serious breach assessments and notifications
• provide guidance and support to Trial Master File activities
• review study-specific documents
• partner with cross-functional groups and promote compliance
• attend governance meetings
• identify and address quality systems gaps
• author, review, or revise SOPs, Work Instructions, Policies, and Job Aids
• deliver training to internal and external stakeholders
• support regulatory inspections and inspection readiness activities
• prepare clinical sites for inspection readiness
• draft and recommend Quality Agreements for GCP/GLP vendors
• direct/supervise personnel; including coaching, mentoring, development, and performance management

Associate Director, Quality Assurance, GCP

• Develop and implement strategies to protect Crinetics’ intellectual property
• Manage patent prosecution in-house and by outside counsel
• Identify commercially valuable IP in collaboration with teams
• Manage prosecution of high-quality patent applications
• Conduct and manage freedom-to-operate and patentability analyses
• Review and assist in negotiating IP provisions of agreements
• Provide coaching and mentoring to direct reports

Senior Director, Intellectual Property

Financial Planning and Analysis

• Lead and own commercial financial forecasting processes, including revenue, gross‑to‑net, demand planning assumptions, and commercial performance modeling, ensuring alignment across key cross‑functional partners
• Oversee commercial operating expense planning, partnering closely with commercial leadership to ensure financial discipline, optimized resource allocation, and alignment with corporate objectives
• Serve as the primary strategic finance partner to commercial leaders, providing insights and recommendations that support product launch readiness, market planning, and commercial execution strategies
• Analyze and communicate monthly and quarterly commercial performance, identifying trends, risks, and opportunities, and presenting clear recommendations to executive leadership
• Conduct ROI analyses for sales, marketing, and market access initiatives to ensure capital deployment supports commercial effectiveness and product performance
• Drive consistency in forecasting methodologies, assumptions, and reporting across Commercial, Accounting, NPP, and S&OP
• Lead the recurring commercial purchase order review process, enforcing financial controls and ensuring well‑supported and value‑driven investments
• Partner with Commercial, NPP, S&OP, and Accounting to ensure pricing strategies, demand expectations, accruals, and revenue recognition processes are aligned and financially sound
• Support long‑range planning through scenario modeling, sensitivity analysis, and evaluation of commercial strategies
• Promote continuous improvement across commercial FP&A processes to enhance accuracy, efficiency, and collaboration

Associate Director, Commercial FP&A

Content Writer

• Ensure company compliance with clinical trial transparency laws and requirements by applying expert knowledge of key regulatory frameworks, including FDAA 801 and Final Rule and CTR 536/2014
• Work with cross-functional teams to develop content for clinical trial and results postings and post all approved materials in accordance with regulations
• Develop and implement internal procedures, processes, templates, and tools for all aspects of clinical trial disclosure
• Develop and maintains CCI documents (process owner)
• Prepare redacted documents for postings ensuring CCI and personal protected information (PPI) in accordance with the General Data Protection Regulation in the EU and other privacy laws are identified for redaction and redacted from documents that are posted publicly
• Apply logic, attention to detail, critical thinking, good judgement, and follow-up skills to every deliverable and situation
• Approach all engagements with cross-functional team members with a customer-service mindset
• Other duties as assigned