CrawlJobs Logo

Director, IRT Systems

kailera.com Logo

Kailera Therapeutics

Location Icon

Location:
United States , Waltham

Category Icon
Category:
IT - Administration

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

196000.00 - 240000.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

The Director, IRT Systems will be responsible for the initiation, execution, maintenance and close out of IRT systems throughout Kailera’s portfolio. This position will track and maintain timelines for all Go Live and Close Out activities, adhere to all GxP requirements as well as maintain and organize all required documents for filings. This position will be unblinded, and part of the Global Supply Chain department, reporting to the Senior Director, Global Supply Chain.

Job Responsibility:

  • Liaison between Global Supply Chain and Business Operations to gather requirements and timing for quotes through go live dates
  • Expert in interpreting protocols and study schemes to ensure IRT builds are properly quoted and executed
  • IRT system design and overnight including management of study drug kit lists (Dummy and Live)
  • Collaborates cross functionally with clinical development, clinical operations, CMC, and statistics, focusing on randomization schema, stratification, and site & subject management, to ensure all requirements across the groups are met within the system
  • Vendor management: Serves as primary contact for IRT vendors internally and escalates requests and support as needed
  • Leads project documentation, test scripts, eTMF filing and performance metrics from study start to closeout for company portfolio
  • Risk management and continuous improvement to ensure IRT is performing as needed
  • Supports day to day activities for ad hoc resolutions, process optimizations and enhancements as needed
  • Actively participates in clinical study meetings, provide updates on system functionality and provides training as needed
  • Proactively reviews requirements to identify potential risks and build risk mitigation strategies
  • All other duties as required

Requirements:

  • 10+ years of experience managing end-to-end activities for IRT system builds and close outs
  • Ability to interpret clinical protocols and provide system-based solutions for IRT optimization
  • Profound knowledge of various drug presentations and formulations
  • Excellent project management and organizational skills
  • Excellent communication skills and ability to present and articulate system needs clearly and effectively
  • Successful management and deployment of kit list builds (Dummy and Live) across Ph I – Ph III clinical studies for both open label and blinded needs
  • Ability to work cross-functionally and prioritize activities while maintaining all requisite timelines for study needs
  • Thrive in a fast-paced environment
  • Passion for continuous improvement and innovation to bring study drug to patients quickly and effectively
  • Bachelor's degree or equivalent experience

Nice to have:

  • Worked with complex study designs including up/down titrations across various drug product formulations
  • Successfully manage IRT build and closeout of clinical studies across 3+ IRT systems
  • Advanced degree or PharmD
What we offer:
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • equity grants

Additional Information:

Job Posted:
February 03, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Icon
Kailera Therapeutics - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Director, IRT Systems

Director, Global Supply Chain

The Director, Global Supply Chain reports to the Senior Director, Global Supply ...
Location
Location
United States , Waltham, MA or San Diego, CA
Salary
Salary:
175000.00 - 230000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
  • 8+ years of experience in clinical supply management
  • Experience with global pharmaceutical development and manufacturing operations for development-stage and/or commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
  • Deep understanding of IRT systems
  • Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
  • Strong computer skills including MS Office
  • Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
  • Ability to think outside of the box and challenge the status quo
  • Desire to work in a fast-paced, innovative environment
  • Domestic or international travel is required (up to 20%)
Job Responsibility
Job Responsibility
  • Managing drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
  • Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
  • Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
  • Providing day-to-day oversight of packaging and labeling/distribution vendors, including relationship management
  • Contributing to the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
  • Proactively identify potential issues, notify management in a timely manner, and develop mitigating actions
  • Interpret clinical synopses and protocols to create clinical IMP demand forecasts
  • Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
  • Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
  • Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
What we offer
What we offer
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • a year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • Fulltime
Read More
Arrow Right

Director, Psychometric Operations & Data Governance

Join College Board as the Director of Psychometric Operations & Data Governance,...
Location
Location
United States , San Juan
Salary
Salary:
64000.00 - 80000.00 USD / Year
edtechjobs.io Logo
EdTech Jobs
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in Data Science, Computer Science, Statistics, Information Systems, Psychometrics, or related field
  • 8–12+ years of experience in data architecture, governance, analytics leadership, or high-stakes operational data environments
  • Demonstrated experience owning production data systems with strict accuracy and compliance requirements
  • Proven track record implementing data governance frameworks and automation strategies
  • Strong technical fluency in SQL and at least one programming language (R or Python)
  • Experience designing or operating data workflows within AWS cloud infrastructure and working with structured and semi-structured data formats (e.g., JSON)
  • Working knowledge of IRT and CTT models, scaling, and equating procedures
  • Experience deploying AI/ML models into operational workflows
  • Strong executive communication and stakeholder alignment skills
  • Ability to travel 1-2 times a year to College Board offices or on behalf of College Board business
Job Responsibility
Job Responsibility
  • Psychometric Operations Leadership (30%): Drive and safeguard the operational integrity of scoring, equating, calibration, and reporting data workflows
  • Execute and monitor scoring cycles meet defined turnaround time, accuracy, and QA standards
  • Design and implement reproducibility, documentation, and traceability standards across all psychometric processes
  • Architect and implement modernization of legacy scoring and item analysis pipelines into relational or warehouse-based systems
  • Conduct root-cause analysis for systemic scoring irregularities or data discrepancies
  • Partner with Psychometricians to ensure form rotation, scaling, and calibration processes are technically sound and operationally resilient
  • Enterprise Data Governance & Stewardship (25%): Serve as the designated Data Steward for psychometric and operational data within CB-LATAM
  • Design and operationalize a unified governance framework covering metadata, retention, access control, and data lifecycle management
  • Maintain comprehensive end-to-end data flow documentation across systems
  • Ensure compliance with College Board governance policies, professional testing standards (AERA/APA/NCME), and applicable privacy regulations
  • Fulltime
Read More
Arrow Right
New

Ikea food

In the restaurant area, we ensure that our customers have several options, incre...
Location
Location
Portugal , Almancil, Faro
Salary
Salary:
Not provided
https://www.ikea.com Logo
IKEA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • I like working in restaurants, in a team in a dynamic and collaborative way
  • I like customer contact and the desire to offer a good service that gives our customers a reason to return to IKEA more often
  • Ability to manage stress, sense of responsibility and ability to establish priorities and organize one's work efficiently
  • Flexible and receptive approach to change, with a proactive and entrepreneurial spirit, looking for new ways of doing things and improving the customer experience
Job Responsibility
Job Responsibility
  • Ensure a clean, organized and inviting work space
  • Work in the kitchen preparing and cooking dishes
  • Provide service in the customer restaurant, actively approaching the customer
  • Work in the co-workers restaurant
  • Work in the Bistro preparing delicacies and providing customer service
  • Work in the Swedish Grocery store providing customer service and managing the sales space
  • Contribute to safety, efficiency and good operational practices in accordance with current routines and food safety standards (HACCP)
What we offer
What we offer
  • Co-workers Restaurant with diverse and healthy options at an affordable price
  • Schedules communicated in advance
  • Social and psychological support through the CÖNTIGO program
  • Annual bonus
  • Discounts and benefits in partnerships: gyms, technology, cosmetics, hotels, travel, etc.
  • Opportunities for ongoing online, in-class and on-the-job training
  • Parttime
Read More
Arrow Right
New

Sales associate

The sales associate plays a key role in achieving high standards. You will be wo...
Location
Location
Netherlands , Amstelveen
Salary
Salary:
Not provided
calvinklein.us Logo
Calvin Klein
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience within hospitality/retail
  • Good communication skills with the ability to build relationships easily
  • Team player who recognizes and celebrates the contributions and achievements of others
  • Ability to handle change, adapt quickly, and work with pace
  • Energetic and authentic with a clear presence on the shop floor
  • Approach problems with a 'can do' attitude and act with initiative to find solutions in the store
  • Hardworking
  • Interest in Fashion/Retail
  • Ability to work in a fast paced environment with ability to multi task in high pressure environments
  • Passionate to drive sales using digital platforms
Job Responsibility
Job Responsibility
  • Ensure high customer satisfaction through excellent service
  • First point of contact for authorizing discounts and resolving customer questions
  • Be a brand ambassador with in-depth product knowledge
  • Build and maintain professional relationships with customers
  • Put together outfits for customers and make further product recommendations
  • Assess customer needs and provide help and information on product features
  • Drive store KPIs and suggest improvements
  • Ensure shop and stock room maintenance, presentation and organization issues are addressed appropriately
  • Demonstrate in-depth product knowledge and possess successful link selling skills to drive business
  • Hold the ability to outfit build for customers
What we offer
What we offer
  • Competitive and comprehensive benefits program that offers protection, peace of mind and flexibility
  • Commitment to fostering an inclusive and diverse community of associates with a strong sense of belonging
  • Parttime
Read More
Arrow Right
New

Software Engineer

You will lead the development and delivery of web-based solutions that directly ...
Location
Location
France , Bidart
Salary
Salary:
Not provided
sophiagenetics.com Logo
SOPHiA GENETICS
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2-3 years’ experience in the software engineering field
  • Bachelor’s degree in Computer Science or Engineering or equivalent professional experience
  • demonstrated experience in developing reliable web-based services and have a firm grasp on the underlying challenges of releasing web components to production
  • solid proficiency of front-end framework: React, Next JS, Node, JSX
  • proficiency in Java for back-end development
  • solid understanding of backend technologies and microservices architecture
  • experience with databases like MySQL, MariaDB, and DuckDB
  • experience with AI use in SDLC
  • familiarity with Linux environments and GitLab for version control and CI/CD pipelines
  • good knowledge of software engineering best-practices, Agile, CI/CD, testing frameworks, TDD, BDD
Job Responsibility
Job Responsibility
  • Develop and optimize web-based services and components, leveraging modern frameworks (React, Next.js, Node.js) and robust backend technologies (Java, microservices) to deliver seamless user experiences
  • Own and drive the full lifecycle of complex, high-performance software systems - from design and implementation to testing, deployment, and maintenance - ensuring reliability and scalability
  • Enhance system performance through database optimization (MySQL, MariaDB, DuckDB) and efficient query design, ensuring data integrity and fast processing
  • Leverage AI and modern tools to enhance SDLC, observability, monitoring, and system intelligence, driving data-driven decision-making
  • Orchestrate cross-functional projects by collaborating with Product, QA, Architecture, and other teams to design interoperable systems and deliver high-impact features
  • Lead code reviews and mentor junior engineers, fostering a culture of quality, innovation, and continuous improvement
  • Resolve complex technical issues with efficiency, minimizing downtime and ensuring smooth operations
  • Streamline SDLC processes, integrating Agile, CI/CD, and DevOps tools (Docker, Kubernetes, GitLab) to accelerate delivery and improve workflow automation
  • Collaborate with stakeholders (PMO, Product, QA, Architecture) to align technical execution with product vision and user needs
  • Bridge technical execution with business goals by deeply understanding the genomics and digital healthcare domain, ensuring solutions align with user needs and regulatory requirements
What we offer
What we offer
  • Health benefits for you and your family covered by 80% employer contributions
  • Life Insurance and pensions contribution
  • SWILE meal vouchers and home office allowances
  • Fulltime
Read More
Arrow Right
New

Regional finance associate

We are seeking a high-potential Finance Associate to be groomed for future manag...
Location
Location
Malaysia , Kuala Lumpur
Salary
Salary:
6000.00 - 9000.00 MYR / Month
https://www.randstad.com Logo
Randstad
Expiration Date
May 02, 2026
Flip Icon
Requirements
Requirements
  • Degree in Accounting, Business Administration, or an equivalent professional qualification
  • 3 – 5 years of accounting experience
  • External audit exposure in fund accounting, private equity, or fund management (preference)
  • Strong foundation in Singapore Financial Reporting Standards (FRS) and IRAS regulations (significant advantage)
  • Proficiency in Microsoft Office
  • Experience with NetSuite or similar ERP systems (bonus)
  • Proactive problem-solver with a passion for process improvement
  • Ability to prioritize and perform under tight timelines with minimal supervision
  • Excellent communication skills and high attention to detail
Job Responsibility
Job Responsibility
  • Independently manage the full set of accounts for assigned entities, encompassing monthly closing, reconciliations, and supporting schedules
  • Execute core accounting functions including cash management, payment operations, and payroll processing
  • Determine Net Asset Values (NAVs), calculate fund performance, and ensure the accuracy of fund accounting records
  • Prepare and analyze financial and operational reports to facilitate management decision-making
  • Lead the coordination of annual external audits across multiple entities and funds, ensuring all schedules and documentation are complete and accurate
  • Prepare and submit quarterly GST filings and manage local tax matters with relevant authorities
  • Assist in the preparation of statutory forms, reports, and surveys required by the Monetary Authority of Singapore (MAS)
  • Ensure compliance with statutory regulations and internal financial controls
  • Manage relationships with professional service providers, including fund administrators, banks, tax agents, corporate secretaries, and auditors
  • Support the distribution of returns to existing investors, including the drafting of necessary documentation
Read More
Arrow Right
New

Assistant Front Office Manager

Assists the Front Office Manager in administering front office functions and sup...
Location
Location
United States , Maui
Salary
Salary:
72000.00 - 95000.00 USD / Year
https://www.marriott.com Logo
Marriott Bonvoy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or GED
  • 2 years experience in the guest services, front desk, or related professional area
  • OR 2-year degree from an accredited university in Hotel and Restaurant Management, Hospitality, Business Administration, or related major
  • no work experience required
Job Responsibility
Job Responsibility
  • Assists the Front Office Manager in administering front office functions and supervising staff on a daily basis
  • Utilizes interpersonal and communication skills to lead, influence, and encourage others
  • advocates sound financial/business decision making
  • demonstrates honesty/integrity
  • leads by example
  • Encourages and builds mutual trust, respect, and cooperation among team members
  • Supervises and manages employees
  • Managing all day-to-day operations
  • Understanding employee positions well enough to perform duties in employees' absence
  • Ensures employee recognition is taking place on all shifts
  • Fulltime
Read More
Arrow Right
New

VP Sales - Insurtech

An innovative and fast-growing insurtech operating at the forefront of digital t...
Location
Location
United Kingdom , London
Salary
Salary:
120000.00 GBP / Year
calibrecandidates.com Logo
Calibre Candidates
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven track record of SaaS sales success within Insurance and London Market clients
  • Strong focus within Property & Casualty (P&C) insurance
  • Entrepreneurial mindset with a proactive, self-starting approach
  • Demonstrated ability to build and leverage a strong industry network
  • Credible communicator with the ability to engage C-suite stakeholders
  • Commercially astute with a strategic approach to business development
Job Responsibility
Job Responsibility
  • Drive new business sales across London Market (insurers, brokers, MGAs)
  • Build and execute a strategic sales plan aligned with company growth targets
  • Develop and maintain a strong network of senior industry contacts
  • Identify and convert new opportunities within Property & Casualty (P&C) lines
  • Collaborate with product and leadership teams to refine market proposition
  • Represent the business at industry events, conferences, and regular client meetings
  • Lead complex sales cycles from origination through to close
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy