Director, Clinical Laboratories

Summary

Join Immunovant, a clinical-stage immunology company, as their Director, Clinical Laboratories. You will oversee outsourced bioanalytical (GxP) activities supporting clinical studies, from study initiation to close-out. Key responsibilities include vendor management, sample analysis monitoring, and ensuring compliance with regulations. This role requires close collaboration with cross-functional teams and strong leadership skills. The position is remote-based and offers a competitive salary, equity, and a comprehensive benefits package including unlimited paid time off and parental leave. The ideal candidate possesses a Master's degree or PhD in a scientific field and extensive experience in clinical trials and laboratory management.

Requirements

• Master’s degree or PhD in a scientific field and/or appropriate experience
• Solid understanding of drug development; Phase 1-3 clinical program experience
• Ability to comprehend laboratory requirements and methodology and ensure vendors are adhering to regulatory requirements
• Experience with cross functional collaborations and the ability to present data/conclusions and lead scientific teams remotely
• Multitasking ability to oversee multiple projects and reach milestones on time
• Strong written and oral communication skills with incredible attention to detail
• Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades
• Natural collaborator, great interpersonal skills and team player who enjoys working on a cross-functional team

Responsibilities

• Oversight with Central Laboratories including: Reviewer and signatory for regulated documents provided to laboratories to permit the collection, processing, shipment, and analysis of biological samples from clinical trial participants
• Protocol and amendment review for assessment of laboratory impact against program timelines
• Troubleshoot preanalytical, analytical, and postanalytical issues that impact sample analysis
• Facilitate and lead periodic vendor meetings
• Participate and monitor third-party laboratory system version updates
• Foster partnerships with laboratories via standing meetings and on-site visits
• Designated business owner for study contracting
• Partner with data management to ensure appropriate laboratory details in compliance with data transfers
• Participate in the selection and onboarding of new vendors
• Functional area lead for quality-lead site audits
• Functional area lead for eTMF management
• Provide laboratory timelines to key stakeholders
• Participate in site-activation/initiation meetings and/or visits
• Ensure laboratory-specific details are incorporated in documentation per regulatory requirements
• Participate in laboratory governance meetings
• Facilitate ongoing review of processes to provide continuous improvement recommendations
• Manage small team responsible for daily activities at third-party laboratories
• Review and oversight of specialty laboratories that validate bioanalytical methods and perform sample analysis for pharmacokinetic, pharmacodynamic, and anti-drug antibody studies. Conduct periodic meetings
• Review validation and sample analysis plans
• Review and interpret validation data and ensure compliance to regulations
• Manage timelines and logistics for the delivery of PK, PD, ADA, and biomarker data
• Work closely with Immunovant cross-functional project teams to provide technical input on laboratory procedures. (functional area details included above) Participate in periodic Team meetings and provide laboratory updates
• Investigate isolated analytical/logistical issues that could impact participant enrollment
• Identify trends that may require Clinical Labs intervention to improve efficiencies
• Contribute to regulated clinical trial documents (e.g., study protocols)

Preferred Qualifications

• Assay Development experience at pharma, biotech or clinical laboratories
• Clinical trial laboratory start-up, oversight and closeout experience
• Hands-on experience and knowledge of method development / validation for supporting regulated studies; GLP and GCLP/CLIA experience a plus
• Contributions to regulatory documents in support of drug development programs
• Experience with biotherapeutic drug development

Benefits

• Medical
• Dental
• Vision
• 401k
• Unlimited paid time off
• Parental leave
• Equity