Intel Corporation is hiring a
Director, Clinical Laboratories

Summary

The job is for a Laboratory Oversight Manager at Immunovant Inc., a clinical-stage biopharmaceutical company. The role involves overseeing outsourced bioanalytical activities, ensuring timely delivery of laboratory supplies, and analyzing biological samples. The position requires a Master’s degree or PhD in a scientific field and/or appropriate experience, solid understanding of drug development, ability to comprehend laboratory requirements and methodology, multitasking abilities, strong communication skills, and interpersonal skills.

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 of Central Laboratories
• Oversight of Specialty Laboratories
• Review and sign regulated documents for laboratories
• Protocol and amendment review for laboratory impact assessment
• Troubleshoot preanalytical, analytical, and postanalytical issues
• Participate in third-party laboratory system version updates
• Foster partnerships with laboratories via standing meetings and on-site visits
• 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
• 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
• Ensure labs have available investigational products and critical reagents to support Immunovant studies
• Work closely with Immunovant cross-functional project teams to provide technical input on laboratory procedures
• 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

Preferred Qualifications

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

Benefits

• Work Environment: Immunovant’s headquarters is in New York City. The position is flexible for remote work
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic and international travel is required (~10%)
• Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave
• The annual base salary for this position ranges from $190,000.00 - $210,000.00