Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.

The Role:

Reporting to the Senior Director, Clinical Laboratories, this position is responsible for sponsor oversight of outsourced bioanalytical (GxP) activities at Central / Specialty laboratories that are supporting Immunovant clinical studies. The individual in this role will ensure timely delivery of laboratory supplies to investigator sites and the subsequent analysis of biological samples defined in study protocols. In addition, this role works closely with internal project teams to communicate and resolve any laboratory related issues.

Key Responsibilities: 

• Oversight of 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.
• 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.
• Oversight of specialty laboratories that validate bioanalytical methods and perform sample analysis for pharmacokinetic, pharmacodynamic, anti-drug antibody, and non-routine biomarker 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.
• 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.
• Contribute to regulated clinical trial documents (e.g., study protocols).

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.

Beneficial Experience:

• 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.

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.