Director/Associate Director, Clinical Laboratories

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:

Immunovant is seeking an Associate Director / Director, Clinical Laboratories, who will be responsible for the operational oversight and management of outsourced bioanalytical (GxP) activities supporting our clinical studies. Key responsibilities include study initiation to support Central and Specialty laboratory functions, vendor management during study execution, and close-out responsibilities. This role works closely with the Senior Director, Clinical Laboratories, to support on-time seamless delivery of laboratory supplies to investigational sites, monitor sample delivery and analysis of sample analyses in support of our clinical programs.

Key Responsibilities (not limited to): 

• 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).

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 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

Work Environment:

• Remote based
• Dynamic, interactive, fast-paced, and entrepreneurial environment

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity 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 $195,000.00-$205,000.00.