Clinical Laboratory Director
2 weeks ago
We are seeking a seasoned Clinical Laboratory Director to join our team at Immunovant, Inc. As a key member of our clinical development group, you will be responsible for the operational oversight and management of outsourced bioanalytical activities supporting our clinical studies.
Key Responsibilities:- Oversight of Central Laboratories including reviewer and signatory responsibilities for regulated documents, protocol review, troubleshooting analytical issues, and vendor management.
- Facilitating periodic vendor meetings, participating in third-party laboratory system version updates, fostering partnerships with laboratories through regular meetings and on-site visits.
- Designated business owner for study contracting, partnering with data management to ensure compliance with data transfers, participating in site-activation/initiation meetings and/or visits.
- Ensuring laboratory-specific details are incorporated in documentation per regulatory requirements, participating in laboratory governance meetings, facilitating ongoing process reviews for continuous improvement recommendations.
- Managing a small team responsible for daily activities at third-party laboratories, reviewing and interpreting validation data to ensure compliance to regulations, managing timelines and logistics for the delivery of PK, PD, ADA, and biomarker data.
Immunovant is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. We are leaders in FcRn inhibitor technology and are boldly developing innovative therapies for debilitating autoimmune diseases with significant unmet patient needs.
Requirements:- Masters or PhD in a scientific field and/or relevant experience.
- Solid understanding of drug development, Phase 1-3 clinical program experience.
- Ability to comprehend laboratory requirements and methodology, ensuring vendors adhere to regulatory requirements.
- Experience with cross-functional collaborations, presenting data/conclusions, and leading scientific teams remotely.
- Multitasking ability to oversee multiple projects and meet milestones on time.
- Strong written and oral communication skills with attention to detail.
- Natural collaborator with excellent interpersonal skills and a team player who enjoys working on a cross-functional team.
Competitive salary range: $195,000 - $205,000 per year, based on location, knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package. Benefits include medical, dental, vision, 401k, and unlimited paid time off, parental leave, and more.
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