Immunovant is a clinical stage biopharmaceutical company committed to developing innovative therapies for autoimmune diseases. Our lead asset, IMVT-1401, is in phase 2 clinical development for several indications.
Immunovant is seeking a Director, Clinical Laboratories to play a key role on a highly dynamic cross-functional team. In this role, you will be responsible for directing the work of contract laboratories to develop and execute disease and program specific clinical assays for our clinical programs. The individual in this position will have the unique opportunity to participate in the rapid-growth of a biotech startup.
- Lead a group of scientists at a contract laboratory for biomarker method development, validation and sample analysis in the regulated environment (GLP or CLIA).
- Manage all the biomarker projects to ensure the quality, timeline and deliverable are met for each project.
- Provide strong technical support to the contract laboratory on different biomarker platforms. Ability to trouble-shoot and solve technical and instrumental issues.
- Review bioanalytical documentation that includes study protocols, analysis plans, data packages, validation study reports and sample analysis reports.
- Act as the main point of contact for biomarker projects, discuss the projects with the clinical teams, and provide timely communication and updates.
- Ensure high-quality laboratory procedures, documentation and GLP / CLIA compliance.
- Write and update SOPs and ensure utilization of GLP and CLIA compliant biomarker laboratories.
- Partner with the development team to develop strategy and manage clinical laboratory needs, which will become increasingly important as we move forward into Phase 3.
- PhD in Biology or Chemistry, or related field with experience managing a group of scientists or a contract laboratory
- 5+ years of experience at a pharma, biotech, or clinical laboratory
- Hands-on experience in developing ligand binding assays, cell-based assays, biomarker analysis and instrumentation such as MSD, Simoa, Luminex, etc.
- Strong experience and knowledge of method development / validation for supporting regulated studies
- Excellent communication and interpersonal skills and project management skills.
- Demonstrated ability to manage teams and diverse sets of stakeholders
- Multitasking ability to oversee a large number of projects and reach milestones on time
- Exceptional academic and professional accomplishments, indicating critical thinking ability
- Strong project management skills with a proven track record of success
- 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
- Ability to think outside of the box and challenge the status quo
- Natural entrepreneurial spirit with unrelenting dedication to delivering results
- Desire to work in a fast-paced, innovative environment
- Natural collaborator who enjoys working on a cross-functional team
- The position will be located in Immunovant’s NYC office
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (~10%)