Director, Clinical Quality Assurance (CQA)

Organizational Overview:

lmmunovant, 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 Fe receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (lgG) antibodies that cause inflammation and disease.

The Role:

lmmunovant is seeking a Director, Clinical Quality Assurance (CQA) who will lead the management of GCP quality activities in support of one or more clinical programs and trials (from Phase 1 to 4 including non-interventional studies) to drive proactive quality management, and ensure compliance with corporate policies and functional procedures, and applicable regulations for ensuring the protection of the rights, welfare, well-being, and personal data privacy of subjects, data integrity, and GCP regulatory compliance. The position will report to the Sr. Director, Clinical Quality Assurance and can be based remotely, Durham NC, or New York NY.

As the primary GCP quality point-of-contact cross-functionally for the assigned clinical program(s), the Director Clinical Quality Assurance (CQA) will be responsible for supporting clinical study teams in order to enable the goal of submission­ ready quality data, first pass approvals by competent authorities for marketing authorizations, and commercializing lmmunovant products. This individual contributor will be instrumental in integrating quality and compliance strategy and establishing useful tools in tracking and trending key quality and compliance metrics to drive continuous improvement throughout the lifecycle of the clinical development process across the clinical program portfolio at lmmunovant. This position will serve as a Quality liaison during competent authority GCP inspections at lmmunovant.

Key Responsibilities:

• Partner with the Quality and Auditing Compliance Organization in order to support study-specific Clinical Trial Quality Management Plan(s) for assigned clinical program(s) and trial(s) to ensure the execution of a phase­ appropriate, fit-for-purpose Audit Program
• Represent Quality at cross-functional clinical program meetings and Clinical Study Team meetings and operational activities to provide appropriate Quality guidance on GCP compliance matters to internal departments.
• Identify, mitigate, or escalate clinical quality risks by leveraging GCP knowledge and best practices across all phases of clinical development.
• Maintain program oversight and influence proactive quality management through quality related activities with regard to vendor management, study conduct, and study records.

• Author and/or review OMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
• Oversee the implementation of appropriate and timely
• Participate in risk review meetings and review study Risk Management
• Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Investigator Brochures, Investigator's Brochure, for ensuring quality, accuracy, and completeness
• Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues, CAPAs, and change controls
• Identify process improvements to build compliance into the design and conduct of clinical activities
• Actively support the development and deployment of Inspection Readiness/Management program to support competent authority inspections for sponsor and clinical sites & vendors

Requirements:

• A minimum of Bachelor's degree in STEM (Science, Technology, Engineering, and Math), and/or allied medical field (Nursing, Pharmacy, etc.)
• At least seven (7) years of pharmaceutical/biotech/medical device GCP Quality Assurance (QA), Quality Management or Clinical Compliance experience in Phase 1 - 4 clinical trials including non-interventional studies (experience in immunology trials is strongly preferred)
• Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety, particularly U.S. FDA/EU and ICH regulations and guidelines
• Broad and direct experience with competent authority inspections such as US FDA GCP BIMO Inspections (Sponsors, CROs, and/or Clinical Investigators), Pre-Approval Inspections (PAis), etc.
• Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations
• Comprehensive knowledge of the interrelationship among other Quality functions (CMC Quality, Quality Systems, Audit Management, Vendor Management) and other business functional areas (Biostatistics, Clinical Development, Clinical Operations, Clinical Laboratory, CMC Operations, Data Management, Drug Safety and Pharmacovigilance, Regulatory, Supply Chain, and Program Management) to serve as a good business partner

Personal Characteristics:

• Capacity to produce high quality results across multiple projects and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment

• Excellent communications skills, both written and verbal
• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally
• Strategic thinker, open-minded and flexible to adopting new ideas

Work Environment:

• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Remote based: lmmunovant's headquarters is located in New York
• Domestic and international travel required (up to 35%)

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 $210,000.00 - $220,000.00.