Senior Director - Clinical Quality Assurance

March 13

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Immunovant

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Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

Biotechnology Research

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. • Immunovant is seeking a Senior Director, Clinical Quality Assurance (CQA) to serve as a key leader in Quality on a highly dynamic, cross-functional team. • The position reports to the Senior Vice President & Head of Quality with responsibility for leading Clinical Quality Assurance (CQA). • This individual will have the unique opportunity to help grow and shape the quality team, quality systems and clinical processes. • The Senior Director, Clinical Quality Assurance (CQA) provides global GCP oversight and direction for Immunovant Clinical Operations. • This role also provides strategic planning for continuous improvement efforts, reporting/escalation of critical quality issues, conducting risk mitigation for clinical trial activities and ensuring a compliant culture of quality. • This position will contribute to Immunovant’s success by managing all clinical quality assurance activities under the guidance of the Head of Quality. • The Senior Director will also participate in strategic planning with a focus on meeting corporate quality goals.

🎯 Requirements

• Bachelor or Master’s degree in Biology, Chemistry, Nursing, or related fields. • A minimum of eight (8) years of GCP experience with a focus on quality with substantial operational and clinical quality assurance experience. • A minimum of five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; a minimum of two (2) years managing Phase 1-3 clinical trials. • A minimum of three (3) years supervising and managing people and teams. • Experience interacting with FDA, EMA and other global health authorities. • Experience with building a GCxP culture in a start-up biotechnology company preferred throughout a company. • Experience in immunology with clinical trials is strongly preferred. • Strong analytical and organizational skills, with attention to detail. • Excellent written, verbal, listening and interpersonal communication skills. • Ability to professionally interface with all levels (e.g. senior-level executives, staff, colleagues, external partners, consultants). • Integrated Quality leader with ability to build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance. • Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment. • Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity and discretion at all times.

🏖️ Benefits

• Equity and other forms of compensation may be provided as part of a total compensation package. • Full range of medical, dental, vision, and 401k benefits. • Unlimited paid time off and parental leave.