Senior Director, Clinical Operations

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

The Senior Director, Clinical Operations leads and drives program oversight in conjunction with Clinical Development and Project Management (PM) for an indication’s life cycle for a single asset. This role also partners with Clinical Development and PM to define overall strategy toward achieving/exceeding program specific corporate targets, identifying and mitigating potential issues, and ensuring budget and timeline compliance. Additionally, the role serves as an escalation point and resolution resource for operational issues and decision gates. Lastly, the role will involve direct supervision and mentoring of clinical operations team members.

Key Responsibilities:

• Contributes to program strategy, resourcing, budgeting, project plans, and oversight for clinical studies to achieve clinical program goals
• Guides and supports trial management activities including budget management, study management, CRO/Service Provider oversight, risk mitigation and Good Clinical Practices
• Leads the CRO/vendor selection strategy to support assigned studies, oversee the documentation for contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies
• Supervise and direct clinical trial activities to ensure adherence to internal SOPs, as well as adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes
• Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents.
• Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes
• Provide input to the drafting of governance documents, SOPs, work instructions, and other resources
• Leads and/or participates in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality or other business objectives
• Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation and oversees appropriate progress and timely completion of trials and deliverables according to established milestones and goals
• Collaborate cross-functionally to oversee the clinical operations aspects of work processes involving site management, medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
• Provide input to the drafting of governance documents, SOPs, work instructions, and other
• Manage clinical operations manager/assistants, including effective performance reviews, feedback, mentoring, coaching and development of staff

Requirements:

• Bachelors in Life Sciences with an advanced degree preferred
• At least 15 years of experience in the pharmaceutical industry, with at least 10 years in a clinical leadership role on a cross-functional drug development project team. Experience working at a CRO, small pharma or biotech company is a plus.
• PMP is a strong plus.
• Experience executing complex global development programs across all phases of clinical research (Phases 1-4)
• Experience leading a cross functional team is a strong plus
• Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations is required
• Experience selecting and oversight of CROs/vendors required
• Experience in rare disease therapeutic areas and patient engagement strategies preferred
• Ability to function in a fast pace, dynamic environment
• Ability to deal with ambiguity
• Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
• Strong interpersonal and negotiation skills
• Proven complex problem solving and decision-making skills
• Must be a demonstrated self-starter and team player with strong interpersonal and communication skills
• Excellent written and verbal skills
• Must displ