Director, Clinical Operations

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as the Director, Clinical Operations. Lead and drive program oversight across various functional areas for an indication’s life cycle. Partner with Clinical Development to define strategies, identify and mitigate issues, and ensure budget and timeline compliance. Serve as an escalation point for operational issues. Directly supervise and mentor clinical operations team members. Contribute to program strategy, resourcing, budgeting, and project plans. Oversee trial management activities, including CRO/vendor selection and oversight.

Requirements

• Bachelor's in Life Sciences with an advanced degree preferred
• At least 12 years of experience in the pharmaceutical industry, with at least 8 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
• Global experience working across all phases of clinical research (Phases 1-4)
• Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations is required
• Experience selecting and oversight of CROs/vendors required
• Direct supervisory experience
• 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 display strong analytical and problem-solving skills
• Unrelenting dedication to delivering quality results
• Integrity, in word and action
• Willingness to roll up your sleeves to get the job done

Responsibilities

• Contribute to program strategy, resourcing, budgeting, project plans, and oversight for clinical studies to achieve clinical program goals
• Guide and support trial management activities, including budget management, study management, CRO/Service Provider oversight, risk mitigation, and Good Clinical Practices
• Lead 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 the 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
• Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management, and mitigation
• 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 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
• Manage clinical operations manager/assistants, including effective performance reviews, feedback, and development of staff

Preferred Qualifications

Experience in rare disease therapeutic areas and patient engagement strategies preferred

Benefits

• Remote-based; Immunovant’s headquarters is in NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (20%)
• Salary range for posting $215,000 — $225,000 USD
• Equity and other forms of compensation may be provided as part of a total compensation package
• Full range of medical, dental, vision, 401k, and other benefits
• Unlimited paid time off
• Parental leave