Associate Director, Clinical Operations

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as an Associate Director, Clinical Operations. Lead and oversee the execution of clinical trials, collaborating with various departments throughout the trial lifecycle. Partner with senior leadership to define strategies, mitigate issues, and ensure budget and timeline adherence. Supervise and mentor team members, ensuring compliance with regulations and internal SOPs. Contribute to protocol design, report preparation, and operational document finalization. Build strong relationships with internal stakeholders to facilitate trial planning and execution. This remote-based role requires domestic and international travel.

Requirements

• Bachelor's in Life Sciences with an advanced degree preferred
• 6-8 years of clinical research experience within a pharma, biotech or CRO, with at least 4 years leading a cross-functional drug development project team
• 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
• Contribute to the CRO/vendor selection strategy to support assigned studies, collaborate with Procurement on the documentation for contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies
• Escalate to VP or Sr. Director Clinical Operations as needed
• 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
• May 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
• May provide input to the drafting of governance documents, SOPs, work instructions, and other resources
• May manage clinical operations assistants, including effective performance reviews, feedback, and development of staff

Preferred Qualifications

Experience in rare disease therapeutic areas and patient engagement strategies preferred

Benefits

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