Director, Clinical Operations

Role Summary

The Director, Clinical Operations leads and drives program oversight in conjunction with Clinical Development and Project Management (PM) and across other functional areas for an indication’s life cycle. This role also partners with Clinical Development 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 may involve direct supervision and mentoring of clinical operations team members.

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
• 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 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

Qualifications

• Bachelors 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
• Experience in rare disease therapeutic areas and patient engagement strategies preferred
• 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

Work Environment

• Remote-based; Immunovant‚Äôs headquarters is in NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (20%)