Senior Director Clinical Operations

Role Summary

Senior Director, Clinical Operations leads and drives program oversight for a single asset, partnering with Clinical Development and Project Management to define strategy, manage budgets and timelines, and mentor the clinical operations team.

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 CRO/vendor selection strategy to support assigned studies, oversee contracting documentation (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage relationships to enable sourcing strategies for future studies
• Supervise and direct clinical trial activities to ensure adherence to internal SOPs and regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through KPIs/KQIs and agile process improvements
• 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 and GCP guidelines through KPIs/KQIs and process improvements
• Provide input to the drafting of governance documents, SOPs, work instructions, and other resources
• Lead or participate in initiatives for process, technology, or other continuous improvement to achieve cost-reduction, time-savings, efficiency, and quality
• Build collaborative relationships with internal stakeholders to facilitate planning and execution of clinical trials, operational strategy, risk management and mitigation, and ensure timely completion of trials and deliverables
• Collaborate cross-functionally to oversee clinical operations across site management, medical writing, legal, finance, QA, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
• Provide input to governance documents, SOPs, and other resources
• Manage clinical operations manager/assistants, including performance reviews, feedback, mentoring, coaching and staff development

Qualifications

• Bachelors in Life Sciences with advanced degree preferred
• At least 15 years in the pharmaceutical industry, with at least 10 years in a clinical leadership role on a cross-functional drug development project team; CRO/small pharma/biotech experience a plus
• PMP is a strong plus
• Experience executing complex global development programs across all phases (1-4)
• Experience leading a cross-functional team is a strong plus
• Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations
• Experience selecting and overseeing CROs/vendors
• Experience in rare disease areas and patient engagement strategies preferred
• Ability to function in a fast-paced, dynamic environment and deal with ambiguity
• Ability to develop clear action plans to deliver on company strategy and clinical development plans
• Strong interpersonal and negotiation skills
• Proven complex problem solving and decision-making skills
• Self-starter and team player with strong communication skills
• Excellent written and verbal skills; strong analytical and problem-solving skills
• Direct supervisory experience
• Commitment to delivering quality results and integrity
• Willingness to roll up your sleeves to get the job done

Work Environment

Remote-based; Immunovant’s headquarters is in NYC; dynamic, interactive, fast-paced, entrepreneurial environment; domestic or international travel required (20%).