Address
Form of workOrganizational Overview:
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 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 team members.
Key Responsibilities:
• Contribute to program strategy, resourcing, budgeting, project plans, and oversight for clinical studies to achieve clinical program goals
• 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
• 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
• Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents
• 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
• Manage Clinical Operations manager/assistants, including effective performance reviews, feedback and development of staff
• Collaborate cross-functionally to oversee the Clinical Operations aspects of work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
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
• PMP is a strong plus
• Global experience working across all phases of clinical research (Phases 1-4)
• Working knowledge of ICH and GCP 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
• 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's headquarters is in NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (20%)
Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $213021-295830
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 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 team members.
Key Responsibilities:
• Contribute to program strategy, resourcing, budgeting, project plans, and oversight for clinical studies to achieve clinical program goals
• 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
• 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
• Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents
• 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
• Manage Clinical Operations manager/assistants, including effective performance reviews, feedback and development of staff
• Collaborate cross-functionally to oversee the Clinical Operations aspects of work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
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
• PMP is a strong plus
• Global experience working across all phases of clinical research (Phases 1-4)
• Working knowledge of ICH and GCP 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
• 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's headquarters is in NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (20%)
Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $213021-295830
