Immunovant

Clinical Operations

• 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

Director, Clinical Operations

Manager

• Interacts with Contract Research Organizations (CROs) involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables.
• Able to produce timely statistical analyses of clinical and related data analysis per protocols and SAPs.
• Able to develop statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results.
• Participates in the development and maintenance of internal SAS macro library and safety database.
• Provides statistical input for Statistical Analysis Plans (SAPs), publication activities, scientific presentations and promotional material.
• Participates in the review of Case Report Forms (CRFs), CRF annotations, SAPs, and TLGs shells and TLGs.
• Participates in study team meetings as a representative of the statistical programming function.
• Communicates statistical issues and acts as a statistical/programming resource to the development teams.
• Participates in the assessment, selection and evaluation of CROs.
• Able to create/review derived dataset specifications and the related analysis datasets.
• Able to develop training guidelines related to statistical programming.

Senior Manager, Statistical Programming

• 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
• Leads 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.
• 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
• 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 and oversees appropriate progress and timely completion of trials and deliverables according to established milestones and goals
• 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
• Manage clinical operations manager/assistants, including effective performance reviews, feedback, mentoring, coaching and development of staff

Senior Director, Clinical Operations

Threat Intelligence Specialist

• Track industry trends and competitor performance
• Review, aggregate, analyze and monitor pharmaceutical development databases and market research reports
• Build and maintain an intelligence database
• Generate ad-hoc reports, presentations and data visualizations synthesizing the competitive landscape

Competitive Intelligence Analyst

QA Engineer

• Provide quality oversight of laboratory activities for analytical testing and ensure compliance with global GxP regulations
• Provide leadership and oversight of GMP testing at CMOs and contract testing laboratories
• Vendor oversight, review and approval of method validation, method transfer and stability documents, primary raw data review, exceptions management (deviations, CAPAs, OOS/OOT), and change control
• Work closely with CMC Manufacturing, Quality Control, CMC QA, and CMC Regulatory Affairs to manage testing laboratory deliverables and timelines
• Ensure regulatory compliance with FDA, EMA, ROW, and other global health authority requirements related to laboratory testing
• Participate in strategic planning to meet corporate quality goals and promote a culture of quality across the company
• Participate in regulatory inspections and third-party audits as needed
• Review and approve sampling instructions, test methods, specifications, stability protocols, and QC procedures
• Drive product quality through virtual Quality systems, supplier oversight, surveillance and KPI collection

Senior Scientist, Laboratory QA

Director

• Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, randomization plans
• Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers
• Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory)
• Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards
• Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports
• Oversight statistics and programming vendors
• Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making
• Remote-based; access to Immunovant’s NYC and North Carolina offices available
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel may be required (<10%)

Director, Clinical Operations

Senior Manager, Statistical Programming

Senior Director, Clinical Operations

Competitive Intelligence Analyst

Senior Scientist, Laboratory QA

Associate Director, Biostatistics