VP, Clinical Research Science

The Role:

The VP, Head of Clinical Science, reporting to the Chief Medical Officer, will lead and shape a team of Clinical Research Scientists (CRSs) who are accountable for all of IMVT’s clinical studies across all phases of development. These studies will be for multiple indications across therapeutic areas. 

CRSs contribute to the design, conduct, analysis, and reporting of all IMVT clinical trials, applying scientific training and clinical research experience to support all aspects of drug development. All CRSs will report to the VP, Head of Clinical Science, but each CRS will be assigned to work with a specific clinical development team on a specific indication / study / set of studies and will take direction from those study directors.

Key Responsibilities: 

• Grow and nurture a high performing team of CRSs with accountability for managing and mentoring, ensuring proper training and compliance with internal and external policies and procedures. 
• Own and continuously improve all CRS processes, tools, systems, and best practices guidelines, and provide input into all IMVT SOPs, Work Instructions, and Templates that involve the CRS role.
• Develop, motivate, coach, and appraise the performance of all CRSs to support career progression through personal development plans.
• Build and establish a strong team spirit and positive organizational culture.
• Supervise all CRSs to manage their resource allocation across all clinical studies and internal projects to meet IMVT’s corporate objectives and priorities.
• Support the growth of technical and professional skills for the CRSs and ensure team training is conducted and properly documented.
• Ensure the quality of all CRS deliverables throughout the lifecycle of the trial, ranging from protocol development to study startup, execution, and close-out through to CSR and publications.  
• Provide support to address and resolve issues in the Clinical Development organization and identify solutions for remediation.
• Lead and support cross-functional projects across the R&D organization whenever applicable. 
• Act as a Subject Matter Expert for all operational areas that involve the CRS role and identify / execute opportunities for process improvement.
• Partner with the VPs of Clinical Development and their assigned CRSs on study-specific deliverables to understand each CRS’s performance and develop customized personal development plans for each of them.
• Partner cross-functionally with all leaders in the R&D organization (including but not limited to Clinical Operations, Regulatory Affairs, Safety, Biostatistics, Data Management, Program Management, Clinical QA, etc.) to improve the deliverables of the CRS team.
• Support audits and regulatory inspections related to clinical studies and support the creation of an audit readiness working environment (in partnership with Clinical Operations and Clinical QA).

Requirements:

• Advanced degree in Sciences (PhD, MD, or PharmD) is strongly preferred but not required. Advanced MS degree with experience will be considered.
• 15+ years of clinical trial experience in the pharmaceutical industry with significant experience in a Clinical Research Scientist or equivalent role.
• Experience building and managing high-performing clinical development teams.
• Experience improving and simplifying processes in pharmaceutical or biotech companies.
• Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols
• Understanding of Health Authority requirements and ability to participate in Health Authority inspections as required

Work Environment:

• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Immunovant’ s headquarters is located in New York City. The position is remote based.
• Domestic travel required (up to 10%)