Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
Immunovant is seeking a Vice President, Clinical Operations and Innovation, to play a key role in delivering high-quality clinical results across multiple indications in the IMVT-1401 program. The individual in this position will have the unique opportunity to grow and shape the IMVT-1401 clinical team at a rapidly growing biotechnology company. In addition, this individual will develop a new clinical innovation team within the clinical organization to ensure Immunovant is on the cutting edge of clinical innovation.
This position will contribute to Immunovant’s success by leading the clinical operations activities while working closely with other functional area leads at Immunovant and third-party CROs and vendors.
Summary of Key Responsibilities:
Provide strategic and operational leadership across multiple clinical programs, including clinical operations strategy, risk management, compliance with regulatory guidelines, and investigation and implementation of novel clinical approaches.
This role will ensure that corporate scorecard objectives are met, identify and resolve program/cross-program level issues and risks, and maintain process and quality expectations.
- Cross-indication management of clinical trials, including scope, timelines, quality, risk management, and budgets with adequate governance processes
- Serve as the point of contact for senior management and Operations Leads across indications, including preparation of clinical content for the Board of Directors meetings, regulatory submissions, and financial disclosures
- Participate in developing the overarching strategy for the Clinical Development and Operations, including Sponsor Oversight and Governance for key CROs and other vendors
- Develop and implement enterprise-level standardizations where appropriate while retaining a level of flexibility that allows for speed of execution and creative innovations
- Participate in developing and managing the long-range plan for the Clinical Development and Operations that anticipates future needs (resources and technology) and maximizes the team’s ability to work efficiently while delivering high quality, customer-focused solutions to increase Immunovant’s competitive advantage
- Co-own all aspects of the Quality System related to the Clinical Operations with Quality Unit oversight, including drafting and maintaining SOPs and driving quality improvements
- Actively monitor progress on the functional-level scorecard that aligns to the R&D research goals and priorities, including leading indicator metrics that monitor results against the approved plan
- Develop the resourcing strategy for the team, including management of hiring, performance management, and succession planning of direct reports
- Create and resource a new clinical innovation team within Clinical Operations to enable new approaches to clinical research and also develop improved clinical processes to ensure high quality and increased efficiency in clinical trial planning and execution
- Build relationships with our external partners to supplement internal staffing
- Ensure effective external partnerships with study sites, investigators, KOLs, pharma trade associations, and alliance partnerships
- Cultivate effective relationships with health authorities to ensure the successful outcomes of inspections
- Bachelor’s degree or higher within life sciences plus a minimum of 10 years Clinical Operations Management in Pharmaceutical/Biotech industry
- Proven record of implementing Project Management processes, methodologies, practices, and infrastructure, as related to the Biopharmaceutical Industry
- Proven project management experience in the planning, conduct, and management of clinical programs (Phase I-post-marketing)
- Demonstrated ability to effectively communicate with and influence individuals at all levels of the organization, including conflict resolution, problem-solving, and crisis management.
- In-depth knowledge of Drug Development with strong understanding of other functions relevant to the position, which include: Nonclinical, Manufacturing, Commercial and Regulatory
- Direct experience in managing projects to registration and launch
- Experience interfacing with regulatory agencies (e.g., FDA, EMA)
- Previous supervisory and leadership experience
- In-depth understanding of GCP, ICH Guidelines and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook, Project)
- Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
- Demonstrated communication, problem-solving, and negotiation/decision-making skill
- Ability to think outside of the box and challenge the status quo
- Natural entrepreneurial spirit with unrelenting dedication to delivering results
- Desire to work in a fast-paced, innovative environment
- Natural collaborator who enjoys working on a cross-functional team
- Knowledge of GDPR is a strong plus
- Strong analytical and organizational skills
- Excellent written, verbal, and interpersonal communication skills
- Ability to professionally interface with senior-level executives, staff, external partners, and consultants
- Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
- Ability to take initiative, prioritize and execute tasks and special projects with minimal direction or supervision, maintaining a high level of confidentiality, integrity, and discretion at all times
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work.
- Dynamic, interactive, fast-paced and entrepreneurial environment
- Travel requirements: approximately 30% (both national and international)