Immunovant · 2 months ago
Senior Director, Clinical Operations
United States
Full-time
Onsite
Director/Executive
$275K/yr - $285K/yr
15+ years expImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Senior Director, Clinical Operations leads program oversight for a single asset, partnering with Clinical Development and Project Management to define strategy, manage budgets, and ensure compliance with regulatory requirements. This role also involves supervision and mentoring of clinical operations team members.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
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
Qualification
Required
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. Experience working at a CRO, small pharma or biotech company is a plus
Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations is required
Experience selecting and oversight of CROs/vendors required
Ability to function in a fast pace, dynamic environment
Ability to deal with ambiguity
Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
Strong interpersonal and negotiation skills
Proven complex problem solving and decision-making skills
Must be a demonstrated self-starter and team player with strong interpersonal and communication skills
Excellent written and verbal skills
Must display strong analytical and problem-solving skills
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
Preferred
Advanced degree preferred
PMP is a strong plus
Experience executing complex global development programs across all phases of clinical research (Phases 1-4)
Experience leading a cross functional team is a strong plus
Experience in rare disease therapeutic areas and patient engagement strategies preferred
Benefits
Equity and other forms of compensation may be provided as part of a total compensation package
Full range of medical, dental, vision, 401k, and other benefits
Unlimited paid time off
Parental leave
Company
Immunovant
Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.86BKey Investors
Roivant Sciences
2025-12-11Post Ipo Equity· $550M
2025-01-13Post Ipo Equity· $450M
2023-09-27Post Ipo Equity· $450M
Leadership Team
Melanie Gloria
Chief Operating Officer
Recent News
2026-01-11
MarketScreener
2026-01-05
Company data provided by crunchbase