Job description
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.
Location: Remote (EN or CH based role)
The Role:
Reporting to the Vice President, Clinical Operations-GSM, this position is responsible to drives Immunovant’s ROW clinical site oversight in conjunction with Clinical Development, Clinical Operations, Medical Affairs and the CRO partner across all Immunovant clinical trial execution in the ROW. This role also partners these groups to define overall strategy toward achieving/exceeding program specific corporate targets, identifying and mitigating potential issues, and ensuring budget and timeline compliance. The incumbent will work with Clinical Operations and Quality to ensure the monitoring oversight program is running effectively. The role also involves direct supervision and mentoring of team members that reside across the ROW in their support of the clinical sites.
Key Responsibilities:
Develop clinical site strategy for sites in the ROW including resourcing, budgeting, project plans, and oversight of sites in the ROW to achieve clinical program goals
- Will oversee the partnership with the Clinical Indications teams to collaboratively deliver program specific targets by ensuring seamless execution of team deliverables at the regional, country and site-specific levels.
- Lead a team of Immunovant ROW’ Site Relationship Managers that will assist clinical sites to ensure efficient study execution, answer questions and resolve issue
- Set strategy and lead the ROW Site Relationship Management team to execute study level recruitment plans by use of regional support group meetings and other related activities
- Lead the ROW Site Relationship Management team to support clinical sites in study execution from the Sponsor’s perspective and monitor oversight of the CRO’s CRAs. Activities include site feasibility, recommendations for selection, site start up support including SIV participation, enrollment booster activities, and ongoing logistical support to clinical sites throughout life of study.
- Per clinical site strategy recruit, hire, manage and mentor direct reports as required and support their professional development ensuring strong leadership and delivery through all levels of the team
- Partner with Patient Advocacy Director to ensure country specific plans are created to target appropriate national patient support/advocacy groups to target the ROW patient recruitment
Partner with clinical operations and clinical development to provide proactive strategic and operational input for clinical development planning and execution that enables efficient delivery of high-quality clinical outcomes.
Partner with Medical Liaison leadership to develop field-based strategy and to deliver on portfolio/clinical trial strategy at the regional/site level.
Establish and report key performance indicators related to SRM site engagement and oversight activities.
Ensure adherence to regulatory requirements (ICH, EMA, etc.) and GCP guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes. Ensure SRM adherence to the monitoring oversight plan and alignment with cross functional oversight plan, ensuring appropriate site escalations and assistance with remediations as needed.
Ensure the lead SRM PM for each indication contributes to the preparation, and finalization of clinical protocols, PIS/ICFs, IB updates with any unique regional insights needed.
Participate in RFP process and evaluation/selection process of CRO or other external vendor partners.
In alignment with the clinical indication teams, the senior director ensures execution on enrollment plan, risk mitigation, issues management and delivery of high-quality data from the ROW’ sites.
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
Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation
Within the Clinical Operations team, exhibit strong problem-solving skills and agility to adjust to changing business priorities and needs
Collaborate cross-functionally, both internally and externally, to ensure highest quality customer service for clinical sites and patients. Support the SRMs as needed to ensure the necessary escalations occur for clinical sites in the ROW that have issues with CRO performance or support.
Establish and nurture relationships with site investigators across the ROW’
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 (Biotech experience is a plus)
- 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
- Understanding of regional cultural differences in a professional context (US vs EU)
- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent.
- Understanding of clinical trial operations and management of clinical trials at investigator sites
- 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 and get in the weeds of projects as a jack of all trades
- 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
Work Environment:
- Location: Remote (EN or CH based role)
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (25%)
Salary range for posting
£200,000—£222,600 GBP
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity 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.
