Associate Director, Portfolio Management and Processes, SRM
Organizational Overview:
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.
The Role:
Reporting to the Director, Portfolio Management and Processes, SRM, this position is responsible for driving and collaborating with Immunovant’s Sponsor Team, CRO Study team/sub-teams, SRM Directors, SRMs and MSLs to drive trial delivery to plan for their assigned trial(s) and/or indication(s). This role also partners with these groups to define strategy toward achieving/exceeding trial-specific corporate targets, identifying and mitigating potential issues, and ensuring timeline compliance.
Key Responsibilities:
- Collaborate with Sponsor and CRO Study Teams/sub-teams, local SRMs and local MSLs to drive trial delivery to plan.
- Coordinate and ensure Site Management’s responsibilities between Study Teams and SRMs (feasibility, site selection, site activation, enrolment, site/trial closure, issue escalation, site visit planning).
- Ensure sufficient training in trial protocol/processes for SRMs.
- Assist the clinical indication teams in the creation of clinical plans and trial feasibility by facilitating efforts to incorporate regional/local needs as needed
- Monitor and track trial level delivery of enrollment and milestones per trial level plans set by the clinical indication team and communication of results
- Facilitate Site Management and cross functional process development and implementation to enable delivery of portfolio; create library and mechanisms for sharing best practices
- Build collaborative relationships with key internal stakeholders to facilitate the planning, and execution of clinical trials, operational strategy, risk management and mitigation
- Provide input to trial level risks captured by the clinical indication team, report any new risks detected and support mitigations as needed across regions
- Serve as escalation point for clinical teams that have issues with clinical trial site-based deliverables
Requirements:
- Bachelors in Life Sciences with an advanced degree preferred
- At least 8 years of experience in the pharmaceutical industry, with at least 5 years in a clinical role on a cross-functional drug development project team
- Global experience working across all phases of clinical research (Phases 1-4)
- Demonstrated ability to manage cross functional teams and diverse set of stakeholders
- Multi-tasking ability to oversee many projects and reach milestones on time
- Strong project management skills with proven track record of success using project management tools
- Working knowledge of ICH and GCP regulations is required
- 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
- Unrelenting dedication to delivering quality results
- Influencing without authority
- 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
- Natural collaborator who enjoys working on a cross-functional team
Work Environment:
- Remote-based
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)
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. The annual base salary for this position ranges from $170,000.00 - $180,000.00.
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