Associate Director, Portfolio Management and Processes, SRM, Remote

An organisation is searching for an Associate Director, Portfolio Management and Processes, SRM, please see some of their job details below.

The Role:

Reporting to the Associate 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%)
  
  
  

#OTHER

#OTHER