Regional Head CRMA EU

Summary

The Regional Head CRMA EU designs and provides oversight of clinical research programs. Builds relationships with key opinion leaders and applies their input to enhance study design and protocols. They serve as medical/scientific consultant to marketing or research project teams and government regulatory agencies and establishes the criterion essential for determining the safety, efficacy, and medical utilities. Interprets results of Phase I‑III investigations in preparation for new‑drug or medical device application.

The successful candidate will provide leadership for a team of CRMAs and CRMA Country Heads (30 – 120 FTEs), set consistent performance standards and drive global integration along with accelerate Global Drug Development and selected trials in terms of timelines and quality of clinical feasibility, site selection/initiation, recruitment and data quality.

You will drive innovation in clinical execution with a focus on data and new digital technologies and supports innovative study designs for pivotal registration studies and new recruitment initiatives by exploring existing Real World Evidence Data, and manage framework for interfacing and collaboration with partnering functions.

Office

Location:

London (The Westworks), United Kingdom or Dublin, Ireland. Hybrid (12 days per month on‑site if living within 50 miles of our London office). Remote (if living beyond 50 miles of our London office).

• Accountable for CRMAs to deliver high quality clinical feasibility for Development and selected   PoC trials; nominates CRMAs to the global feasibility team, drives clinical/medical feasibility process and outcome improvement.
• Accountable for co‑ordinating cross‑CPO/Regional initiatives to support recruitment for GDD studies, liaising between the CRMAs and the global team including innovative recruitment initiatives e.g. use of external datasets to identify patients, building referral networks, using social media.
• Support Development vision to develop innovative development plans who change the world by sharing early insights from sites, regional/local guidelines, patients and payers in partnership with medical affairs to get insights about evidence generation gaps.
• Provide Clinical Development leadership to develop and execute innovative, patient‑friendly and competitive clinical trial concept sheets/protocols by supporting Global Head CRMA to nominate CRMAs to GCTs / CTTs as needed and other global/regional working groups and ensures high quality feedback.
• Perform CRMA activities to cover potential resource gaps.
• Set guidance for CRMAs how to coach Medical Affairs colleagues to ensure a smooth transition (share ongoing activities / new data and enable excellence in local Phase 4 studies).
• Drive change management activities to facilitate acceptance of new endpoints including digital endpoints, biomarkers, etc.
• Support clinical trials using external datasets.
• Driving trial site performance and providing superior customer experience for investigators / site study teams, significantly impacting the external visibility and reputation of Novartis.
• Uses advanced influencing skills to manage collaboration between regional/local Development and Medical Affairs, balancing diverging objectives.
• Ensures strong line management to CRMA Country/Cluster Heads.
• Accountable to implement global clinical standards for CRMAs incl. details on Roles and Responsibilities and capabilities; drives consistent implementation in countries.
• Set targets and objectives, provides development feedback and evaluates performance. Supports development and implements criteria for CRMA performance assessments.
• Ensure the development and implementation of the global training strategy and on‑boarding plans within the Region taking the global guidance document into account. Monitors compliance to SOPs and required training.
• Lead regional talent management for the CRMA population, career mapping / development and succession planning activities, providing a talent pipeline for the global CD organization.
• Foster best practice sharing within and across the regions and builds a CRMA…