Study & Site Operations- US Country Head (Remote)

Role Summary

The SSO Country Head is accountable for all country clinical operations activities related to allocation, initiation, conduct and timely completion of Phase I–IV oncology and pharma trials. They implement the Study & Site Operations archetype and Hub/Country strategy, delivering to country budget and productivity targets in line with Study & Site Operations and local business objectives. They build a high-performing team culture and standardize processes across development units, including talent development, performance management and training aligned with GCP, ICH and local regulations. Location: Remote (US); travel approximately 25%.

Responsibilities

• Defines and drives Country Study & Site Operations strategy to achieve hub/country business and trial objectives in close collaboration with Americas Hub Head and US Medical.
• Aligns country SSO objectives to global and hub SSO objectives and US Medical.
• Identifies and implements innovative practices and patient engagement strategies in collaboration with CRMA, US Medical within the Country, as well as, in support of Hub strategies – to best advance clinical trial planning, execution and quality.
• In collaboration with the US SSO Country Head Portfolio, defines and implements Country feasibility strategy to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I–IV).
• Identifies opportunities to build competitive advantage for global development trials within the Country by identifying trial level synergies for medical standard of care, local business drivers and site relationship management.
• Drives collaborative engagement model with the SSO Country Head Portfolio to ensure Country participation in global trials meets GDD needs while ensuring alignment with Country/Hub strategy.
• Ensures Country site activation, enrolment, timelines, resource allocation and budget trial commitments are delivered per established Hub/Country key performance indicators.
• Actively monitors the KQIs and the development, maintenance and execution of the yearly process control plan in the Country to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements.
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
• In collaboration with US SSO Field Head responsible for country monitoring issue identification, escalation and resolution pathways, partnering with relevant medical/clinical functions, Country QA, GLFs and Dev QA.
• Actively manages Country issue identification and resolution in relation trial audits, inspections and delivers to CAPA implementation requirements.
• Is accountable for Country adherence/compliance to SOPs and, roll-out/adoption across Country Study & Site Operations for required training curricula per GDD targets.
• Drives continuous improvement in Study & Site Operations, fosters best practice sharing within the Country and supports Hub best practice sharing.
• Is responsible for hiring, development, retention and succession planning of talent including US Field Monitoring Head, Study Start Up Head and Portfolio Head(s).
• Is responsible for the allocation of Study & Site Operations resources within the Country SSO in collaboration with Hub Head (as appropriate).
• Manages, develops and recognizes Country performance of Country SSO associates in line with the Country objectives.
• Develops performance management processes to proactively manage key performance and quality indicators to ensure achievement of Country/Hub performance targets.
• Is responsible to implement and adopt global training strategy and tools within the Country and, ensures Country training needs are communicated to Global Training.
• Is responsible for Country budget and headcount allocation to achieve targets in co-operation with the Hub Head and Finance (as appropriate).
• Is responsible for driving the delivery of the Country Study & Site Operations productivity initiatives and targets.

Qualifications

• Required: Bachelor's Degree in life sciences.
• Required: Minimum 10 years’ experience in clinical research - planning, executing and/or monitoring clinical trials with minimum 4 years in a people management role.
• Required: Expert understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring.
• Required: Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards.
• Required: Superior leadership, strategic thinking and matrix management skills.
• Required: Established track record of leading successful teams.
• Required: Excellent site management capabilities with demonstrated negotiating and problem-solving skills including financial management.
• Required: Excellent organizational, interpersonal skills with extensive networking expected.
• Required: Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders.
• Preferred: Experience in matrixed team leadership.

Skills

• Leadership and matrix management
• Strategic planning and collaboration with cross-functional teams
• Negotiation, problem-solving and financial acumen
• Excellent oral and written communication; ability to present to senior leaders
• Regulatory and quality compliance expertise (GCP/ICH, FDA/EMA, SOPs)

Education

• Advanced Degree in scientific or business preferred.

Additional Requirements

• Travel: Up to 25% (domestic and international).