Study & Site Operations- US Country Head (Remote)

Job Description Summary

Job Description

Key Responsibilities:

Trial Monitoring strategy

• Defines and drives Country Study & Site Operations strategy to achieve Hub/Country business and trial strategy 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

Allocation, initiation and conduct of trials

• In collaboration with the US SSO Country Head Portfolio, defines and implements Country (Hub, where applicable) 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

Delivery of quality data and compliance to quality standards

• Actively monitors the KQI's 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, GLF's 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

Management of people and resources management

• 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

Budget and productivity

• 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

Essential Requirements:

• 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
• Expert understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
• 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
• Superior leadership, strategic thinking and matrix management skills
• Established track record of leading successful teams
• Excellent site management capabilities with demonstrated negotiating and problem-solving skills including financial management
• Excellent organizational, interpersonal skills with extensive networking expected
• Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders

Desirable Requirements:

• Advanced Degree in scientific or business preferred
• Experience in matrixed team leadership preferred

The salary for this position is expected to range between $225,400 and $418,600 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired