Study & Site Operations- US Country Head (Remote)

Novartis

6d•Remote

About The Position

The SSO Country Head is accountable for all country clinical operations activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials. The SSO Country Head is responsible for implementing the Study & Site Operations archetype and Hub/Country strategy, while delivering to Country budget and productivity targets in line with Study & Site Operations and local business objectives. Operationally responsible for building a high performing team culture and ensuring standardization across Development Units - including talent development, performance management and established monitoring procedures in accordance to GCP, ICH and local regulations. The SSO Country Head is responsible for Study & Site Operations structure integration within Country CSO and Medical to ensure alignment on portfolio strategy, prioritization and performance to aligned objectives for GDD trial delivery. The SSO Country Head can also undertake additional responsibilities as GDD Country Coordinator (if applicable refer to separate GDD Country Coordinator Role Profile). #LI-Remote Internal Title: SSO Country Head Location: Remote This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel

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

Nice To Haves

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

Responsibilities

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
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
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
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