*8 plus years' experience in pharmaceutical industry /biotech /CRO drug development environment. *Excellent understanding of drug development process, early clinical development preferred. *Superior knowledge of clinical trials site selection, global /country specific requirements, timelines and challenges in clinical trial execution process *Expert project management, analytical and problem solving skills. *Demonstrated ability to work effectively in a global, matrix organization and build strong positive relationships. *Advanced computer literacy. *Excellent organizational skills. Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude. *Ability to work independently with demonstrated willingness to make decisions and to take responsibility for such. *Excellent influencing and negotiating skills.
WHY CONSIDER NOVARTIS?
817 million. That's how many lives our products touched in 2018. And while we're proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
7000 patients, 1200 clinical sites, 40 countries, 100+ clinical studies led by Novartis Clinical Sciences & Innovation (CS&I) last year.
Who are we? CS&I is a dynamic group of Clinical Scientists who plan and execute Novartis' early phase global clinical trials. From First-in-Human, to Proof-of-Concept, and beyond, we design and operationalize clinical trials, ensuring they run smoothly, on time and, most importantly, with patients' interests in the forefront. Last year we recruited over 7000 patients in around 100 clinical trials run across 40 countries. We play a pivotal role in transitioning discovery research to clinical practice.
As a Strategic Feasibility Expert within CS&I you will be accountable for the clinical feasibility strategy for NIBR therapeutic areas (TAs) and patient trials managed by Translational Medicine (TM).
The Strategic Feasibility Expert is a TA-aligned, single point-of-contact to ensure study timelines and enrolment plans reflect site landscaping and contracting requirements enabling successful trial execution. The Strategic Feasibility Expert will lead early medical and operational feasibility, proactively identify high quality academic and commercial sites, and engage early with key strategic investigators, sites and networks. The Strategic Feasibility Expert will work closely with the clinical trial team (CTT), the TA line function teams, the contracting group, the Global Development Operations Trial Monitoring Organization (GDO-TMO), and Country Pharma Organizations (CPOs), aligning with them and keeping all stakeholders informed of progress and issues.
Your main responsibilities will be to:
*Provide early, strategic feasibility input (including early medical and operational feasibility) for a given therapeutic area (TA), indication, or study, through the utilization of relevant tools, databases, and historical metrics. *Be accountable within the CTT for appropriate site identification and anticipating and relaying hurdles/delays for consideration in ultimate selection and timelines. Consolidates feasibility feedback and potential site list for CTT decision making. You may act as the point of escalation when a site selection or sourcing challenge is identified which can impact the trial timelines. *Engage internally and externally to identify new investigators /sites. Maintains knowledge of investigators /sites mapping in alignment with TA /indication strategy. Maintains awareness of site performance data e.g. recruitment, time to contract, master agreements (MSAs). *Identify and maintain relationships with key strategic key strategic investigators, sites, and networks for a given indication, program, or TA. Identifies and establishes strategic partnerships as appropriate. *Conduct /advise patient recruitment strategy, enrolment projections and scenario modeling in order to improve the reliability of forecasting at trial, country and/or site level. Maintains awareness of country related impacts on recruitment and budget to help guide clinical trial global footprint and optimize most effective recruitment. *May work in close collaboration with the Global Development Operations-Trial Monitoring Organization (GDO-TMO), ensuring a timely handover of the strategic feasibility information package for the site-specific operational feasibility. Organizes regular TA portfolio reviews for early planning and communication.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.