Translational Clinical Oncology Supplier Lead (Location: NJ OR MA)

Translational Clinical Oncology Supplier Lead (Location: NJ OR MA)
817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, 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?

The TCO Supplier Lead is an adhoc member of the Clinical Trial Team (CTT) accountable to identify, select, and manage performance of external service suppliers, focusing on those unique to the TCO type of Clinical Studies (such as Biomarker Labs, cardiac safety, IRT, imaging), but in collaboration with the Clinical Trial Leader, Procurement, and the Quality Assurance teams (QA) to assure the delivery of quality, timely and cost-effective external deliverables and services to support the TCO pipeline.

The TCO Supplier Lead provides a single point of contact (SPOC) for all unique TCO supplier services at a trial level and is the first point for issue escalation, acting as a conduit for clear communication and robust daily oversight.

Accountable as SPOC for managing daily supplier oversight and management at the CTT level:
•Accountable to the CTT and other line functions within TCO in related processes and activities of identification, qualification, selection and contracting Suppliers.
•Collaborate with the External Development Operations (EDO) Relationship Leads to support supplier governance and oversight for qualified suppliers through documented performance and issue management
•Accountable to the CTT in the process of outsourcing and selection of suppliers (e.g. completing the Study Specification Worksheets (SSW), providing templates for request for proposal, supplier selection documents). If required, support contract negotiations.
•Drive timeline and deliverable management of all external activities from identification of supplier needs through closeout and final invoices.
•Support budget management by tracking work performed against contract to support CTT with review, approval and processing of invoices.
•Depending on outsourced service, perform testing and validation (User Acceptance Testing) to ensure final system programming meet service requirements.
•Evaluate, document, track and manage performance and oversight of Suppliers with input from CTTs, using appropriate tools.
•Accountable to the CTT to ensure changes to protocol, allocation or other study designs are consistently shared and incorporated into supplier budgets, timelines, and specifications.
•Intervene and accountable to the CTTs in Supplier issue management. Escalate issues that could present a risk to the patient safety, validity/integrity of data, regulatory acceptance and/or to Novartis business reputation in timely manner in accordance to relevant procedures.
•Responsible for ensuring supplier compliance with NVS SOPs and business guidance. Responsible, in partnership with QA, to document trial level deviations and perform Root Cause Analysis (RCA) and CAPAs as appropriate.
•Support the development and implementation of process changes and standards to continuously improve and optimize interaction by assessing trends, quality issues, and contract issues driving suppliers’ quality improvement.
•Participate in CTT meetings when required to provide overview and update on supplier deliverables.
•As required create appropriate training for CTT members and Suppliers for CTT Kick Off and investigator meetings.
•At study close out, accountable to ensure proper and complete supplier related activities are managed to allow timely study closure and appropriate reconciliation.

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.

Desirable requirements:
•Education: Bachelor’s degree required; Relevant advanced degree (MBA, Pharm.D, MD or PhD preferred)
•8-10 years successful career track record in pharmaceutical clinical drug development and/or clinical supplier technology (BioPharma or with a CRO/Central Lab/Specialty Provider) including expertise in clinical operations and, management of outsourced trial activities
•Thorough understanding of supplier provided technology, media, tools, trends and adoption rates
•Good understanding of clinical research and development processes including, quality & regulatory standards and policies relevant to defined services.
•Good understanding of contracts and payment terms (including basic legal understanding of terms and conditions)
•Expert in understanding trial related supplier marketplace (e.g. CRO/Central Labs/Specialty Provider)
•Profound knowledge in finance (understanding of cost drivers for clinical trials) as it relates to contracts and cost reductions.
•Good knowledge of GCP, GMP and FDA part 11
•Excellent understanding of clinical trial methodology, GCP and medical terminology.

Why consider Novartis?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.
Oncology NIBR
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time