Key Responsibilities:
- Independently manage and provide strategic direction for oversight of assigned Preclinical Safety (PCS) and PK Science (PKS) study outsourcing for Therapeutic Areas.
- Translate project plans into internal/external work packages; schedule studies to meet milestones and submission deliverables.
- Ensure timely, accurate study-level planning and budget forecasting in project/study management tools.
- Coordinate operational strategies and serve as an interface among Scientific Project Teams, PCS/PKS Scientific Monitoring, Operations/External Partnerships, BR/Development Project Managers, and external CROs.
- Optimize and consolidate study requirements; influence selection of internal/external placements and CROs.
- Drive consensus with PCS/PKS stakeholders; ensure BR policies and compliance in external operations.
- Set up studies and lifetime forecasts; coordinate with Study Monitors for tracking and financial planning.
- Track and communicate schedule/cost changes; adjust grants/POs as needed; flag resource shortages.
- Lead CRO interactions: initiate study planning, obtain pricing, initiate funding, authorize study start; forecast and establish external study budgets.
- Support integrated scientific outsourcing strategy and 3R mindset for animal studies; ensure adherence to Novartis animal welfare standards.
- Lead operational excellence initiatives; coordinate meetings with CROs, Ops Experts, scientific staff, and stakeholders (e.g., Procurement, Quality, AWC).
Essential Requirements:
- Bachelorโs degree required; Masterโs or advanced degree desired in a PCS/PKS-related scientific/technical discipline.
- 5+ years in pharma or CRO experience with drug development projects (small/large molecules).
- Strong project management; ability to map deliverables/milestones/budget forecasts to study plans.
- Excellent communication/influencing skills; customer focus and negotiation skills.
- Ability to work independently in cross-functional teams; flexible mindset and strong organization.
- Strong analytical/problem-solving skills.
- Knowledge of outsourcing/CRO management tools (PowerBI, SharePoint, Smartsheet).
Desirable Requirements:
- PMP certification strongly preferred.
- Prior experience in scientific service functions or operational support.
Application Instructions:
- Not specified in the provided text.