Key Responsibilities:
- Oversee assigned PCS & PKS study externalization processes; create realistic project plans with PCS & PKS PTMs/line functions, coordinate execution for accurate initiation/scheduling aligned to milestones, and drive timelines based on TA prioritization.
- Optimize/consolidate study requirements and partner with CRO(s) to meet project/study deadlines.
- Prepare, place, and schedule study requests/details in planning systems; ensure BR policies and compliance in external operations.
- Ensure studies and lifetime forecasts are set up properly; coordinate with Study Monitors for accurate tracking and financial planning once studies start.
- Track and communicate schedule/cost changes; adjust grants/POs as needed; flag resource shortages impacting execution/timelines.
- Work with qualified Novartis CROs to initiate planning, obtain pricing/quotations, start funding, and authorize study start; forecast and establish budgets for externally planned studies and maintain budget/forecast accuracy.
- Apply a 3R mindset for animal studies and ensure adherence to Novartis animal welfare standards.
- Contribute to operational excellence initiatives; participate in meetings to review status and troubleshoot with CRO/ops/scientific stakeholders.
- Support EPRM risk assessment; maintain supplier data and facilitate Novartis Commodity Code (NCC) selection during onboarding/renewal (S360/MDGS).
- Support PCS collaborations; initiate contracts/POs via Scientist.com.
- Assist Alliances managers in building relationships with providers.
Essential Requirements:
- BS/MS or advanced degree in a scientific/technical field related to PCS/PKS.
- 5+ years pharmaceutical industry or CRO experience working with small/large molecules in drug development.
- Strong project management; able to map deliverables/milestones/budget forecasts to study plans (PMP or CA-AM a plus).
- Excellent communication/influencing; strong customer focus and negotiation skills.
- Independent, cross-functional, flexible, and highly organized.
- Strong analytical/problem-solving skills.
- Knowledge of outsourcing/CRO management tools (PowerBI, SharePoint, Smartsheet).
- Ability to collaborate in a global matrix and lead cross-functional projects.
- Commitment to continuous improvement and teamwork.
Compensation & Benefits:
- Salary expected range: $103,600β$192,400/year; performance cash incentive; potential annual equity eligibility. US-based eligible employees receive health/life/disability benefits, 401(k) with match, and time off.