Associate Director, Operations Expert (Multiple Positions)

Responsible for oversight of assigned PCS & PKS study externalization processes and for working with the PCS & PKS Project Team Member (PTM) and PCS & PKS Line Functions to create realistic project plans. Coordinate the project plan execution to ensure accurate study initiation and scheduling in alignment with project milestones. Drive project timelines, considering the project prioritization as set by the Therapeutic Area (TA).

As an active member of assigned Project/Strategy Teams, responsible for optimizing and consolidating study requirements, influencing and selecting internal and external study placements and the Contract Research organization(s) (CROs) to meet project/study deadline.

Influence and drive consensus with PCS & PKS stakeholders, and enable the preparation, placement and scheduling of study requests and study details in the relevant planning systems. Ensure that BR policies and compliance are achieved in external operations.

Ensure that studies and lifetime forecasts are set up properly, and coordinate with Study Monitors once the studies have started to provide accurate study level tracking and financial planning.

Keep Project Manager and PTM informed on schedule and cost changes, adjust grants and POs as necessary, and flag resource shortages that may impact project execution and/or timelines.

Lead interactions with Novartis qualified CROs to initiate study planning, obtain pricing/quotations, initiate the funding process and authorize the Study start. Responsible for forecasting and establishing a budget for externally planned studies for each assigned project plan and maintain overall budget and forecast accuracy in internal tracking systems.

Support an integrated scientific outsourcing strategy in support of the assigned project within the framework of PCS & PKS. Participate in and/or directly contribute to new scientific and technical needs related to a TA that are supported either internally or by the global PCS & PKS outsourcing strategies

Demonstrate a 3R mindset when planning animal studies and ensure adherence to Novartis animal welfare standards.

Suggest and/or lead Operations/External Partnerships operational excellence initiative(s) to deliver more efficient and higher impact services for PCS & PKS (e.g. managing external animal colonies, increasing TM access to animal tissues). Coordinate regular team meetings to review timelines, status and troubleshoot issues in partnership with CRO management, Ops Experts, scientific staff from both organizations, and other stakeholders as applicable (e.g. Procurement, Quality, AWC).

Serve as a PCS representative in the EPRM risk assessment process. Provide support for maintaining supplier data and facilitate Novartis Commodity Code (NCC) selection throughout supplier onboarding and renewal activities within S360 and MDGS.

Serves as Operations Expert for PCS Collaborations and initiates contracts and purchase orders via Scientist.com.

Assist Alliances managers in developing relationships with key and niche providers.