Manager or Associate Director, Operations Expert

Band

Level 4

 

Job Description Summary

#LI-Hybrid

Internal Title: Manager, Operations Expert and Associate Director, Operations Manager

This role can be based in East Hanover, NJ or Cambridge, MA and will not have the ability to be located remotely.

As a Manager or Associate Director, Operations Expert you will manage, provide direction and ensure oversight of assigned Preclinical Safety (PCS) and PK Science (PKS) project plans for assigned Therapeutic Area(s).

In this role you will translate the project plan into study packages to be scheduled internally or externally to meet the key project milestones as well as ensure timely and accurate entry of study level planning and budget forecasting into the relevant project/study management tools.

You will also coordinate and drive the operational strategies within the assigned projects and acts as the interface between the Scientific Project Team, PCS Operations, PCS & PKS Scientific Monitoring functions, and BR & GDD Project Managers. Serve as Business Partner to Procurement and Finance.

 

Job Description

Key Responsibilities:

• Responsible for having oversight of assigned PCS & PKS projects, work with the PCS & PKS Project Team Member (PTM) and PCS & PKS line functions in creating realistic project plans. Coordinates the project plan execution to ensure accurate study initiation and scheduling right the first time, in alignment with project milestones endorsement.  Drive project timelines in consideration of project prioritization as provided by Research and Development Program Office. 
• Active member on assigned Project/Strategy Teams.  The Operations Expert is responsible for consolidating study requirements from the team and driving internal and external study placement, selecting the Contract Research Organization (CRO), and coordinating study parts outsourced at multiple CROs to meet project/study deadlines.
• Drive consensus with the PCS & PKS stakeholders, and enable the preparation, placement and scheduling of study requests and study details in the relevant planning systems (i.e WORKBENCH, HORIZON, etc.)
• Fully imbed speed and simplification concepts into business workflows; create work packages in Workbench and Horizon in a timely manner, keep Workbench work package schedules and studies up to date via accurate study level planning, and fully engage cycle timeline management to support operational excellence.
• Provide directions to effectively manage the planning of studies from integrated project assets
• Ensure completeness of financial plans in Workbench via accurate study level Lifetime Forecast planning
• Keep Project Manager / Project Team Members informed on Workbench changes (schedule and cost) and flag resource shortages that may impact project execution and/or related project
• Proactively work with Global Program Project Manager in GDD to develop and propose work packages for approval when projects are proposed for approval at governance boards
• Lead interactions with Novartis qualified CROs to initiate study planning, obtain pricing/quotation, initiate the funding process and authorize the Study starts. Responsible to forecast and establish a budget for externally planned studies for each assigned project plan and maintain overall budget accuracy.
• Coordinates the timely arrival of compound vehicle, excipients, etc. at the test facility in collaboration with Drug Supply colleagues to enable timely study initiation.
• Support an integrated scientific outsourcing strategy within the respective Therapeutic Areas of PCS and PKS.  Ensure that new scientific and technical needs related to a Therapeutic Area are supported either internally or by the global PCS & PKS outsourcing strategy.
• Assure that PCS/PKS projects adhere to Novartis policies and compliance requirements. Demonstrate 3R mindset when planning animal studies in accordance with Novartis animal welfare standards.

Essential Requirements:

• Bachelor degree required; advanced degree (Master/PhD) in a scientific/technical or Toxicology/PCS-related discipline preferable

• 3-5 years experience (Master/PhD); 7-10 years experience (Bachelor) in the pharmaceutical industry or CRO working with small/large molecules and various platforms such as gene therapy, radio ligand therapy, and CAR-T.

• Proficient project management skills; understanding of mapping key deliverables, milestones, budget forecasting with study plans

• Excellent communication skills both oral and written – must be able to interact with Internal and External Stake Holders  

• Strong stakeholder focus; experience working in service functions or providing support. Strong negotiation sk