Associate Director, Operations Expert (Multiple Positions)
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Responsibilities
- 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.
- Demonstrate a 3R mindset when planning animal studies and ensure adherence to Novartis animal welfare standards.
- 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.
- Essential Requirements:
- Bachelor's degree required. Master's or other advanced degree in a scientific/technical area of a PCS or PKS-related discipline desired.
- At least 5 years of experience in the pharmaceutical industry or at a CRO working with small/large molecules in drug development projects
- Possesses excellent project management skills and able to map key deliverables, milestones, and budget forecasts to study plans.
- Outstanding communication and influencing skills - must be able to productively interact with internal and external associates from different countries, disciplines and levels.
- A strong customer focus along with good neg
Additional Information
Job Description Summary #LI-Hybrid Location: Cambridge, MA USA The Associate Director, Operations Expert Independently manages, provides strategic direction and ensures oversight of assigned Preclinical Safety (PCS) and PK Science (PKS) study outsourcing for assigned Therapeutic Area(s). Translates the project plan into work packages to be scheduled internally or externally to meet the key project milestones and submission deliverables. Ensures timely and accurate entry of study level planning and budget forecasting into the relevant project/study management tools. Coordinates and drives operational strategies within the assigned projects and acts as the interface between the Scientific Project Team, PCS & PKS Scientific Monitoring functions, Operations/External Partnerships, and BR or Development Project Managers as well external CRO partners. Contributes and/or leads Operations/External Partnerships and TM initiatives to improve external study transparency, simplification, and communication. This may include leading Operations/External Partnerships initiatives which support external outsourcing strategies, operational excellence, or expanding the scope of Operations/External Partnerships in support of Translational Medicine (TM). Job Description
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