Associate Director, Operations Expert

Novartis • Cambridge, MA

2d • Hybrid

About The Position

In the role of Associate Director, Operations Expert you will independently manage, provide strategic direction and ensure oversight of assigned Preclinical Safety (PCS) and PK Science (PKS) study outsourcing for assigned Therapeutic Area(s). In this key role you will translate the project plan into work packages to be scheduled internally or externally to meet key project milestones and submission deliverables. In addition, you will ensure timely and accurate entry of study level planning and budget forecasting into the relevant project/study management tools. As the Associate Director, Operations Expert you will coordinate and drive the 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. In addition, you will act as the business interface driving the overall pre-clinical outsourcing execution for PCS and PKS, including utilizing LabCorp/CRL as a primary PCS global partner; contribute and/or lead 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 TM.

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. PMP certification strongly preferred.
• 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 negotiation skills are required.
• Ability to work independently within a cross-functional team environment with a flexible mindset and excellent organizational skills.
• Extensive knowledge of tools and processes commonly used in outsourcing and CRO management.
• Must be able to productively collaborate in a global matrix organization and simultaneously lead cross-functional projects in various disciplines as required.

Nice To Haves

• Prior experience in scientific service functions or operational support is a plus.

Responsibilities

• 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.
• 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
• 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.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees