Associate Director, Operations Expert (Multiple Positions) (Cambridge (USA))

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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).

About the Role

Key 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.
• 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.

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 negotiation skills are required.
• Ability to work independently within a cross-functional team environment with a flexible mindset and excellent organizational skills.
• Strong analytical and problem-solving skills.
• Extensive knowledge of tools and processes commonly used in outsourcing and CRO management- PowerBI, Sharepoint, Smartsheet
• Shows a commitment to continuous process and program improvement and is a good team player.

Desirable Requirements:

• PMP certification strongly preferred
• Prior experience in scientific service functions or operational support is a plus

The salary for this position is expected to range between $132,300 and $245,700 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

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.

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