Job Description Summary

#LI-Hybrid
Location: Cambridge, MA USA

Helps manage 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 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.

Job Description

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 and working with the Contract Research organization(s) (CROs) to meet project/study deadline.

• 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.

• Work 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.

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

• Contribute to 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). Participate in 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).

• Assist 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.

• Support PCS Collaborations and initiate contracts and purchase orders via Scientist.com.

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

Essential Requirements:

• BS/MS or other advanced degree in a scientific/technical area of a PCS or PKS-related discipline

• 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 or CA-AM a plus.

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

• 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

• Must be able to productively collaborate in a global matrix organization and simultaneously lead cross-functional projects in various disciplines as required.

• Shows a commitment to continuous process and program improvement and is a good team player

The salary for this position is expected to range between $103,600 and $192,400 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.

To learn more about the culture, rewards and benefits we offer our people click here

 

Salary Range

$103,600.00 - $192,400.00

 

Skills Desired

Analysis (Inactive), Databasing, Decision Making, Operations (Inactive), Problem Solving Skills (Inactive), Reporting (Inactive), Team Management, Waterfall Model