摘要
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.
About the Role
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 skills are a must.
- Ability to work collaboratively, adaptable, flexible and possesses excellent organizational and interpersonal skills. Strong analytical and problem-solving skills.
- Must be able to work independently in a matrix organization.
To be considered at the Associate Director level:
- Must have strong experience working within a global team environment, cross functional/divisional teams and be a strong team player.
- Strong knowledge of tools and processes in outsourcing, and CRO management required
- Must have experience in leading projects within a matrix and global organization.'
This is a dual level posting. The final level and title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.
- Manager, Operations Expert salary range from $114,100 to $211,900
- Associate Director, Operations Expert salary range from $132,300 to $245,700
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
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