Associate Director, Operations Expert
Novartis Group Companies, Cambridge, MA, United States
Job Description Summary
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Location: Cambridge, MA USA
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. You will also 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 act as the interface between the Scientific Project Team, PCS & PKS Scientific Monitoring functions, Operations/External Partnerships, and BR or Development Project Managers.
Additionally, 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; lead Operations/External Partnerships initiatives that support external outsourcing strategies, operational excellence, and expanding the scope of Operations/External Partnerships in support of TM.
Key Responsibilities:
Oversee assigned PCS & PKS study externalization processes, work with the PCS & PKS Project Team Member (PTM) and PCS & PKS Line Functions to create realistic project plans, coordinate project plan execution to ensure accurate study initiation and scheduling in alignment with project milestones, and drive project timelines. Act as an active member of assigned Project/Strategy Teams, optimizing and consolidating study requirements, influencing and selecting internal and external study placements and the Contract Research organization(s) (CROs) to meet project/study deadlines. 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 funding process, authorize the study start, forecast and establish budgets for externally planned studies, and maintain overall budget and forecast accuracy. 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 Therapeutic Area. Suggest and/or lead Operations/External Partnerships operational excellence initiatives to deliver more efficient and higher impact services for PCS & PKS, coordinate regular team meetings to review timelines, status and troubleshoot issues in partnership with CRO management, Ops Experts, scientific staff, Procurement, Quality, AWC, etc. Serve as a PCS representative in the EPRM risk assessment process, maintain supplier data, and facilitate Novartis Commodity Code (NCC) selection throughout supplier onboarding and renewal activities within S360 and MDGS. Initiate contracts and purchase orders as Operations Expert for PCS Collaborations 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. Excellent project management skills; able to map key deliverables, milestones, and budget forecasts to study plans (PMP certification strongly preferred). Outstanding communication and influencing skills to interact productively with internal and external associates from different countries, disciplines and levels. Strong customer focus and good negotiation skills; prior experience in scientific service functions or operational support a plus. 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. Collaborate productively in a global matrix organization and simultaneously lead cross‑functional projects in various disciplines as required. Salary and Benefits
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 such as relevant skills and experience, and will be reviewed periodically. 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 additional benefits. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays, and other leaves. 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 and Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please send an e‑mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired
Analysis Decision Making Skills Operational Excellence Operations Problem Solving Skills Reporting Results‑Oriented Team Management Waterfall Model
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Oversee assigned PCS & PKS study externalization processes, work with the PCS & PKS Project Team Member (PTM) and PCS & PKS Line Functions to create realistic project plans, coordinate project plan execution to ensure accurate study initiation and scheduling in alignment with project milestones, and drive project timelines. Act as an active member of assigned Project/Strategy Teams, optimizing and consolidating study requirements, influencing and selecting internal and external study placements and the Contract Research organization(s) (CROs) to meet project/study deadlines. 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 funding process, authorize the study start, forecast and establish budgets for externally planned studies, and maintain overall budget and forecast accuracy. 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 Therapeutic Area. Suggest and/or lead Operations/External Partnerships operational excellence initiatives to deliver more efficient and higher impact services for PCS & PKS, coordinate regular team meetings to review timelines, status and troubleshoot issues in partnership with CRO management, Ops Experts, scientific staff, Procurement, Quality, AWC, etc. Serve as a PCS representative in the EPRM risk assessment process, maintain supplier data, and facilitate Novartis Commodity Code (NCC) selection throughout supplier onboarding and renewal activities within S360 and MDGS. Initiate contracts and purchase orders as Operations Expert for PCS Collaborations 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. Excellent project management skills; able to map key deliverables, milestones, and budget forecasts to study plans (PMP certification strongly preferred). Outstanding communication and influencing skills to interact productively with internal and external associates from different countries, disciplines and levels. Strong customer focus and good negotiation skills; prior experience in scientific service functions or operational support a plus. 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. Collaborate productively in a global matrix organization and simultaneously lead cross‑functional projects in various disciplines as required. Salary and Benefits
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 such as relevant skills and experience, and will be reviewed periodically. 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 additional benefits. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays, and other leaves. 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 and Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please send an e‑mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired
Analysis Decision Making Skills Operational Excellence Operations Problem Solving Skills Reporting Results‑Oriented Team Management Waterfall Model
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