Preclinical Business Operations Lead

Rockville, MD
March 16 2021
Other, Other
Organization Type
As Preclinical Business Operations Lead you will manage/lead/be responsible for…
  • Providing operational support for implementation of RDC US projects in Pre-clinical R&D group
  • Tracking and reporting of milestones, KPIs and deliverables to manage and optimize the performance of the Preclinical R&D department
  • Management of Preclinical R&D budget (Opex&Capex), laboratory supply spend, and point of use (POU) review within the RDC to help make decisions about prioritization and trade-offs.
  • Oversight and communication of risk management and deviation tracking, including issues specific to the US RDC
  • Management of process improvements, audit\inspection preparation and CAPAs for Preclinical R&D areas.
  • Contribute to Preclinical R&D scientific and operational strategy as needed
  • Support in relationship management with 3rd party providers and external collaborators on equipment and facilities processes to ensure laboratory support is provided
  • Preclinical R&D Information management (Management monitoring, Documentum, SAP, eLNB)
  • Supporting the management and delivery of Pre-clinical R&D Objectives

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Support Preclinical R&D Finance Partner in the maintenance of Opex/Capex information for Preclinical R&D Team. Lead and manage SMR based CAPEX purchases; acquisition of product, tracking, and review yearly including PIP project based submissions
  • Ensure laboratory based risks and issues are identified, managed and communicated effectively
  • Responsible for contributing to the Monthly Preclinical Update including the Preclinical deliverables and KPIs
  • Contribute to development and management of standards and processes across Preclinical R&D including the signature log for PRD US. Ensure that standards and processes are implemented globally (as required) throughout Preclinical R&D with a high level of compliance and quality.
  • Lead the Preclinical department in CAPA and Deviation Management. Assure deadlines are met and materials provided for CAPAs assigned to Preclinical US staff or global (as needed)
  • Serve as the Preclinical US R&D representative to lead & support process improvement and\or change management work streams, including cross-functional work streams, particularly when specific to US RDC. Participate as core member in Steering Committees as appropriate.
  • Support Preclinical function heads and leaders to liaise with relevant stakeholders, including but not limited to Discovery Performance Unit (DPU), Information technology (IT), Clinical Evidence Generation (CEG), Clinical R&D, Technical R&D (TRD), Portfolio Integration and Operation (PIO), Regulatory Affairs (RA), Finance, External R&D
  • Lead and manage the Management Monitoring Process for Preclinical US including KPIs management and annual review. Share best practices outside of Preclinical US to aid implementation in other parts of the organization
  • Participate as a Preclinical US representative to the meetings of QMS Equipment core team, Global quality objectives, WST and Quality Preclinical Forum, and other bodies as necessary

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS Degree from accredited university and at least 2 years of work experience in a laboratory setting and/or business environment
  • Project management and/or a scientific background.
  • Practical knowledge of the operations of a scientific laboratory.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • MS or equivalent education, preferably in a science or health related discipline and experience in laboratory operations.
  • Strong Project management skills.
  • Previous experience in the field of immunology or vaccinology desirable.
  • Excellent people and team management skills.
  • Proven track record of managing complex programmes.
  • Sensitive to the needs of diversified ethnic groups with the ability to build rapport across these groups.
  • Strategic thinking skills and achievement oriented.
  • Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.


If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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