Global Clinical Safety & Pharmacovigilance (GCSP) Business Operations & Operations Excellence Lead

Responsibilities:

The Business Operations & Operations Excellence Lead is an integral member of the GCSP Business Process & Technology team within GCSP PV Operations, responsible for providing function specific strategic oversight and business management support for GCSP global budget and resources to optimize coverage of current priorities, explore redistribution and at-risk planning for new opportunities.  This role will provide operations excellence leadership support to GCSP global project portfolio management, special projects, and key strategic initiatives.  In addition, The Business Operations & Operations Excellence Lead will be responsible for strengthening and cultivating cross-functional operational excellence with key GCSP functional partners in Clinical Development, Clinical Operations, Finance, Procurement, Legal, and Regulatory Affairs to build and maintain exceptional partnerships while maximizing value to GCSP and its customers. Drives integration activities as necessary across GCSP.

1.    Overall financial awareness and oversight in strict coordination with GCSP Finance business partner and processes, providing strategic value with insights into spending trends and to identify key opportunities for redistribution of budget and resources as opportunities present.
a.    Ensure a proactive, consistent and efficient budget and resource planning and management approach across all GCSP programs and departments to effectively anticipate business needs, including support for GCSP project portfolio, special projects, and key strategic initiatives. 
b.    Ensure accuracy of global GCSP budgets and resource plans with defendable justification and rationale, prior to GCSP leadership review and submission to Finance.
2.    Oversight and management of bus ops operational activities not covered by BON (Business Operations Network) , but still required within function – contracting, Pos, tracking spend against Pos (with contact or other resource supporting).  
3.    Identify opportunities for continuous improvement, innovation and customization to improve performance and productivity with limited budget and resource impacts.  Ensure that business process improvements and innovations maximize value and strengthen GCSP partnerships, processes and systems.  
4.    Implementation of operational excellence including overall GCSP project portfolio management, special projects and key strategic initiatives (e.g. Automation agenda).
5.    Effectively collaborate and engage with key GCSP stakeholders at all levels in the organization, including Clinical Development, Clinical Operations, Finance, Procurement, Legal, Regulatory Affairs, etc. to develop compliant procedures in line with industry standards and best practices.
6.    Management oversight of key integration activities among safety stakeholders (e.g., Clinical Development, Clinical Operations, Finance, Procurement, Legal, Regulatory Affairs, etc.)
7.    Develop and maintain strong working relationships with both internal and external collaborators and key LT-level stakeholders across all CSL geographical regions.
8.    Provides support to the Process Improvement & Innovation Lead, Business Operations Managers, Business Operations Specialists and other GCSP staff.  Management of the GCSP internship program with Drexel University.
 

Qualifications:

Education:

Degree (Bachelor/Masters/Diploma) in a Business related and /or scientific/medical/pharmaceutical discipline, preferably combined with relevant GCSP trial experience with a business focus.

Experience:

• 12+ years of a leadership role in Pv the biotech/ pharma industry
• Minimum 7 years managing departmental budgets, including experience with budget and resource plans, forecasts and reports
• Proven ability in financial acumen and working with industry tools (e.g. SAP)
• Knowledge of the overall process of drug development, with particular emphasis on Pharmacovigilance activities (additional Pharma R&D experience is preferred, e.g. clinical, regulatory, quality, commercial, legal, etc.)
• Experience preparing executive level reports
• Deep experience in project, program management, change management and process improvement

Competencies:

• Demonstrated leadership to drive results that are needed to achieve business objectives in accordance with company culture and values
• Ability to develop innovative, value-add solutions to problems and issues of a complex nature
• Strong analytical skills to manage and prioritize competing demands while remaining objective
• Strong verbal, written and presentation skills
• Excellent planning, organization and decision-making skills
• A commitment to producing high quality work product with an attention to detail
• Strong interpersonal skills with an ability to work independently and as a team member with all internal and external stakeholders
• Proficiency in MS Word, PowerPoint, Project, Excel

Our Benefits

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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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