Job Description
The Clinical Study Costing Director is a position that sits within the Global Clinical Trial Strategy & Design Office. The position will have primary responsibility for costing clinical studies and evolving our processes for developing competitive cost structures. This position will work closely with the functional leaders across Clinical Development Services; including, Operational Strategy & Planning, Project Management, Clinical Operations, Data Management, Drug Safety, Global Site Services, and Global Regulatory Services.
Activities Will Include The Following
Serve as Clinical Study Costing Director for assigned business development opportunities to ensure clear alignment of the project costing to the customized delivery strategy
Ensure accurate project costing across the CDS Phase II-IV portfolio for staff fees, vendor costs and pass-through items
Drive cost competitiveness and efficiency across all functions to further enhance the Covance win rate
Responsibilities
Collaborate with all CDS functional leaders and providing final operational approval/sign-off for all initial study operating budgets. This role can be based in any of our offices or home based in Europe. Other responsibilities will be:
Responsibilities/Duties
Lead costing compilations on ballpark estimates, RFP responses, and Non-Compete Awarded Projects – 70%
Lead global coordination of costings in line with project delivery strategy by attending multiple strategy meetings and providing the operational guidance for the costing team – 10%
Define and collaborate with Senior Directors and Resource team to develop plans for key resources. – 10%
Promote effective teamwork within Covance departments and offices. Resolve conflicts as needed. – 5%
Ensure appropriate communication with Client Services, CTS&D, PMO, and Operational Groups. – 5%
Perform appropriate handover training, detailing rationale of costing to project Bid Defense team and the Operational Project Team.
Establish excellent working relationships with all functional areas and deliver operational excellence.
Cover Global Triage Meetings.
Provide proposal text, assumptions review and writing to support costing approach for specific opportunities.
Solicit support from functional reviewers to solidify costing strategy.
Manage all aspects of designated costings; working with the proposals lead to give final approval.
Provide performance feedback of team members to respective functional area leadership.
Preferred Qualifications
Education/Qualifications We are typically looking for someone with a Bachelor's degree, life science preferred but not essential. Masters or other advanced degree would be beneficial but not a must.
Experience The ideal person would have typically 8 or more years of drug development and clinical research Experience (pharmaceutical, biotech or CRO), preferably including previous Experience in managing global clinical projects. Experience in managing global programs with large financial value and complicated structure, multiple vendors and/or sub-CROs and Academic Research Organizations in a virtual environment.
Demonstrated ability to handle multiple competing priorities.
Ability to utilize resources effectively on large global scale including programs with multiple budgets
Financial awareness and ability to actively manage financial tracking systems.
Demonstrated ability to lead by example and to encourage team members to seek solutions.
Excellent communication and presentation skills and confidence presenting to senior management.
Ability to negotiate and liaise with clients in a professional manner.
Detailed knowledge of financial control procedures (e.g. costing systems, TAQ / EVA).
Thorough knowledge of project management processes, time and cost estimate development and ICH and GCP.
Broad knowledge of drug development process and client needs.
This role will be focusing on Oncology but we will consider Experience in all therapeutic areas.
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