Head of Clinical Vendor Contracting - United States
- The Head of Clinical Vendor Contracting is responsible for ensuring that all clinical vendor contracts in support of all clinical trials ope rationalized by Global Clinical Operation’s’ (GCO) operationalized clinical trials are in place with all vendors on time so as not to impact program/study milestone delivery, ensuring both GCP/GXP as well as financial compliance throughout.
- In partnership with the Business, Finance, Compliance and Procurement Strategic Sourcing, this person will participate with in the development of the outsourcing strategy as well as all policies and procedures around vendor selection and contracting ensuring adherence as it relates to clinical vendor .
- This person will provide leadership and oversight to the ‘Vendor Contract Management’ team to ensure a consistent approach in operational delivery across each vendor category as well as oversight of the whole portfolio to ensure we are providing a best in class approach with regards to vendor contracting for GCO while delivering compliant contracts within all SLAs and timelines.
- They will also be responsible for representing CSP in governance forums, as needed.
- Provide leadership and oversight to ensure we have an efficient and effective Vendor Contract Management Model in place in support of all clinical trials operationalized by GCO (e.g. Strategic Research Collaborations and all studies and in Phases I-IV)
- Partner with Procurement Strategic Sourcing and other key stakeholders to develop a lean and robust overarching vendor outsourcing strategy
- Ensure a consistent approach in the development of a vendor category level outsourcing strategy
- Ensure adherence and a consistent approach within each category level vendor strategy
- Provide leadership and oversight in the development and implementation of any processes and tools needed to ensure direct and accurate transfer of information needed that enables a lean and efficient vendor contract model through establishing establishment of clear communication pathways between the R&D stakeholders, the Program Demand Management team and the Contracts team.
- Work Collaborate with the Head of Program Demand Management and other stakeholders to define/refine an exception process for overall evaluation and management of a new service / vendor selection
- Lead / contribute in the creation and revision of any controlled documents (such as Job Aids) or vendor demand process development in support of a proactive, lean and efficient vendor contracting model
- Provide ongoing portfolio level leadership and oversight to ensure a consistent and compliant approach to clinical vendor contracting along with a focus on continuous improvement
- Lead cross functional discussion forums to enhance best practice standards through incorporation of lessons learned, industry trends and audit experiences with a focus on clinical and financial compliance
- Identify trends across vendor categories to ensure we have and efficient, compliant and robust contract outsourcing model (continuous improvement) utilizing KPI’s/metrics to measure efficiency, productivity and process improvements
- Working with both the planning team along with R&D stakeholders, contribute to the development of automated approach from a planning perspective that will enable our vendors to meet our needs
- Enable the team to develop and enhance vendor category expertise providing oversight and leadership working with our vendors and Strategic Sourcing to ensure a lean model in support of the delivery of services needed for GCO operationalized trials and beyond
- Develop process to review study-level pricing and business terms based on master rate card/pricing models to ensure consistent application of contractual terms
- Uphold negotiated CRO pricing by correctly interpreting contractual terms and ensure all study budgeting/contracting are compliant with the Master agreements
- Collaborate with the Category Managers on CRO pricing methodology/negotiations as needed to ensure all necessary negotiation inputs are delivered to the pricing team
- Oversight and Management of the Clinical Vendor Contracting Team
- Effectively oversee and manage the team resources to meet portfolio needs
- Hire train and coach the team, leveraging the skills and interests of each team member whilst promoting a culture of partnership, efficiency, high performance and continuous improvement / development
- Ensure all team members have clearly defined performance objectives and development plans and that feedback is being provided on a regular basis including 1:1 meetings, formal mid/end of year reviews
- Promote a cohesive and positive working environment between the broader team, Procurement, Finance / Compliance as well as the broader Business stakeholders
- Lead/participate in department and/or GCO/R&D initiatives that have direct impact to role
- Minimum of 8+ years’ experience in a clinical vendor management/clinical outsourcing position in the pharmaceutical/biotechnology industry
- Extensive experience in vendor contract negotiation and execution across SRC and Phase I-IV trials
- Experience in clinical vendor strategy, contracting and financial processes; proficient with procure to pay systems (e.g. Oracle, MarkView, etc.)
- Broad knowledge of the clinical development process (Pharma R&D and Clinical) with a clear understanding of operational and quality (GCP/GXP/Financial) aspects
- Strong Project Management and contract negotiation skills using a ‘hands-on’ approach
- Excellent people and customer service skills demonstrating an ability to work as a team player within matrix teams, interacting with all levels of staff, both within and external to the company to establish good partnerships/alliances
- Demonstrated ability to manage teams and drive results. Ability to influence stakeholders without authority
Bachelor’s Degree required
MBA or other related business experience is a plus
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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