Job Description

THE COMPANY

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, MS and neuroimmunology, movement disorders, neuromuscular disorders, acute neurology, neurocognitive disorders, pain, and ophthalmology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

Global Business Services and Business Optimization The Global Business Services (GBS) and Business Optimization team is a newly formed organization established to transform Biogen’s business processes to set a platform to scale global operations, fuel commercial growth and the innovation pipeline.  Further, GBS will provide further value by developing and delivering a suite of business solutions and support services that are valued by internal customers.   GBS will deliver services by leveraging a global delivery model, operational transparency and metrics, leveraging global best practices, and a service-oriented process improvement culture.   All solutions will be supported by strong business cases and ultimately monitored for the effectiveness and efficiency against benchmarks and service level agreements.

The vision of GBS at Biogen is to be recognized as a world-class Global Business Services organization driven by the desire for excellence in its people, business solutions, execution and partnerships with internal customers.   

THE POSITION

The Head of Clinical Contracts Delivery is responsible for ensuring that vendor contracts in support of all global clinical trials operationalized by Global Clinical Operations (GCO) are in place with all vendors on time so as not to impact program/study milestone delivery, ensuring both Good Clinical/Lab Practices as well as financial compliance throughout. In partnership with the Research & Development, Finance, Compliance and Strategic Sourcing, this role will participate in the execution of the outsourcing strategy as well as all policies and procedures around vendor selection and contracting ensuring adherence to contractual terms as it relates to clinical vendors.  The role will lead the ‘Vendor Contract Management’ team to provide a best in class to vendor contracting that meets or exceeds all SLAs and KPIs in the delivery of compliant contracts. They will also be responsible for representing Clinical Services Procurement (CSP) in governance forums, as needed.

1. 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 •    Partner with Strategic Sourcing, Program Demand Management (PDM) and key Business stakeholders to support a lean and robust overarching vendor outsourcing strategy for all key clinical services •    Collaborate with PDM team to ensure a consistent approach in the development of a category level outsourcing strategy across the portfolio of trials and within each category level vendor strategy •    Provide leadership and oversight in the development and implementation of processes and tools needed to ensure direct and accurate transfer of information that enables a lean and efficient vendor contracting model through establishment of clear communication pathways between R&D stakeholders,  the PDM team and the Contracts Delivery team. •    Manage the Functional Service Provider relationship and annual budget for contract execution services •    Collaborate with all stakeholders to define/refine all processes including evaluation and onboarding of a new services/vendors, creation and execution of purchase requisitions, creation of audit-compliant documentation for TMF uploads, etc. •    Lead/contribute to the creation and revision of process flows, job aids in support of a proactive, lean and efficient vendor contracting model •    Negotiate and reduce lead times with all key vendors to enable more operational flexibility in meeting SLAs and timelines.
2. 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 •    Jointly-lead the CSP Continuous Improvement program - 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 an efficient, compliant and robust contract outsourcing model (continuous improvement) utilizing KPI’s/metrics to measure efficiency, productivity and process improvements •    Working with the both the PDM team and R&D stakeholders, contribute process improvement from a planning perspective that will enable our vendors to meet our needs •    Enable the team to enhance vendor category expertise providing oversight and leadership working with our vendors and Strategic Sourcing by driving the category aligned model to the next level in support of the delivery of contracts •    Continuously improve processes 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 vendor pricing by correctly interpreting contractual terms and ensure all study budgeting/contracting are compliant with the Master agreements •    Collaborate with the Category Managers on vendor pricing methodology/negotiations as needed to ensure all necessary negotiation inputs are delivered to the pricing team
3. Oversight and Management of the Clinical Vendor Contracting Team •    Effectively oversee and manage team resources to meet portfolio needs across all programs and studies and set priorities appropriately •    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, career development plans •    Promote a cohesive and positive working environment between the CSP team, Strategic Sourcing, Finance / Compliance as well as broader Business stakeholders
4. Lead/participate in department and/or GCO/R&D initiatives that have direct impact to role a) Contribute to department-wide Continuous Improvement initiatives b) Collaborative on business-initiated innovations that enable better trial execution

Qualifications

•    Minimum of 8+ years’ experience in a clinical vendor management/contracts execution 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, influence stakeholders and drive results.  

EDUCATION:  •    Bachelor’s Degree or equivalent experience •    MBA or other related business experience is a plus (business acumen – translating operations into business benefit •    Process improvement, lean, six sigma experience desirable  

Additional Information

The Head of Clinical Contracts Delivery is responsible for ensuring that vendor contracts in support of all global clinical trials operationalized by Global Clinical Operations (GCO) are in place with all vendors on time so as not to impact program/study milestone delivery, ensuring both Good Clinical/Lab Practices as well as financial compliance throughout