Director, Development Business Ops - Clinical Outsourcing
We are currently seeking a Director, Development Business Operations with expertise in clinical outsourcing of Development services. The role is responsible for leading process excellence efforts in support of the entire life cycle of vendor selection, including RFI, RFP, vendor selection decision, contracting, monitoring performance, managing the change order process, and ensuring proper closeout of clinical vendor agreements. The candidate will lead a team with specific ownership of vendor qualification, inspection readiness, and continuous improvement. The candidate will have a proven success record of working in a matrixed environment, and regularly collaborating with cross functional teams, such as, clinical operations, technology & innovation, regulatory, safety, quality, compliance, finance, legal, business conduct, and vendor management. In addition, the role will have excellent communication skills and is comfortable interacting with internal and external teams of all levels, including Senior Management. This position will require the ability to apply critical thinking in centralized operational performance and improvement in clinical vendor outsourcing, contract management and budget development including negotiation and drafting expertise, in a high volume, fast paced environment. The ideal candidate will have strong managerial skills with demonstrated success in managing multiple direct reports and works collaboratively with other cross functional groups to drive a culture of continuous improvement and ensure operational readiness.
- Leads a centralized team to support Clinical Development Vendor Outsourcing operations
- Leadership of the vendor qualification process, ensuring that new vendors are capable of meeting clinical development needs
- Lead Inspection Readiness activities, helping to ensure a total quality mindset which results in greater customer satisfaction and seamless audits
- Drive a culture of continuous improvement by leading a centralized effort to generate, prioritize and implement process improvement ideas
- Delivers value by translating stakeholder requirements into effective sourcing solutions, contractual terms and process improvements
- Ensure the vendor selection process is compliant by managing risks through benchmarking, rate negotiations, implementing the sourcing strategy, collaborating with cross functional teams such as Compliance, Legal and Regulatory
- Leverages internal and external benchmarking data, industry best practices and innovative technology
- Identifies new vendor opportunities by providing high impact / optimized solutions through the category management process and generates new ideas for business solutions and new process/technology by incorporating patient input into clinical development
- Is an SME in resolving complex issues relating to contract negotiation and management
- Negotiates with and influences others internally and externally, with great latitude on outcomes
- Across Development, connect with multiple business departments on sensitive vendor negotiation requirements, oversight and strategy
- Demonstrated ability to make critical decisions related to clinical vendor agreement negotiations and escalations
- Pulls data across functions according to business requirements and recommends global development vendors to senior leadership for endorsement for projects
- Asks probing questions to uncover business needs and recommends solutions (e.g., negotiating timelines while maintaining standards)
- Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols
- Identifies operational and systematic issues, including frequency and escalates to the appropriate level
- Provides recommendations to senior management and provides input into the overarching sourcing strategy
- Owns team retention and development strategy and enables talent visibility and mobility across Development
- Is accountable for the global performance and results of related areas
- Provides guidance based on organizational goals and company policy
- Establishes operating policies and procedures
- Collaborates across departments to set the standards for high-performance and communicates across the teams
- Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance
- Embraces a customer-centric mindset to help translate needs into solutions
- Develops solutions to a wide range of complex problems which require a high degree of ingenuity, creativity, and innovation.
- Challenges are unique and solutions may serve as precedent for future decisions.
- Thinks outside of the box by turning constraints into solutions by working with stakeholders
- Develops immediate flexible sourcing strategies and mitigates risk through contingency or alternate solutions in response to supplier performance issues
- Serves as a strategic enabler for continuous improvement of processes and systems to drive efficiencies and growth for a full category
- Creates feedback mechanism to distill lessons learned and develops action plans to rollout solutions across departments
- Supports strategic pillars of transforming clinical trials, enables flexible and scalable operating model by continuously and proactively surveying the marketplace and internal stakeholders needs to leverage emerging trends and technologies
- Develops and manages new standards supporting vendor governance that can apply across the portfolio of one or more categories
- Develops and implements inspection readiness strategy in collaboration with functions across Development (e.g., oversees inspection preparation and responses)
- Enables new data sources and technologies to modernize study design and conduct
- Executes departmental business plans and contributes to the development of departmental strategy
- Ability to drive value and deliver the expected ROI (cost containment/reduction, cycle time reduction quality, etc.) and business results through oversight and change management across several categories
- Deliver process improvements that drive value across multiple drivers (cost, cycle time, efficiency, quality/compliance, stakeholder experience, etc)
- Drive a total quality mindset that ensures stellar performance in audits and inspections
- Ability to drive and steer change and decisions through quality of advice (e.g., influencing the sourcing strategy by recommending a new or existing vendor upon department request)
Capabilities and Requirements
- Experience in providing thought leadership, consistent customer service, clinical vendor outsourcing operational oversight and inspection readiness excellence
- Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management.
- Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions.
- Demonstrated leadership skills while working in fast paced and changing environment
- 10+ years of experience with a BA in a relevant discipline
- 8+ years of experience with a MS/ MBA in a relevant discipline
Preferred Education & Certifications
- Finance / business / science / medical-related degree
- MS/MBA or JD
- Project management certification (e.g., PMP)
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