Arvinas is hiring a
Associate Director

Summary

The job is for an Associate Director of Outsourcing in a clinical-stage biotechnology company named Arvinas. The role involves supporting and developing processes related to outsourcing, mentoring staff, and assisting senior management. The position requires 8+ years of Clinical outsourcing experience within the pharmaceutical/biotech industry.

Requirements

• 8+ years of Clinical outsourcing experience within the pharmaceutical/biotech industry
• Advanced knowledge of contract research costing, ability to analyze written proposal and cost models
• Strong organizational and communication skills
• Strong negotiation skills with ability to analyze and assess specific situations/issues
• Knowledge and understanding relating to budget impacts of various changes in study parameters
• Strong spreadsheet skills, knowledge or contract language and understanding of the industry
• Experience building/maintain budgets/forecasts
• Experience interacting with a wide range of suppliers, initiating, negotiating and executing financial terms in the clinical trials environment- biotech or pharmaceutical industry
• Experience managing RFPs and summarizing bids for presentation to teams & management for consideration
• Specific experience in negotiating Discounts/Rebates reviewing vendor rate cards
• Experience in reviewing PI Site budgets is a plus
• Experience with creating/processing Purchase Orders including Change Orders associated workflows and approvals
• Proven experience in managing key internal and external stakeholders effectively
• Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts
• Detail focus and ability to sustain high levels of performance in a constantly changing environment
• Knowledge of GCP, Sunshine Act, GDPR, and other industry standards

Responsibilities

• Supports Clinical, Clinical Pharmacology, and Nonclinical outsourcing requirements
• Assists and/or manages Requests for Proposals (RFPs) in support of outsourcing objectives
• Mentors and trains Outsourcing staff
• Reviews and evaluates vendor budgets performing comparison and analysis functions
• Develops and reviews Statements of Work (SOWs) to meeting necessary scope and quality requirements and to ensure optimal contractual terms and conditions
• Assists with the coordination of vendor identification, selection, governance, and oversight
• Ensures contracts, budgets, change orders, etc. have been uploaded to Arvinas folders and disseminated to the appropriate parties
• Helps track vendor projects to generate outsourcing metrics and KPIs as required
• Assists with maintaining and updating financial planning and forecasting tools, files, and systems including the use of software tools such as ClearTrials
• Participates in study team meetings and vendor meetings as needed
• Assists with the development and improvement of templates including RFPs, Project Contracts, Master Services Agreements, as well as financial tracking and invoicing format/tools
• Attends and participates in clinical team meetings to review vendor performance and update project specifications in association with ongoing contractual management and invoice approval process
• Assists with the tracking on study/project budgets i.e., budgeted vs actual
• Ensures Purchase Orders are approved and aligned with each contract
• Assists with the execution of the business’ sourcing strategy across all functions involved in execution of the company’s development strategy
• Assists or develops efficient processes for vendor relationship and management of company’ major clinical service providers as needed or requested
• Assists with driving outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, company’s outsourcing and procurement policies and procedures
• Serves a process leader and subject matter expert related to outsourcing processes and supports the Senior Director in achieving Outsourcing goals and objectives
• Provides operational expertise and strategic leadership, support, guidance, and training to clinical teams on all aspects of outsourced work

Benefits

• Group medical, vision and dental coverage
• Group and supplemental life insurance