Associate Director, GRACS BD

• Represent Global Regulatory Affairs and Clinical Safety (GRACS) on business development transactions from deal initiation through potential signing and transition execution support
• Manage GRACS activities across strategy, evaluation, due diligence, contracting, and implementation support
• Partner with GRACS functional areas, Business Development, Clinical Research, Legal, and Alliance Management
• Support drafting, negotiation, execution, and maintenance of master agreements and regulatory agreements
• Coordinate and conduct due diligence across GRACS functional areas
• Recruit and onboard due diligence team members
• Facilitate discussions to identify gaps and risks
• Track progress and coordinate GRACS due diligence summary reports
• Ensure GRACS Leadership is informed of critical due diligence findings
• Liaise with GRACS Portfolio and Prioritization to support resource estimation
• Review commercial contracts and negotiate GRACS-related contract language with partners
• Charter and manage deal-specific GRACS implementation teams
• Develop implementation project plans using project management tools
• Identify and align interdependent cross-functional activities
• Drive implementation plans through project close-out
• Serve as point of contact for alliance management issues and contractual questions
• Lead execution and support of ancillary agreement creation
• Conduct or oversee ongoing partner diligence
• Update BD projects and contracts in the Business Development Lifecycle Management system

• Bachelor's Degree
• Experience managing GRACS activities across business development stages including strategy, evaluation, due diligence, contracting, and implementation support
• Experience supporting acquisitions, licensing, and collaborations
• Experience drafting, negotiating, executing, and maintaining master agreements, regulatory agreements, amendments, side letters, and other contractual forms
• Experience coordinating and conducting due diligence with functional subject matter experts
• Experience reviewing commercial contracts and negotiating GRACS-related contract language
• Experience chartering and managing cross-functional implementation teams
• Experience with alliance management and ongoing partner diligence
• Knowledge of FDA Regulations
• Agreement Management
• Business Development
• Change Management
• Clinical Leadership
• Contract Processing
• Cross-Functional Project Management
• Data Management
• Partner Relationship Management (PRM)
• Pharmacovigilance
• Project Management Methodology and Tools
• Project Planning
• Project Resource Management

Demonstrates expertise in managing Global Regulatory Affairs and Clinical Safety activities throughout business development stages, including due diligence, contracting, and implementation support. Proficient in drafting and negotiating various agreements while ensuring compliance with FDA regulations and effective alliance management.

• Business Development
• Due Diligence Coordination
• Contract Negotiation
• Cross-Functional Project Management
• FDA Regulations Knowledge

• Agreement Management
• Contract Processing
• Project Planning
• Data Management
• Pharmacovigilance

• Clinical Leadership
• Change Management
• Partner Relationship Management

• Project Management Methodology and Tools
• Business Development Lifecycle Management System