Associate Director, Business Development Execution - Global Regulatory Affairs & Clinical Safety

Job Description

Under minimal guidance of the Senior Director, Business Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.  These agreements include but are not limited to divestitures, mergers/acquisitions, in-licensing, out-licensing, collaborations, co-marketing, and authorized generic agreements.  Facilitates the processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance.

Work closely with the Corporate Business Development, our Research & Development Division Global Alliance Management (MGAM), Integration Management Office (IMO) and GRACS Business Development to understand the partner agreements and the goals of those agreements throughout the lifecycle post signing. 

Responsible for establishing the GRACS Integration or Transition Team (comprised of functional Subject Matter Expert (SME)) through the recruiting and onboarding integration team members upon completion of the due diligence and understanding of the contract execution requirements for the deal.

Performs all responsibilities of the GRACS Business Development Execution Lead (or GRACS Integration Lead or Transition lead) including facilitation of discussions with GRACS Functional execution team to identify gaps and risks, track progress and coordinate ongoing updates of progress to ensure GRACS Leadership is informed as needed.  Responsible for understanding contracts and working closely with the Corporate Business Development and our Research & Development Division Alliance Management Teams

Following the GRACS Business Development Operating Model and related tools, kick off, charter and facilitate deal-specific GRACS Integration Team comprised of functional area representatives from the impacted functions/processes.  Responsibility will include (a) utilizing project management tools to drive development of deal implementation project plans; (b) identifying & ensuring cross-functional alignment of interdependent activities; and (c) driving execution of the plans through to project close-out.

Assess GRACS Integration/Transition related problem situations to identify causes, gather and process relevant information, generate possible solutions, make recommendations and/or resolve the problem and direct the resolution of complex business problems through the GRACS Business Development Forum.

Where an ongoing relationship is maintained with the business partner, the incumbent will be responsible for serving as the point of contact for all alliance management issues including contractual questions related to ongoing GRACS activities and as required, lead execution and support of ancillary agreement creation, including Ways of Working alignment.  Review project details, update and track business development related communications within the Business Development Lifecycle Management system.

Education:

• BS Degree preferably in technical, business or science.

Required Experience:

• At least 8 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance Management.

• Understanding of regulatory and clinical processes for pharmaceutical products, vaccines and/or biologic products.  Working knowledge of regulatory concepts, requirements, and overall process of product lifecycles

• Strong virtual and in person collaboration

• Demonstrated facilitation and leadership skills.

• Clear communicator and goal oriented.

• Comfort and experience building and presenting effective slide presentations with audiences at all levels of the organization.

• Independent thinker and worker.  Highly organized, motivated, and detail-oriented while still able to keep overall "big picture" view of projects and strategies.

• Demonstrated analytical and data management skills.  Experience pulling together abstract milestones and data into centralized management report.

• Demonstrated ability to lead cross functional teams and facilitate cross functional meeting to achieve a purpose.

• Strong, demonstrated project management capabilities and skills.  Ability to collaborate and manage multiple projects at various stages of the process simultaneously.

• Ability to communicate messages in a clear and concise manner both verbally and in writing. Experience with change management concepts and execution. 

• Strong pro