Associate Director, Product Safety Team Project Management

This position reports into the Office of the PST (part of the Strategy Management Office) in the Pharmacovigilance and Patient Safety (PPS) organization. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.

The Product Safety Team Project Management group (PST PM) plays a critical role in shaping and driving the strategic priorities of the PST through providing exceptional and strategic project management leadership. The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative safety-driven strategies, which will maximize product benefit-risk for patients.


Key Responsibilities Include:

• In partnership with PST Lead, shape the PST strategic priorities and drive implementation by applying strong understanding of Therapeutic Area, regulatory science, signal management & project management to influence characterization of the compound/product safety & effectiveness profile. This responsibility will be accomplished through building and nurturing strong and trusted relationship with PST Lead.
• In partnership with the PST Lead, manage multiple complex Product Safety Teams across multiple Therapeutic Areas and across all phases of the product lifecycle. This includes meeting planning and facilitation, meeting minute documentation and post-meeting/general team management activities. Increase meeting productivity and advance decision-making effectively through the application of strong skillsets in strategic thinking, influence, leadership, relationship building, proactive-ness, curiosity and active engagement. Mentor, coach and train less experienced PST PMs.
• Proactively utilize experience and knowledge to support the PST Lead in framing safety issues and making decisions. Anticipate possible outcomes of safety issues and provide guidance to the PST Lead so that he/she can be proactively prepared. Systematically analyze the impact of safety decisions and connect the dots across other decisions, discussions and actions across the organization. Communicate perspectives to PST Lead and recommend solutions.
• In partnership with PST Lead, manage escalation of safety issues and decisions to management and Safety Review Board (SRB). Create escalation documentation (e.g. SRB presentations) and help prepare the PST Leads for discussions. Manage the close-out of SRB action items for assigned PSTs.
• Support the PST Lead in strengthening internal partnership/influence and establish role as the company leader of safety issues related to their compounds/products. Identify new opportunities for the PST Lead to build relationships and present thought leadership to peers. Identify and share best practices that other PMs can adopt to support their PST Leads. Represent the PST Lead and PST decisions in other committees/meetings.
• Support the PST Lead in strengthening external engagement/presence by providing recommendations on channels for expanding external engagement including topic ideas for publications, conferences to present at, key industry relationships to develop, etc. Provide significant contributions to the creation of content for external engagement activities.
• Proactively promotes best practice and knowledge sharing process PSTs. Shares PST best practices with other PM teams across AbbVie and seeks to learn and adopt their best practices. Acts as a champion within the PST PM organization and mentors other PMs to adopt best practices. Provides coaching and training on process excellence tools, skills, mindset, ways of working and behavior. Champion continuous improvement opportunities for the PST to establish agile and high performing PSTs.
• Drive timely development of key PST deliverables by planning and facilitating productive working sessions to create deliverables; share perspectives; push the thinking to create robust deliverables, suggest improvements and connect the dots.
• Drive inspection/audit readiness activities and act as a subject matter expert during inspections/audits. Engage in leading and addressing PST-related inspection/audit activities and leading CAPAs/commitments.
• Endure safety deliverable timeliness and quality levels are met through addressing alignment, consistency and data integrity.

Basic:

• Bachelor's degree in a healthcare discipline (i.e.: Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines), Masters or advanced degree is desirable.
• At least 7 years' hands-on project management experience in leading cross-functional projects within a global company. Hands-on experience applying project management tools and templates.
• At least 7 years' experience working in the healthcare industry and a strong understanding of the drug development process. Experience within Pharmacovigilance is desirable but not required.
• Experience in one of the following areas: clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations
• Understanding of the connections between regulations and science for the benefit of drug safety.
• Understanding the tools, standards and approaches used to efficiently evaluate drug safety is desirable but not required.
• Comprehensive knowledge of the drug development process which includes: conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, Regulatory requirements for submission, product launch and post marketing support.
• Experience in working directly with and influencing senior management including functional heads.
• Demonstrated effectiveness in working in multidisciplinary, matrix team situation and demonstrated ability to manage change.
• Proven leadership and communication skills that minimally include: Effective and timely communication of project objectives, issues/risks as well as other project information required to keep the team and management informed.
• Ability to adapt in a quickly changing environment, ability to engage team members across functions to facilitate information sharing in order to maintain a continuous flow of information; capability to clearly present, influence and logically justify positions/proposals; sound judgment; manages conflict and negotiation constructively; ability to develop build strong working relationships to enable high performing teams.