Director, Safety Science Program Management
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This position reports into the Office of the Product Safety Team (PST) department in the Pharmacovigilance and Patient Safety (PPS) organization’s Strategic Operations. 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 Director, Safety Science Project Management plays a critical role in shaping and driving the strategic priorities of Safety Science through providing exceptional strategic project management leadership across the PST. 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.
This role reports to the leader of the Safety Science Program Management organization and supports the leader with people management, project management functions within the PST, and Office of the PST (OOPST) strategic initiatives.
- Provides oversight, leadership, and strategic direction to the Safety Science project management function within the Product Safety Team (PST), and OOPST strategic initiatives.
- Supports the development and implementation of the vision, strategy and objectives of the project management functions within the Product Safety Team (PST), and OOPST strategic initiatives.
- Support responsibilities for hiring, coaching, training, onboarding, and managing the performance of PST Program Managers. Responsible for building and nurturing a culture of strong project management excellence across assigned PM teams.
- Builds strong strategic partnerships with all Safety Science project management stakeholders including Therapeutic Area Heads, PST Leads, BRM and Epi Heads and other stakeholders (within and outside PPS). Seeks their input to shape priorities for the project managers and leverages relationships to advance the goals of the team. Ensures successful partnership between the assigned project management functions, PST Operational Excellence teams and the PSTs.
- Ensures that the assigned PMs are appropriately resourced. Collaborates with the Safety Science Program Management leader to plan and forecast the use of PST PMs across product safety teams. Seeks creative ways to utilize limited resources and works with Sr. Director Office of the PST to address critical resource needs
- Responsible for achieving quality and timely metrics for PST and assigned teams. Collaborates with the Safety Science Program Management leader to understand root causes of quality and timeliness issues. Accountable for ensuring that root causes are addressed within the appropriate PM team.
- Partners with the Safety Science Program Management leader to define the readiness plan for inspections and audits. Represents the PST PM team on audit and inspection teams, when required.
- Promotes project management best practice and knowledge sharing across Safety Sciences Project Management functions and with other AbbVie Project management teams such as the Portfolio Project Managers (PPMs).
- Drives assigned critical OOPST leadership initiatives including complex Portfolio Oversight Committee projects that are critical to the success of the PSTs.
- Manages Product Safety Teams as assigned. Represent the PST Lead and PST decisions in committees/meetings.
- Supports and coaches PMs in addressing challenges that arise on the PSTs or other project teams, including navigating difficult decisions.
- Bachelor’s degree in a healthcare discipline (i.e.: Life Science, Pharmacy, nursing [associates or equivalent] or healthcare profession, or biomedical disciplines)
- Masters or advanced degree is desirable
- 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
- 9+ years hands-on project management experience in leading cross-functional projects within a global matrixed organization. Hands-on experience applying project management tools and templates
- Required experience in at least two R&D areas such as clinical study management, regulatory, drug safety, discovery, etc.
- Preferred leadership and people management experience. Experience in directly leading and driving major change initiatives within a team. Strong leadership presence and demonstrated ability in courageously challenging the status quo and influencing others. Experience in working directly with and influencing senior management including functional heads
- High emotional Intelligence and strong relationship management and communication skills
- Understanding of the connections between regulations and science for the benefit of drug safety
- Understanding of tools, standards and approaches used to efficiently evaluate drug safety, is desirable but not required
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.