Clinical Safety Scientist Lead
6 days ago
We are seeking an experienced Clinical Safety Scientist to lead our safety surveillance and risk management efforts for a large, late-stage program or multiple early-stage programs. The successful candidate will work closely with our Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team to proactively identify and mitigate potential safety risks throughout the product lifecycle.
Key Responsibilities- Collaborate with the PSL(s) to plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, overseeing teams workload, anticipating potential issues, and working towards resolving issues, and escalating and communicating issues, as appropriate.
- Oversee or lead the coordination of Safety Management Team (SMT)/Product-level safety meetings, maintain roster, calendar, and minutes, and communicate materials, in support of the PSL.
- Independently evaluate safety data of any source to identify potential safety signals and perform safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including SMT or other cross-functional teams.
- Oversee or track safety signals in the global electronic signal tracking tool.
- Collaborate with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country submissions. Collaborate with PSL/Clinical Safety Physician(s) and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach of safety sections of the submission dossier, where applicable, and to ensure timelines and business objectives are met.
- Subject matter expert (SME) in 2 or more focus areas.
- May supervise a team of Clinical Safety Scientists for assigned product(s), or serve as a preceptor for post-doctoral fellows. Provides guidance, and mentors and coaches junior Clinical Safety Scientists.
- Clinical development or post-marketing experience to be able to apprehend safety context through the product lifecycle.
- Understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
- Ability to engage team and cross-functional team members to facilitate continuous flow of information to meet business objectives.
- Manages conflict and negotiates constructively.
- Ability to develop and build healthy working relationships to enable higher performance.
- Effective oral and written communication skills.
- Demonstrated ability to handle more than one complex project simultaneously, prioritizing and recognizing key issues.
- Demonstrates effectiveness in working in a multidisciplinary and matrixed environment.
- Understanding of tools, standards, and approaches used to efficiently evaluate safety is desirable.
- Microsoft Word, Excel, PowerPoint skills, and Project management skills.
- Able to work independently with minimal direct supervision.
- 3-5 years of proven experience with an advanced degree required.
- 6-9 years of experience with a bachelor's degree required.
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