Associate Director Clinical Safety

Job Title: Associate Director Clinical Safety Scientist

Duration: 12+ Months (Possibility of extension & conversion)

Location: Basking Ridge, NJ [HYBRID]

Job Schedule: Candidate must be local and able to go into office 1-2 days a week. Global Travel ~ 20% of Time

Job Description:

• This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product lifecycle.
• Collaborates with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's workload, anticipates potential issues and works towards resolving issues, and escalates and communicates issues, as appropriate.
• Oversees or leads the coordination of Safety Management Team (SMT)/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the PSL.
• Independently evaluates safety data of any source to identify potential safety signals and performs 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.
• Oversees or tracks safety signals in the global electronic signal tracking tool.
• Collaborates with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country submissions.
• Collaborates 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

Skills:

• 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 guidance.
• 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

Keywords:

Education:

• 3-5 years of proven experience with an advanced degree required
• 6-9 years of experience with a bachelor's degree required

Skills and Experience:

Required Skills:

• Product Lifecycle
• Safety Management
• SMT
• Marketing
• Surface Mount Technology
• Additional Skills:
• Excel
• Project Management
• Microsoft Powerpoint
• Trading
• Subject Matter Expert
• Microsoft Word
• Safety Analysis
• Clinical Safety
• Mentors

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