Assoc Dir Clin Safety Scientist

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Job description

Job Title: Associate Director - Clinical Safety Scientist

Job Schedule: Candidate must be local and able to go into office 1-2 days a week.

Global Travel 20% of Time

Pay rate: $85.71 - $100/Hr.

Responsibilities & job details.

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 Authorisation 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 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

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