Associate Director Clinical Safety Scientist

3 weeks ago

Basking Ridge, United States The Fountain Group Full time

Details for the position are as follows:

  • 12-month contract.
  • Hybrid role in Basking Ridge, NJ. Candidate must be local and able to go into office 1-2 days a week.
  • Global Travel ~ 20% of Time (travel to Spain; Germany; Amsterdam; & Japan)
  • Rate: $85- 100 hr depending on experience level and education.

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 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

Required Skills:

  • Education Qualifications (from an accredited college or university)PharmD preferred PhD preferred Bachelor's Degree required
  • 3-5 years of proven experience with an advanced degree required
  • 6-9 years of experience with a bachelor’s degree required
  • 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

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