Clinical Safety Scientist Lead

5 days ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

Job Summary:

We are seeking a highly skilled Clinical Safety Scientist Lead to join our team at BioSpace, Inc. in the Oncology department. As a key member of our team, you will be responsible for proactively performing safety surveillance and risk management in partnership with Product Safety Leads, Clinical Safety Physicians, and cross-functional teams to support the benefit-risk profile throughout the product life cycle.

Key Responsibilities:

  • Develop and implement safety strategies, key safety messages, and review and author safety sections of Common Technical Documents (CTDs).
  • Collaborate with Product Safety Leads and cross-functional teams to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country submissions.
  • Oversee or lead the coordination of Safety Management Teams (SMTs)/Product-level safety meetings, maintain rosters, calendars, and minutes, and communicate materials in support of Product Safety Leads.
  • 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 assessments to appropriate forums, including SMTs or other cross-functional teams.
  • Oversee or track safety signals in the global electronic signal tracking tool.
  • Collaborate with Product Safety Leads and Clinical Safety Physicians to review and revise Clinical Study Protocols (CSPs), Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents.
  • Authors or oversees the development of safety sections of Investigator's Brochures, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheets (CCDS), Risk Management Plans (RMPs).
  • Collaborate with Product Safety Leads and cross-functional teams to author or contribute to regulatory authority requests or communication.
  • Ensures consistent and unified safety message throughout multiple documents.

Requirements:

  • PhD preferred. Bachelor's degree in healthcare 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 life cycle.
  • Understanding of Safety Risk Management internal and external environment, including applicable regulations and guidance's.
  • Manages conflict and negotiates constructively.
  • Ability to develop and build healthy working relationships to enable higher performance.
  • Demonstrated ability to handle more than one complex project simultaneously, prioritizing and recognizing key issues.
  • 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.

Global Travel: 20% of Time

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