Associate Director Clinical Safety Scientist

Target Pay Range: 85-92/hr
*depending on experience
Summary
• This position will proactively perform safety surveillance and risk management for assets in early/late stage clinical development, as well as post-marketing, in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product lifecycle
• Perform routine safety surveillance and risk management activities for assets in the early and/or late stage of clinical development as well as post-marketing.
Works collaboratively with other safety scientists and safety physicians to support the coordination of Safety Management Team (SMT)/Product-level safety meetings deliverables, 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) and scientist lead 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).

Responsibilities

· Risk Management (Signal identification, evaluation, mitigation):

o Support 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), safety scientists and cross-functional team in support of benefit risk profile throughout product lifecycle

o Develops materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetings, including recommended safety actions, and communication and risk minimization plans

o Authors or oversees the development of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs), for assigned product(s)

o Authors or oversees the development of the Safety Management Plan for assigned product(s)

o 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

o Oversees or tracks safety signals in the global electronic signal tracking tool

· Safety Communication:

o Collaborates with PSL(s) or Clinical Safety Physician(s) for assigned product(s) or clinical studies to review and revise CSPs, 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

o Authors or supports the development of safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)

o Collaborates with PSL(s) and cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communication

o Ensures consistent and unified safety message throughout multiple documents

· CTD submissions/Others:

o 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 support multiple simultaneous submissions to ensure timelines and business objectives are met

o Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed

o Acts as audit/inspection Subject Matter Expert (SME) for safety surveillance and risk management for assigned product(s), through inspection readiness preparation, and may serve as the primary or back-up SME, and may collaborate with team on CAPAs, including CAPA responses and approvals

· Project Management:

o Collaborates with the PSL(s) and scientist lead to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), anticipates potential issues and works towards resolving issues, and escalates and communicates issues, as appropriate

o Supports the coordination of Safety Management Team (SMT)/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the PSL

o May oversee multiple simultaneous complex projects to ensure timelines and business objectives are met

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)PharmD preferred PhD preferred Bachelor's Degree required Experience Qualifications

· 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 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