Assoc Dir Clin Safety Scientist

HireTalent; Basking Ridge (NJ); Hybrid; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking an Associate Director of Clinical Safety Scientist to lead safety surveillance for innovative clinical programs. This pivotal role involves collaborating with cross-functional teams to ensure effective risk management throughout the product lifecycle. The ideal candidate will have extensive clinical development experience and the ability to mentor junior scientists while managing complex projects. Join a dynamic environment where your expertise will directly impact patient safety and product success, and enjoy the opportunity for global travel and professional growth.

Qualifications

• Experience in clinical development and safety context through product lifecycle.
• Ability to engage cross-functional teams to meet business objectives.

Responsibilities

• Lead safety surveillance and risk management for clinical programs.
• Oversee safety data evaluation and contribute to safety action recommendations.

Skills

Clinical development experience

Safety Risk Management knowledge

Effective communication skills

Project management skills

Ability to handle complex projects

Education

Degree in Life Sciences

Post-doctoral experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Title: Assoc Dir Clin Safety Scientist

Job Schedule:

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

*Please see attached for further responsibilities & job details.

Responsibilities:

1. 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.
2. 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.
3. 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.
4. 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.
5. Oversees or tracks safety signals in the global electronic signal tracking tool.
6. 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.
7. Subject matter expert (SME) in 2 or more focus areas.
8. May supervise a team of Clinical Safety Scientists for assigned product(s), or serve as a preceptor for post-doctoral fellows.
9. Provides guidance, and mentors and coaches junior Clinical Safety Scientists.

Qualifications:

• Clinical development or post-marketing experience to understand 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.
• Ability to work in a multidisciplinary and matrixed environment.
• Understanding of tools, standards, and approaches used to evaluate safety is desirable.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Project management skills.
• Able to work independently with minimal supervision.