Associate Director, Safety Analysis Scientist

We are seeking an Associate Director, Safety Analysis Scientist (SAS) located in Raritan, NJ;
Titusville, NJ; or Horsham, PA. This hybrid position requires onsite presence three days a week.

Product Safety

Product Safety Risk Management

Scientific/Technology

Horsham, Pennsylvania, United States of America

Raritan, New Jersey, United States of America

Titusville, New Jersey, United States of America

The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), the AD SAS prepares scientific safety analysis and evaluations required for regulatory compliance and supports safety-related decision making for marketed products and products in development.

• Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and revision.
• Ensure high quality safety evaluations and reports with minimal stakeholder comments.
• Provide input and review of key regulatory or clinical documents.
• Demonstrate leadership in the Safety Management Team (SMT) and support the MSO.
• Support SMT activities such as preparing and presenting data, compiling meeting minutes, and updating signal tracking information.
• Lead proactive safety data reviews and create a safety position across Global Medical Safety (GMS) for aggregate safety reports.
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Assume responsibility for novel projects, creating value and innovating without defined processes.
• Lead cross‑functional training of relevant stakeholders.
• Act as product or process subject‑matter expert (SME) for audits/inspections.
• Participate in or lead department and/or cross‑functional initiatives.
• Explore innovative ways of presenting data, preparing reports, and improving efficiencies.
• Assist Directors in the creation, review, and implementation of controlled documents and related tools.
• Manage unscheduled reports within the Aggregate Report Calendar.
• Manage activities within smaller therapeutic areas, as applicable.
• Line‑manage contractor positions within the team, as applicable.
• Act as backup to the Therapeutic Area Lead (TAL) as needed.
• Oversee deliverables by other team members, such as complex reports, as needed.

• Bachelor’s Degree in Healthcare‑related or Biomedical Science (11+ years industry experience or equivalent).
• Advanced Degree in Healthcare‑related or Biomedical Science (8+ years industry experience or equivalent).

• Medical writing or Pharmacovigilance (PV) experience.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post‑marketing and global safety health authority requirements.
• Ability to understand and analyze complex medical‑scientific data from a broad range of disciplines.
• Ability to interpret and present complex data to determine benefit‑risk impact.
• Excellent English verbal and written communication skills.
• Ability to effectively interact with stakeholders, including business partners.
• Ability to work in a matrix environment, proven leadership skills.
• Ability to plan work to meet deadlines and effectively handle multiple priorities.
• Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
• Ability to independently influence, negotiate and communicate with internal and external customers.

• Clinical experience.
• Oncology experience.

The anticipated base pay range for this position in the United States is $137,000 to $235,750.

Employees and/or eligible dependents may be eligible to participate in the following company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)).

Time‑off benefits include: vacation (up to 120 hours per calendar year); sick time (up to 40 hours per…