Associate Director, Safety Analysis Scientist

The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD SAS, partnering with the Medical Safety Officer (MSO), prepares and evaluates scientific safety analyses required for regulatory compliance and to support safety‑related decisions for marketed and development products. The AD SAS supports Safety Management Teams (SMTs), collaborates with cross‑functional safety partners to define product safety strategy, completes safety analyses and evaluations, proactively reviews safety data, leads safety data review meetings, interprets safety information to recommend actions, and supports SMT deliverables. The AD SAS assists the MSO with SMT activities and key safety and clinical documents, serves as product point of contact, provides training, and oversees deliverables by other team members when needed. Acting independently, the AD SAS efficiently delivers high‑quality outcomes with minimal guidance, builds alliances, and influences safety partners to shape decisions.

Responsibilities:

• Lead safety evaluations, including strategy discussions, data retrieval, analysis, report writing, and revisions.
• Ensure high quality safety evaluations and reports with minimal stakeholder comments.
• Provide input and review of key regulatory or clinical documents as appropriate.
• Demonstrate leadership in the SMT and support the MSO.
• Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Lead proactive safety data reviews and contribute a safety position across Global Medical Safety that can be leveraged for aggregate safety reports.
• Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Assume responsibility for novel projects, create value, and innovate without defined processes; seek guidance from Directors (e.g., SAS TAL) for complex projects.
• Lead cross‑functional training of relevant stakeholders.
• Act as product or process Subject Matter Expert (SME) for audits and inspections.
• Participate in or lead department or cross‑functional initiatives.
• Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs you own.
• Assist Directors in the creation, review and implementation of controlled documents and other 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 TAL as needed (e.g., when Director SAS TAL is unavailable).
• Oversee deliverables by other team members (e.g., complex reports), as needed.

Qualifications / Requirements:

• Education: Bachelor’s Degree in Healthcare‑related or Biomedical Science; 11+ years industry experience or equivalent.
• Advanced Degree Preferred: Healthcare‑related or Biomedical Science; 8+ years industry experience or equivalent.
• Medical writing or Pharmacovigilance (PV) experience required.
• 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 across 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 and demonstrate proven leadership skills.
• Ability to plan work to meet deadlines and handle multiple priorities.
• Proficiency in Microsoft applications (Word, Excel, PowerPoint).
• Ability to independently influence, negotiate, and communicate with internal and external customers.

Experience Preferred:

• Clinical experience preferred.
• Oncology experience preferred.