Associate Director, Cell Therapy Senior Patient Safety Scientist - Oncology

Role Summary

Associate Director, Senior Patient Safety Scientist to join our Patient Safety department in the Cell Therapy Oncology/Haemato-oncology Therapeutic Area. You will lead safety strategy for assigned cell therapy study/projects, collaborate cross-functionally, train junior colleagues, and contribute to safety documentation and regulatory inputs.

Responsibilities

• Lead aggregated review, analysis, and interpretation of safety data to support safety decision-making for study/project teams, patients, prescribers, and payers.
• Lead safety documentation across safety surveillance, signal evaluation, periodic reports, and regulatory inputs, including health authority responses and safety content of MAAs/BLAs.
• Contribute to delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned assets.
• Deliver clinical safety strategy for assigned cell therapy study/projects; collaborate with Global Safety Program Lead, Safety Physician, and other Patient Safety Scientists.
• Provide training and coaching to junior colleagues; facilitate cross-functional interactions across functions and geographies.

Qualifications

• Required: Bachelor‚Äôs degree in sciences/pharmacy/nursing or related field with relevant experience, or advanced degree with relevant experience.
• Required: Experience in Patient Safety and/or Drug Development activities in at least 3 areas (e.g., early/late-phase clinical drug development safety strategy, post-marketing surveillance, safety reporting, risk management plans, governance interactions, PV regulations in US/EU/UK, ICH guidelines).
• Required: Ability to handle multiple projects, operate in an advanced matrix structure, and fluent written and spoken English.

Preferred Qualifications

• MSc/PhD/PharmD in scientific discipline.
• CGT product development and CGT safety monitoring experience.
• Advanced understanding of pharmacoepidemiology.
• Experience with AI tools (e.g., ChatGPT, Claude, LLMs, Agentic AI).
• Knowledge of PV regulations in China, Australia, Japan, rest of Asia.

Skills

• PV, oncology, and cell therapy domain knowledge.
• Safety strategy development, signal evaluation, and regulatory writing.
• Cross-functional collaboration and stakeholder management.

Education

• Bachelor‚Äôs degree in sciences/pharmacy/nursing or related field; advanced degree preferred.

Additional Requirements

• Location: Gaithersburg, MD, USA.