Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology

AstraZeneca; Gaithersburg (MD); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a senior leader to helm global safety strategy for its Cell Therapy Oncology and Onco-Hematology assets. You will oversee safety management, craft safety plans, and represent safety in governance forums to ensure regulatory compliance and safe development of therapies.

You will mentor junior staff, drive cross-functional collaboration, and travel domestically and internationally as needed. On-site in Gaithersburg with a hybrid work model.

Qualifications

• MD/DO or equivalent in biomedicine/science.
• Extensive clinical safety/pharmacovigilance across pre- and post-approval phases.
• Proven leadership in asset safety strategy.

Responsibilities

• Lead safety strategy for Cell Therapy Oncology and Onco-Hematology assets.
• Oversee safety management teams and develop safety plans including TPP and risk minimization.
• Represent safety in governance forums and ensure regulatory compliance of safety documents.

Skills

Safety leadership

Pharmacovigilance

GVP regulations

Cross-functional leadership

Communication skills

Gene & cell therapies

Education

Medical degree

Clinical safety experience

Job description

Role

Lead global safety strategy for AstraZeneca's Cell Therapy Oncology and Onco-Hematology assets, focusing on benefit–risk assessment and post-marketing safety.

Responsibilities

• oversee safety management teams, develop safety plans including TPP and risk minimization strategies, represent safety in governance forums, ensure regulatory compliance of safety documents, provide strategic guidance to safety teams, and foster cross-functional collaborations
• mentor junior safety staff.

Requirements

• medical degree or equivalent in biomedicine/science
• extensive clinical safety/pharmacovigilance experience across pre-and post-approval phases
• proven leadership in asset safety strategy
• deep knowledge of PV regulations and safety deliverables
• strong matrix leadership and communication skills
• experience with gene and cell therapies
• willingness to travel domestically and internationally

Preferred

• advanced degrees (PhD)
• oncology/haematology expertise
• translational research background
• experience with PV regulations in key Asian markets
• industry conference speaking
• in-licensing support

High-Value

• cell and gene therapy, oncology/haematology indications, late-stage development and post-market phases, regulatory interactions, and safety leadership in biotech/pharma settings.

Work Setup

on-site in Gaithersburg, US, with a hybrid work model (3 days in-office, 2 days remote).