Global Toxicology Director - Nonclinical Strategy

BioSpace; London (OH); On-site; USD 204,000 - 306,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Discretionary bonus

Job summary

Jazz Pharmaceuticals seeks a Director of Toxicology to lead global nonclinical regulatory toxicology for assigned portfolio products. The role involves coordinating CROs, interpreting toxicology data, and shaping regulatory strategies from early development to NDA/BLA submissions.

The candidate will contribute to cross-functional teams, ensure GLP/non-GLP study design quality, and liaise with Regulatory, QA, Clinical, and Drug Safety. A Ph.D.

Qualifications

• Ph.D. in Toxicology or related field; pharma industry experience required.
• Board certification such as DABT desirable or eligible.
• Experience authoring nonclinical sections for IND/CTA/BLA submissions.
• Strong knowledge of FDA/EMA/ICH guidance and GLP regulations.
• Experience managing CROs and cross-functional drug development teams.

Responsibilities

• Lead and manage global nonclinical regulatory toxicology strategy.
• Design/monitor toxicology studies with CROs and ensure timely deliverables.
• Prepare nonclinical sections for regulatory submissions (IND/CTA/BLA).
• Interpret data, define PK/PD correlations, and support decision-making.
• Provide toxicology input to cross-functional project teams.
• Maintain up-to-date knowledge of regulatory guidelines and literature.
• Collaborate with Regulatory, Quality, Clinical, and Safety teams.
• Contribute to SOPs, WI templates, and departmental processes.

Skills

Toxicology expertise

Leadership

Cross-functional collaboration

Regulatory strategy

CRO management

Scientific writing

Education

Ph.D. in Toxicology or related field

Board certification desirable (e.g., DABT)

Job description

Jazz Pharmaceuticals seeks a Director of Toxicology to lead global nonclinical regulatory toxicology for assigned portfolio products. The role involves coordinating CROs, interpreting toxicology data, and shaping regulatory strategies from early development to NDA/BLA submissions.

The candidate will contribute to cross-functional teams, ensure GLP/non-GLP study design quality, and liaise with Regulatory, QA, Clinical, and Drug Safety. A Ph.D.