Senior Director, Toxicology Strategy & Submissions

BioSpace; Indianapolis (IN); On-site; USD 164,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical coverage

Dental coverage

Vision coverage

Flexible spending accounts

Life insurance

Well-being programs

Job summary

Lilly in Indianapolis seeks a Senior Director of Toxicology to provide scientific and administrative leadership, allocating resources, budgeting, and aligning priorities across the division to advance world-class medicines. The role emphasizes leading toxicology research, regulatory submissions, and staff development in a fast-paced environment.

The position includes supervising staff, reviewing regulatory submissions, guiding study designs, and building external partnerships with a focus on

Qualifications

• Leadership and strategic oversight of toxicology programs.
• Strong regulatory experience with nonclinical safety submissions.
• Familiarity with ICH guidance and regulatory standards.

Responsibilities

• Provide strategy planning and oversight of toxicology research and portfolio support activities of the division
• Review and approve Regulatory submissions
• Supervise research and professional staff. Develop performance plans and objectives for staff, conduct performance reviews, and provide mentoring and coaching to staff to facilitate their professional development.
• Serve on toxicology leadership and scientific review committees, providing strategic oversight and approval of toxicology study designs and results
• Engage in external partnerships and manage business relationships and vendors
• Perform responsibilities delegated by senior management

Skills

Leadership

Strategic planning

Regulatory knowledge

ICH guidance familiarity

DABT preferred

Communication

Education

PhD in Toxicology

DVM with MS in Toxicology, public health or related science

Job description

Lilly in Indianapolis seeks a Senior Director of Toxicology to provide scientific and administrative leadership, allocating resources, budgeting, and aligning priorities across the division to advance world-class medicines. The role emphasizes leading toxicology research, regulatory submissions, and staff development in a fast-paced environment.

The position includes supervising staff, reviewing regulatory submissions, guiding study designs, and building external partnerships with a focus on