Senior Director, Clinical Development & Operations

ANI Pharmaceuticals, Inc.; Princeton (NJ); On-site; USD 265,000 - 285,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plans

Paid time off

Job summary

ANI Pharmaceuticals, Inc. seeks a Sr. Director of Clinical Development to provide strategic and operational leadership across all clinical functions, advancing the rare disease portfolio.

The role oversees Clinical Development for scientific quality, regulatory compliance, and trial execution on a global scale. Responsibilities include leading a high-performing team, aligning cross-functional partners, and ensuring studies meet timeline, budget, and quality requirements in collaboration with

Qualifications

• Advanced degree in clinical development or related field.
• Minimum 8 years in Clinical Development with 3+ in leadership.
• Experience leading Clinical Operations in pharma.
• Experience with rare disease, ophthalmology, or inflammation.
• Proven interaction with FDA and regulatory agencies.

Responsibilities

• Develop and execute integrated Clinical Development strategy.
• Lead and mentor Clinical Development team.
• Oversee global interventional and post-marketing studies (Phase 1–4).
• Ensure study design feasibility, data integrity, and timelines.

Skills

Strategic leadership

Cross-functional collaboration

Regulatory understanding

Budget management

Clinical operations oversight

FDA/pharma compliance

Education

MD/DO/PharmD/PhD

Tools

Regulatory compliance tools

Vendor management

Job description

ANI Pharmaceuticals, Inc. seeks a Sr. Director of Clinical Development to provide strategic and operational leadership across all clinical functions, advancing the rare disease portfolio.

The role oversees Clinical Development for scientific quality, regulatory compliance, and trial execution on a global scale. Responsibilities include leading a high-performing team, aligning cross-functional partners, and ensuring studies meet timeline, budget, and quality requirements in collaboration with