Director, MLR Operations: Strategic Process & Governance

ITF Therapeutics LLC; United States; On-site; USD 210,000 - 225,000; Full time

Job summary

ITF Therapeutics LLC in the United States seeks a Director, Medical, Legal, & Regulatory (MLR) Operations to own strategy, governance, and end-to-end operation of the MLR review process across promotional, medical, training, and other materials.

The role requires 10 years in pharma/biotech with MLR/PRC operations exposure, platform ownership (Veeva Vault PromoMats), and strong leadership to balance speed, quality, and compliance while guiding senior leaders.

Qualifications

• Experience shaping an MLR review process at scale.
• Strong understanding of FDA promotional regulations and PhRMA Code.
• Proven ability to manage senior leaders without direct authority.

Responsibilities

• Own end-to-end MLR operating model including intake, routing, review cycles, approvals and archiving.
• Set governance standards and ensure adoption across functions.
• Lead cross-functional process improvement using data analytics.
• Forecast submission volume and reviewer capacity for launches.

Skills

MLR operations leadership

Stakeholder management

Data-driven decision making

Regulatory science knowledge

Education

Bachelor's degree

MBA/MPH or advanced degree

Tools

Veeva Vault PromoMats

Job description

ITF Therapeutics LLC in the United States seeks a Director, Medical, Legal, & Regulatory (MLR) Operations to own strategy, governance, and end-to-end operation of the MLR review process across promotional, medical, training, and other materials.

The role requires 10 years in pharma/biotech with MLR/PRC operations exposure, platform ownership (Veeva Vault PromoMats), and strong leadership to balance speed, quality, and compliance while guiding senior leaders.