Director, Data Management and Informatics

Scorpion Therapeutics; Pennsylvania; Hybrid; USD 210,000 - 280,000; Full time

Job summary

Scorpion Therapeutics seeks a senior leader to oversee regulatory data management, informatics, and analytics, driving data strategy across IND through NDA/BLA and post‑approval activities. The role focuses on scalable digital tools to improve data access, automation, and decision support.

The position emphasizes leadership of cross‑functional teams, governance, and continuous improvement within a hybrid work environment with travel expectations.

Qualifications

• Experience in data integrity and regulatory processes.
• Proven leadership and cross‑functional collaboration.
• Experience with regulatory submissions and analytics.

Responsibilities

• Lead cross‑functional teams supporting scientific, regulatory, and quality data systems.
• Drive strategy, governance, and process improvements aligned with digital transformation goals.
• Ensure submission‑ready data from IND through NDA/BLA and post‑approval activities.

Skills

Data management

Regulatory CMC

Leadership

Stakeholder engagement

Analytics / AI

Education

Bachelor’s in Chemistry, Pharma, Biology, Data Science or related

Master’s or PhD with 10+ years experience

Tools

Enterprise system lifecycle management

Job description

Role: Senior leader overseeing regulatory data management, informatics, and analytics functions critical to product lifecycle management in a biopharma setting.

Objectives include delivering compliant, submission-ready data from IND through NDA/BLA, and post-approval activities, while developing scalable digital tools that enhance data accessibility, automation, and decision-making.

Responsibilities

Responsibilities encompass leading cross-functional teams supporting scientific, regulatory, and quality data systems, driving strategy, governance, and process improvements aligned with digital transformation goals.

Qualifications

Qualifications: Bachelor's in Chemistry, Pharma, Biology, Data Science, or related with 15+ years (or Master's/Ph.D. with 10+ or 7+ years) of experience in data management, informatics, or regulatory CMC in regulated environments. Proven leadership, stakeholder engagement, and expertise in data integrity, regulatory processes, and enterprise system lifecycle management are required.

Preferred skills

Preferred skills include experience with regulatory submissions, application of analytics or AI/GenAI, and managing diverse scientific teams.

High-value biopharma specifics

High-value biopharma specifics: focus on regulatory data systems supporting IND through NDA/BLA stages, emphasizing compliance, inspection readiness, digital innovation, and enterprise data strategy.

Collaboration spans

Collaboration spans Analytical Development, Regulatory CMC, Quality, Digital, R&D, and Manufacturing divisions.

Work setup

Work setup is hybrid with approximately 10% travel.