Senior Director (Head), Clinical Data Management

The Lotus Group LLC; United States; On-site; USD 180,000 - 280,000; Full time

Job summary

The Lotus Group LLC, a clinical stage biopharmaceutical company, is seeking a Senior Leader to oversee the clinical data management function. You will build and lead a team responsible for data standards, database design, data cleaning, and data delivery across the active pipeline, reporting directly to a senior R&D leader.

You will work cross-functionally with biostatistics, clinical operations, and regulatory affairs to ensure submission-ready data packages and drive data integrity through

Qualifications

• Led data management through at least one regulatory submission.
• Experience running data management on large-scale studies.
• Chronic disease experience preferred; neuroscience or immunology experience considered.
• Ability to work autonomously and own outcomes.

Responsibilities

• Lead data management strategy across multiple concurrent studies.
• Oversee database build, edit checks, data cleaning, and query resolution to ensure data integrity from first patient in through database lock.
• Manage vendor and CRO relationships for data management deliverables.
• Lead data management input into regulatory submissions and work directly with cross functional teams to ensure submission ready data packages.
• Build and manage a team, setting standards for the function as the company scales.
• Represent data management in cross functional governance meetings and communicate data status and risk to senior leadership.

Skills

Data management leadership

Regulatory submissions

Cross-functional collaboration

Team building

Job description

A clinical stage biopharmaceutical company advancing a pipeline in chronic disease. The company is well funded and building out its clinical data management function to support late stage development and upcoming regulatory submissions.

The Role

• Senior leadership role overseeing the clinical data management function
• Build and lead the team responsible for data standards, database design, data cleaning, and data delivery across the active pipeline
• Report directly to a senior R&D leader
• Work cross functionally with biostatistics, clinical operations, and regulatory affairs

What You Will Do

• Lead clinical data management strategy across multiple concurrent studies
• Oversee database build, edit checks, data cleaning, and query resolution to ensure data integrity from first patient in through database lock
• Manage vendor and CRO relationships for data management deliverables
• Lead data management input into regulatory submissions and work directly with cross functional teams to ensure submission ready data packages
• Build and manage a team, setting standards for how the function operates as the company scales
• Represent data management in cross functional governance meetings and communicate data status and risk directly to senior leadership

What You Need

• Led data management through at least one regulatory submission. Required, not preferred
• Run data management on a large scale study, meaning a study of significant size and complexity, not a small proof of concept trial
• Chronic disease experience strongly preferred; neuroscience or immunology experience also considered given overlap in study complexity and regulatory requirements
• Comfortable operating with autonomy and taking ownership of outcomes rather than waiting for direction

What This Role Offers

• Build a function from a position of real influence, not inherit someone else's structure
• Work on a pipeline with active regulatory milestones ahead
• Compensation competitive and commensurate with a senior leadership hire at this level, including base, bonus, and equity