Senior Director, Data Management

DBV Technologies; Bernards Township (NJ); Sur place; USD 200 000 - 280 000; Plein temps

Résumé du poste

DBV Technologies seeks a Senior Director, Data Management to lead clinical data management and move core data collection and standards work in-house while upholding data quality and regulatory compliance.

You will oversee EDC build and SDTM configuration, work with Clinical, Biostatistics, Safety, and Regulatory teams, and direct CRO partners. The role requires deep hands-on data management experience and broad ownership as the function evolves.

Qualifications

• Mastery of global Data Management processes.
• Strong experience with Electronic Data Capture (EDC) systems, particularly Medidata Rave.
• Experience with ePRO solutions.
• Advanced knowledge of CDISC SDTM and ADaM data standards.
• Proficiency in SAS; experience with JMP, JMP Live, R, Python, or other data science tools is highly desirable.

Responsabilités

• Provide senior oversight of data management processes from CRF development to SDTM programming.
• Standardize study monitoring reports and data management metrics directly from EDC.
• Support integration and management of pharmacovigilance data streams for signal detection, regulatory, and analytical needs.
• Global CRO oversight of data management activities and delegation of tasks to internal team.
• Management of database lifecycle activities, including freeze, lock, and archiving and support team as backup for existing studies and support and development of data pipelines for prospective studies.

Connaissances

Data leadership

Clinical data management

Regulatory knowledge

Formation

Master's degree in bio/pharma/related field

Outils

Medidata Rave

SAS

JMP

R

Python

Description du poste

Description

The Senior Director, Data Management will lead clinical data management at DBV Technologies, a biopharmaceutical company developing treatments for food allergy. The role is responsible for moving core data collection and standards work, including EDC build and SDTM configuration, from external vendors to an internal team, while keeping data quality and regulatory requirements intact. You will work with Clinical, Biostatistics, Safety, and Regulatory colleagues, direct the data management work of our CRO partners, and build out the internal team. The position suits someone with deep hands-on data management experience who wants broad ownership of a function that is still taking shape.

Location

Warren, New Jersey - minimum 3 days on site

Salary Range

$200-280k

Key Responsibilities

• Provide senior oversight of data management processes from CRF development to SDTM programming.
• Standardize study monitoring reports and data management metrics directly from EDC
• Support integration and management of pharmacovigilance data streams for signal detection, regulatory, and analytical needs.
• Global CRO oversight of data management activities and delegation of tasks to internal team.
• Management of database lifecycle activities, including freeze, lock, and archiving and support team as backup for existing studies and support and development of data pipelines for prospective studies.

Qualifications

• Mastery of global Data Management processes.
• Strong experience with Electronic Data Capture (EDC) systems, particularly Medidata Rave.
• Experience with ePRO (electronic Patient Reported Outcomes) solutions
• Advanced knowledge of CDISC SDTM and ADaM data standards.
• Proficiency in SAS programming language; experience with JMP, JMP Live, R, Python, or other data science tools is highly desirable.
• Behavioral skills :
• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.

DBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians who believed that food allergies could one day be treated safely and effectively.

We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin, to develop treatment options for immunologic diseases with significant unmet medical need.

This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin.

Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy.

Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.