Associate Director - External Data Acquisition Lead (EDAL)

Legend Biotech USA; New Jersey; Hybrid; USD 157,360 - 236,040; Full time

Benefits offered by this job

401(k) Plan: 100% match on the first 6% of contributions

Health Benefits: Medical, dental, and vision insurance

Commuter benefits

Tuition reimbursement

Job summary

Legend Biotech USA is looking for an Associate Director, External Data Acquisition Lead, to oversee external data management and integration processes for clinical trials. This role requires extensive experience in clinical data management and vendor oversight, with a focus on Oncology.

The successful candidate will be responsible for mentoring team members, ensuring compliance with data management standards, and collaborating with cross-functional teams. Competitive salary and benefits are offered, reflecting the experience level and contribution of the individual.

Qualifications

• 10+ years of experience in external or clinical data management, with strong third-party vendor oversight.
• Experience designing and governing Data Transfer Specifications (DTS).
• Proven performance in previous roles.

Responsibilities

• Lead external data acquisition ensuring high-quality data aligned with trial objectives.
• Advise on external data collection design and integration feasibility.
• Mentor junior External Data Acquisition Leads.

Skills

clinical data management

third-party vendor oversight

data acquisition

Oncology trials

CDISC standards

Education

Bachelor's or Master's degree in a relevant technical area

Tools

data management software

Job description

The Role

The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager with expertise in the data collection of 3rd party data from various external providers (e.g. laboratories, eCOA providers, technology providers, etc.). The EDAL provides a leadership role in the oversight of the external clinical data integration processes as well as oversight of data quality from various external providers performing testing or data collection services on behalf of Genmab. The EDAL serves as the subject matter expert for all external data management activities performed for clinical trial teams. This role provides strategic data management expertise and is accountable for all end‑to‑end Data Management activities and deliverables pertaining to external data.

The employee will provide oversight of external vendors and the data and/or data services they provide to Genmab. The External Data Lead will support the development and optimization of processes and tools to enable success of the Clinical Operations department. The employee will represent Data Management in Operational Committee’s/fora with the partners and/or DM/stat vendors. The employee will support/train colleagues in and advise on handling of external data management related processes/issues and may act as a mentor. Moreover, the employee shall support the overall strategy and development of Data Management by attending/leading task force initiatives within the department and/or as part of cross‑departmental teams.

Responsibilities

• Lead external data acquisition across one or more studies/programs, ensuring high‑quality, timely, analysis‑ready data aligned with trial objectives.
• Influence protocol and amendment development by advising on external data collection design, integration feasibility, and alignment with CDASH/SDTM and EDC requirements.
• Lead planning and oversight of external data flow strategies and DTS across diverse data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.) to ensure compliant integration.
• Partner with cross‑functional stakeholders to ensure external data acquisition supports operational and scientific goals.
• Develop and manage Trial Data Integrity Plans (TDIP) and Data Flow.
• Create and maintain data transfer specifications (DTS) requirements. Ensure data collection requirements are aligned with external vendor capabilities and vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Ensure vendor data is transferred in standard data formats.
• Provide thorough review of external vendors budget and change order.
• Act as escalation point for complex vendor issues (timeline deviations, integration challenges, misalignment to trial needs).
• Mentor and guide junior External Data Acquisition Leads, providing direction on best practices, issue resolution, and development.
• Lead cross‑functional initiatives including SOP development, process improvement, tools optimization, and external data standards governance.
• Partner with procurement/legal/vendor managers to review technical language in contracts and work orders, ensuring alignment with Genmab standards and systems.
• Promote portfolio‑level consistency and scalability through training, knowledge sharing, and strategic planning support.
• Mentor and develop team members to ensure consistency of External Data Management practices.
• Ensure External Vendor deliverables are performed in compliance with protocol, ICH, GCP and SOPs.

Requirements

• Bachelor's or Master's degree in a relevant technical area; Master's degree preferred.
• 10+ years of experience in external or clinical data management, with strong third‑party vendor oversight and data acquisition experience.
• Experience working on Oncology trials/data.
• Experience designing and governing DTS and complex data flows supporting EDC integration and CDISC standards (CDASH, SDTM).
• Strong knowledge of diverse external data types (e.g., biomarker, central lab, imaging, eCOA/ePRO, genomic) and ability to align acquisition strategies to clinical and analytical objectives.
• Experience managing projects, vendors, and process improvements in global environments.
• Proven performance in earlier role.

Salary (US)

For US based candidates, the proposed salary band for this position is: $157,360.00—$236,040.00. The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long‑term incentives.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional wellbeing support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

About You

• Genuine passion for our purpose
• Precision and excellence in all that you do
• Belief in a rooted‑in‑science approach to problem‑solving
• Generous collaborator who can work in teams with a broad spectrum of backgrounds
• Pride in enabling the best work of others on the team
• Innovative and capable of grappling with the unknown
• Experience working in a fast‑growing, dynamic company (or a strong desire to)
• Hardworking and not afraid to have a little fun while doing so

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work‑life balance. Our offices are crafted as open, community‑based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.