Director, Data Management

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role:

Reporting to the Sr. Director, Data Management, the Director, Data Management is responsible for the oversite of Data Management vendors to ensure timelines and deliverables are met and is accountable for all aspects of the clinical trial data management process from study start up through database lock, including escalations of issues when necessary.

 Provide data management expertise and input to process development and improvement activities to ensure quality, compliance, and consistency within Data Management and collaborate across all functions to drive data deliverables and ensure timelines are met.

Manage multiple critical timelines, build effective relationships with vendors and external partners and to work cross-functionally in a productive manner to support the development of our clinical programs all while demonstrating our core values are important aspects of this role.

Responsibilities:

• Support overall development of the Data Management group.
• Participate in the development and maintenance of Data Management Standard Operating Procedures (SOPs) and Work Instructions.
• Participate in process improvement initiatives, as needed.
• Lead studies and function as the Data Management primary point of contact for all study team members and vendor partners.
• Responsible for oversight of CRO DM activities for multiple clinical studies.
• Work with other functions to manage timelines and ensure that clinical data management deadlines are met.
• Oversee external data from third-party vendors such as central laboratories in support of timelines and data-related deliverables.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics, audit reports, and input from project team members and other stakeholders.
• Train other personnel on study-related items and data management principles, as needed.
• Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs, and other documents as required.
• Participate in the development of Data Management standards.

• Manage performance and development of direct reports.

Competencies Include:

• Strong interpersonal and communication skills, with expertise in successfully managing external stakeholder relationships.
• Demonstrated leadership, and organization skills, along with problem solving, conflict resolution, and team building skills.
• Ability to think critically with strong attention to detail.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• 10+ years of experience in Data Management in the CRO/pharmaceutical/biotechnology industry.
• Working knowledge of EDC systems – preferably Medidata RAVE.
• Proficiency in all areas of Data Management activities required.
• Excellent experience working in cross-functional team-oriented environments.
• Strong oncology experience required.
• Understanding of ICH and regulatory environment as it pertains to data management.
• Proven experience in internal and external inspection activities required.
• A working knowledge of SDTM and CDASH principles and other industry guidelines strongly preferred.

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from “@nuvalent.com” email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

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