Director of Clinical Data Management, Early Development Lead

Director of Clinical Data Management, Early Development Lead

Company Name: Immunocore

Location of Role

US- Gaithersburg, MD or Conshohocken, PA

Department

Biometrics

Key Responsibilities

The Director, Clinical Data Management (CDM) is a strategic leadership role responsible for overseeing all aspects of clinical data management across all Immunocore clinical trials within an asset or indication. Reporting to the Head of Data Management, this role will drive the data management strategy of studies within their remit, oversee a team of data management personnel, and ensure the effective execution of clinical study strategy and data processes. The ideal candidate will be capable of challenging and improving current processes, have the ability to translate the science from protocol design into data points, and embrace new methods and working styles through empowerment by utilizing the full potential of the employees. They will have a deep understanding of clinical data management, systems, including EDC, and other advanced data technologies, and will play a pivotal role in implementing innovative solutions to streamline data management operations and deliver high-quality data for regulatory submissions.

• Lead, manage, and perform “hands-on-task" within the Early Development Clinical Data Management (CDM) space, ensuring operational excellence and consistency in clinical trial execution.
• Develop and implement data management strategies to ensure high-quality data collection, processing, and analysis.
• Oversee the design, development, and maintenance of clinical databases, ensuring compliance with regulatory requirements and industry standards.
• Collaborate with cross-functional teams, including Clinical Operations, Clinical Development, Biostatistics, and Regulatory Affairs, to ensure seamless data flow and integration.
• Provide leadership and mentorship to the CDM team, fostering a culture of continuous improvement and professional development.
• Ensure engagement and alignment of Immunocore’s strategy and priorities with Functional Service Providers (FSPs).
• Support acceleration of clinical programs and other continuous improvement efforts, applying innovative thinking to shape future strategy.
• Monitor and report on key performance indicators (KPIs) related to data management activities, ensuring timely and accurate delivery of clinical trial data.
• Manage relationships with external vendors and partners, ensuring high-quality deliverables and adherence to timelines.
• Represent data management in leadership meetings and cross-departmental strategic discussions.
• Improve the process of clinical database specifications, including eCRF design, user requirements, edit checks, query logic, and data validations; oversee the EDC system build, testing, and database release.
• Provide oversight for the development and quality control of data management documents including data management plans (DMPs), data validation specifications, and data transfer agreements (DTAs), etc.
• Ensure compliance with SOPs, GCP, ICH guidelines, and other established guidelines of national and international regulatory authorities.
• Work closely with cross-functional team members to address complex data issues.
• This position requires 5% domestic and or international travel at the discretion of management.
• Other duties as needed.

Supervisory Responsibility

This position will be responsible for managing a team of full-time employees and contractors.

Education, Experience and Knowledge

• Bachelor's degree in Life Sciences, Computer Science, or related field with 16+ years of work experience; advanced degree preferred.
• Minimum of 10 years of experience in clinical data management, with at least 5 years in a leadership role.
• Strong knowledge of global data management standards and practices, particularly within oncology.
• Proven experience in managing and leading data management teams in a fast-paced, high-throughput environment.
• Excellent understanding of clinical trial processes, regulatory requirements, and industry standards (e.g., CDISC, SDTM, ADaM).
• Proficiency in clinical data management systems (e.g., Medidata Rave, Oracle Clinical) and electronic data capture (EDC) tools.
• Strong analytical and problem-solving skills, with the ability to think strategically and drive innovation.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• Demonstrated ability to manage multiple projects and priorities in a dynamic environment.

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases, and autoimmune disease. Our leaders in R&D are internationally recognized as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases, and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.