Senior Director, Clinical Data Management
Our leaders in R&D are internationally recognised 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.
The Senior Director, Clinical Data Management (CDM) is a strategic leadership role responsible for overseeing all aspects of clinical data management across all Immunocore clinical trials. Reporting to the VP Global Clinical Operations, this role will drive the data management strategy, oversee a team of data management and technical personnels, and ensure the effective execution of clinical study strategy and data processes.The ideal candidate will be capable of challenging and improving current processes and embracing new methods and working styles, through empowerment utilizing the full potential of the employees and 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.
Key Responsibilities:
Develop and execute the clinical data management strategy (CDM) to support the company's clinical pipeline.
Develop and lead a highly functional and scalable data management organization, including strategy, operations, infrastructure, and processes.
Accountable for the timely delivery, integrity, and quality of all clinical data.
Provide oversight to contract research organizations (CROs) and vendors, as point of escalation, to ensure timely delivery and compliance with regulations regarding outsourced activities.
Act as the primary interface between the data management function and other key stakeholders, including Clinical, Biostatistics and Programming, and Clinical Operations.
Work with cross-functional teams to define data strategies, identify risks, and develop mitigation plans.
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.
Lead the development and implementation of CDM SOPs, work instructions, standards, and best practices.
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.
Foster a collaborative, solutions-oriented culture that encourages innovation and continuous improvement.
Facilitate the development of key data and metrics reports for data cleaning and review.
Manage the CDM budget, ensuring cost-effective solutions and resource allocation.
Stay updated with the latest advancements in data management technologies and methodologies and implement them as appropriate.
Other duties as needed.
Supervisory Responsibility (If applicable):
Provide leadership, direction, and expertise to data management staff; foster and promote the long-term development of the clinical data management team; drive a culture of collaboration and continued improvement; and work closely with other functional leads to maintain cross-functional operational excellence.
Oversee hiring, mentoring, and professional development to build and sustain a high-performing team.
Establish and communicate clear goals, expectations, and performance metrics for the team.
Education, Experience and Knowledge:
Bachelors or Masters in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields (Ph.D. preferred).
15+ years of experience in CDM within the pharmaceutical/biotechnology industry or CRO.
5+ years of direct line leadership with proven ability of successfully building a CDM team and overseeing multiple clinical trials.
Demonstrated leadership in providing strategic direction to team/project and effectively manage through unexpected events and competing priorities.
Extensive experience in clinical data management systems, including EDC, and other advanced data technologies.