Location of role
US or UK
Department
Regulatory Affairs
Key Responsibilities
The Director Safety Physician, Global Patient Safety, is a physician with a robust medical and scientific expertise in clinical medicine, clinical safety evaluation, and pharmacovigilance. The role-holder leads proactive and timely benefit-risk assessments, drives advanced signal detection and analyses from diverse data sources (clinical trials, post-marketing surveillance, real-world data), and shapes the evolving safety profiles of Immunocore's innovative development and marketed products. The Director Safety Physician is responsible for the successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. This Director Safety Physician provides guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and post-marketing surveillance. This role provides a unique opportunity to collaborate closely with cross-functional colleagues such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Key Responsibilities
* Drive the strategic vision and execution of safety surveillance and benefit–risk assessment across the life cycle of assigned products, including the development and refinement of project-level safety evaluation and reporting strategies.
* Ensure alignment with clinical and regulatory objectives, gain cross-functional agreement, and adapt strategies based on evolving insights from single cases and aggregate data.
* Anticipate and shape emerging safety issues by creating strategic benefit–risk frameworks that inform labelling, clinical trial design, and post-marketing commitments.
* Ensure consistency in approaches to emerging safety findings from clinical studies, gain cross-functional alignment, oversee implementation, and adapt strategies based on evolving insights from individual cases and aggregate data.
* Provide medical and scientific leadership in signal detection, analysis, and input into governance forums, setting cross-functional safety strategy and providing recommendations that impact corporate decision-making.
* Provide cross-functional leadership to ensure consistency in safety data collection and reporting for the assigned products.
* Provide medical review of case safety reports (ICSRs), including causality, seriousness, expectedness, and clinical relevance, ensuring medical accuracy and regulatory compliance.
* Ensure accuracy and timeliness of expedited reports and periodic reports from clinical trials and post-marketing surveillance.
* Participates in the identification, analysis and reporting of possible trends and concerns with company products including the identification and evaluation of safety signals through assessment of single case safety reports, aggregate trend analyses, and literature review.
* Responsible for signal detection and evaluation, conducting scientific analyses of clinical trial, post-marketing, literature, and epidemiological data to support timely risk identification and mitigation.
* Lead the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
* Accountable for the preparation and maintenance of Reference Safety Information (RSI) and product labelling (e.g., Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP).
* Accountable for medical and scientific input into responses to regulatory authority queries regarding product safety and risk management.
* Guide internal collaborators and external vendors in best practices for safety data collection, coding, analyses and evaluation, ensuring high-quality standards.
* Oversee the preparation and review of safety sections of regulatory submissions, including DSURs, PBRERs, Risk Management Plans (RMPs), Investigator Brochures, and labelling updates.
* Accountable for the medical and scientific accuracy and quality of aggregate safety reports (DSUR, PBRER), risk management plan(s), and safety sections of health authority queries, protocols, and investigator brochures
* Author medical-safety sections of submission documents (Summary of clinical Safety, Clinical Overview).
* Maintain up-to-date knowledge of Immunocore therapeutic areas and global regulatory requirements for PV.
* Participate in development of internal PV business infrastructure including standard operating procedures and work practice instructions to ensure seamless PV processes.
SUPERVISORY RESPONSIBILITY
This position will not have line manager responsibilities, but provides safety leadership to cross functional teams
COMPETENCIES
* Strong medical and clinical judgment in evaluating adverse event data and benefit–risk profiles.
* Strong scientific and analytical skills, with the ability to translate data into meaningful insights.
* Collaborative leadership in cross-functional activities.
* Effectively communicate/present complex scientific and medical concepts to both medical and non-medical audiences.
* Knowledge of global PV regulations and risk management requirements (FDA, EMA, ICH, CIOMS).
Essential
EXPERIENCE & KNOWLEDGE
* Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.
* Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
* Knowledge of clinical development process
* Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
Desirable
* Advanced degree in epidemiology, pharmacology, or biomedical sciences (PhD/MPH)
* Knowledge of drug approval process in major countries
* Experience with different commercially available safety databases.
* Board certification in a relevant specialty
* Experience in regulatory submissions and interactions regarding drug safety
Education & Qualifications
* M.D./D.O. degree with at least three years of pharmacovigilance experience, and at least two years of clinical experience or relevant experience to understand clinical drug development
* At least three years of practical clinical experience post licensure
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 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.