Overview
Executive Director, Early-Stage Clinical Development, Autoimmune role at Immunocore. Location options include Gaithersburg, MD; Conshohocken, PA; Remote, US; Oxford, UK; Remote UK.
Key Responsibilities
* Drive assigned autoimmune programs from pre-clinical stages to proof of concept; contribute to the development of Immunocore’s Clinical Sciences infrastructure; lead designated projects and workstreams; build a small team as assets develop into the clinic.
* Spearhead Clinical Development strategic planning; design and medical oversight of assigned clinical studies, including protocol development, medical monitoring, medical data review, results interpretation, regulatory submissions; lead innovation in trial design and biomarker strategies.
* Think strategically at program and enterprise levels; analyze data; troubleshoot programs; develop risk mitigation plans.
* As a key in-house autoimmune disease expert, provide strategic leadership, advisory support, and cross-functional collaboration; mentor junior physicians involved in early-stage clinical trials.
* Interact with management, peers, and leaders from academic centers and external stakeholders, including global regulatory authorities; collaborate to advance autoimmune program research and development of bi-specific immune-modulating therapies.
Experience and Knowledge
* An MD or MD/PhD with a clinical perspective and a track record in autoimmune therapy development; expertise in multiple disease areas including dermatology and/or type 1 diabetes.
* Thorough understanding of early drug development; experience contributing to key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF); ability to review and interpret clinical data.
* Strategic and analytical mindset with strong problem-solving skills; proven ability to design innovative clinical trials that have supported regulatory filings.
* Experience presenting key data with professional authority; ability to address questions from senior leadership in governance settings.
* Established links with the medical community globally and locally; ability to develop relationships with opinion leaders.
* Working knowledge of GCP, ICH, GDP and relevant CFRs; familiarity with MHRA, EMA, CHMP guidelines;
* Proficiency with Microsoft Excel, Word, Outlook (and related MS Office tools).
Leadership and Stakeholder Management
* Demonstrated ability to build mutually respectful relationships, troubleshoot challenges, and provide direction, guidance, and support to teams to achieve goals.
* Proven people leadership experience and an eye for talent; experience appointing scientists and domain experts into teams.
* Ability to facilitate collaboration among groups with diverse technical expertise; gain alignment and progress decisions on complex issues.
* Provide clear direction and hold teams accountable for timely execution; motivate cross-functional teams to achieve aggressive goals.
* Strong oral and written communication skills, professional presence, and ability to engage with stakeholders at all levels, including senior leaders.
* Foundational people management skills to oversee and mentor junior physicians and clinical scientists; align the team with Immunocore’s vision and strategy.
Education and Qualifications
* The ideal candidate is an MD or MD/PhD, ideally with training in treating immune-mediated diseases.
* 5-8 years of relevant experience in clinical drug development, or 2-5 years of relevant clinical development experience with 5-10 years in clinical practice in a related field.
* At least two years of experience as a medical monitor in a biopharmaceutical company and/or CRO.
* Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements; demonstrated ability to integrate these disciplines in drug development.
* A broad understanding of autoimmune disease area; experience in dermatology and/or type 1 diabetes is highly desirable.
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.
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