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Description
Location of role Gaithersburg, MD, Conshohocken, PA, Remote, US, Oxford, UK, Remote UK
Department Clinical Development
Key Responsibilities The Executive Director, Early-Stage Clinical Development, Autoimmune will drive assigned autoimmune programs from pre-clinical stages to proof of concept. They will also contribute to the development of infrastructure within Immunocore’s Clinical Sciences department by leading designated projects and workstreams. As the assets develop into the clinic, the incumbent will build a small team.
The successful candidate will spearhead Clinical Development strategic planning and be responsible for the design and medical oversight of assigned clinical studies. This includes protocol development, medical monitoring, medical data review, results interpretation, reporting, and regulatory submissions. Additionally, they will lead innovation in trial design, including the development of biomarker strategies. The incumbent is expected to think strategically at both the program and enterprise levels, with the ability to analyze data, troubleshoot programs, and develop risk mitigation plans
As a key in-house autoimmune disease expert for R&D, this role requires strong strategic leadership, advisory skills, and close collaboration with cross-functional teams whilst providing oversight, guidance, and mentorship to junior physicians working in early-stage clinical trials.
The Executive Director will interact with all levels of management, peers, and leaders from academic centers involved in key collaborations, as well as external stakeholders in the medical and scientific community and global regulatory authorities. The incumbent will work with outstanding people who together pioneer the research, development and commercialization of bi-specific immune modulating therapies.
Key Responsibilities
Apply deep knowledge of the treatment landscape and emerging areas to shape future clinical development strategies and plans for assigned studies and portfolios. Collaborate closely with Project Leaders, Research, Translational, Regulatory, Clinical Operations, Biostatistics, and Clinical Pharmacology colleagues.
Use extensive drug development expertise to design comprehensive clinical development plans, including key decision points, timely readouts, and risk mitigation for both near and long-term goals. Hold clinical matrix team members accountable for achieving clinical objectives.
As the Clinical Development Program Leader, provide strategic clinical leadership to development teams. Generate integrated product development plans that incorporate scientific rationale, regulatory input, competitive landscape, project and portfolio strategy, and advice from patient advocacy groups.
Coordinate and achieve highly complex program objectives through applying advanced expertise, proactively anticipating issues, and developing mitigating solutions. Understand the impact these objectives have on broader corporate strategy.
Design high-quality and innovative clinical trial protocols (including supporting documents such as Investigator’s Brochure and informed consent) for lead autoimmune programs aligned with the Clinical Development Plan and overall product strategy.
Establish and maintain strong relationships with key opinion leaders and partners to facilitate ongoing clinical development, external collaborations, and gather insights into Immunocore programs.
Oversee medical aspects of clinical studies, including implementation, medical/safety monitoring, medical data review, results interpretation, and reporting for assigned studies.
Build and manage relationships with relevant CROs, facilitate a thorough understanding of clinical studies, assist in patient recruitment, and ensure trials are executed on time and within budget.
Partner with Regulatory Affairs to lead regulatory strategy, prepare and review regulatory submissions, respond to IRB/EC questions, and participate in global health agency meetings.
Lead the development of publication plans, present clinical data at key meetings, and publish in high-impact journals.
Mentor and develop team members (e.g., Clinical Study Lead) through training, people management, and leadership development.
Experience and Knowledge
The ideal candidate is an MD or MD/PhD scientist with a clinical perspective, a track record of exceptional achievements in autoimmune therapy development and expertise in multiple disease areas including dermatology and/or type 1 diabetes. They have:
Thorough understanding of the early drug development process including experience contributing to key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF), reviewing and interpreting clinical data.
A strategic and critical mindset with strong problem-solving and analytical skills, as well as a proven ability in designing innovative clinical trials that have supported successful regulatory filings.
Expertise in presenting key headline data with professional authority, anticipating and addressing questions/concerns from senior leadership in a governance setting.
Established links with the medical community globally and locally, with proven ability to develop close working relationships with opinion leaders.
Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA, EMA, and CHMP regulations and guidelines and other international regulatory requirements is a plus.
Solid working knowledge of Microsoft applications such as Excel, Access, Word, and Outlook.
Leadership and Stakeholder Management
Demonstrated ability to build mutually respectful relationships with colleagues, troubleshoot challenges and provide direction, guidance, and support to the team to achieve near-term goals.
Proven team leadership experience, and a view on talent within the industry; ideally having appointed scientists and domain experts into their team.
Ability to facilitate discussions and collaboration among groups with diverse technical expertise, gain alignment and progress decisions on moderate to high complexity issues.
Capable of providing clear direction and holding teams accountable to deliver timely execution of objectives. Motivate and energize cross functional team members to achieve aggressive goals.
Strong oral and written communication skills, professional presence, and demonstrated ability to engage effectively with stakeholders at all levels including senior leaders.
Foundational people management skills with the ability to oversee and manage the activities of junior physicians and clinical scientists, mentor colleagues, and bring the Immunocore vision and strategy to life for others at all levels.
Education And Qualifications
The ideal candidate is an MD or MD/PhD, ideally with relevant 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 and demonstrated experience integrating these disciplines in the context of 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.
