Director Clinical Development

This role will contribute to advancing both the oncology programs in various stages of development and the fabric of Immunocore’s clinical sciences. The successful candidate will lead and facilitate Clinical Development strategic planning and be accountable for the design and medical oversight of clinical studies, including protocol development, medical monitoring, medical data review, results interpretation, reporting and regulatory submissions. In addition, they will lead innovation in trial design, including development of biomarker strategies. This role will be a key in-house oncology disease area expert for R&D and requires leadership, advising, and close collaboration with members of cross-functional teams. The position will interact with all levels of management, peers and leaders from academic centers involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities. This position can be located at any of our US & UK office locations (Gaithersburg MD, Radnor PA, Abingdon UK). Key Responsibilities: Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Non-clinical and Discovery Research for assigned studies Assure clinical development plans are comprehensive, include key decision points, timely readouts, and risk mitigation for both near and long-term goals Design high quality & innovative clinical trial protocols (including all supporting documents such as Investigator’s Brochure, informed consent, etc.) for lead Oncology target programs that are aligned with the Clinical Development Plan and overall product strategy Establish and maintain strong relationships with key opinion leaders and partners, to facilitate and support external collaborations Provide medical oversight of clinical studies, implementation, medical/safety monitoring, medical data review, results interpretation, and reporting for assigned studies Provide strategic clinical leadership to development teams, including generation of integrated product development plans that incorporate scientific rationale, regulatory input, and advice from medical, patient advocacy groups and payors appropriate for assigned studies Help build and manage the relationships with relevant CROs, facilitate thorough understanding of clinical studies, assist in patient recruitment, and help assure trials are executed on time and within budget Contribute to the regulatory strategy, preparation, and review of regulatory submissions, response to IRB/EC questions, and participate in global health agency meetings Contribute to the development of publication plans, present clinical data at key meetings and publish in high-impact journals Contribute to Business Development activities as requested Supervisory Responsibility (If applicable): No supervisory responsibilities, but may have in the future Education, Experience and Knowledge: Essential Qualifications: MD or MD/PhD with research training and a clinical perspective, coupled with a track record of exceptional achievement in oncology therapy development. Working knowledge of basic and clinical science Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development. Broad understanding of oncology disease area; experience in immuno-oncology highly desirable At least 3 years of relevant experience in clinical drug development across academia or pharmaceutical industry (must include experience conducting early phase trials) 2 years or more experience as a medical monitor in a biotechnology/ pharmaceutical company, and/or CRO. Demonstrated ability to build mutually respectful relationships with colleagues. Trouble shoot challenges and provide direction, guidance, and support to the team to deliver on near term goals Strategic and critical thinker, with proven success in designing innovative clinical trials that have supported successful regulatory filings Established links with the medical community globally and locally, with proven ability to develop close working relationships with opinion leaders Strong communication skills, professional presence, and ability to engage effectively with stakeholders at all levels Collaborative and able to motivate and energize cross functional team members to achieve aggressive goals Strong problem-solving, and analytical skills, able to facilitate discussions among groups with diverse technical expertise, and progress decisions on low to moderate complexity issues Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus Thorough understanding of the drug development process including experience contributing to the development of key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF) and ability to review and interpret clinical data #J-18808-Ljbffr Immunocore