Director, Physician for Infectious Disease - Clinical Development
Location
Abingdon, Oxfordshire | United Kingdom
Job description
Job Details: Director, Physician for Infectious Disease - Clinical Development
Full details of the job.
Vacancy Name
Vacancy Name Director, Physician for Infectious Disease - Clinical Development
Vacancy No
Vacancy No VN353
Employment Type
Employment Type Permanent
Location of role
Location of role Abingdon
About the Company
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.
We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.
Key Responsibilities
Key Responsibilities Now, at this most exciting time in our history, you would be a part of a team that transforms ground-breaking science to benefit patients.
This role will contribute to advancing both the infectious diseases programmes 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 biomarker strategies. This role will be a key in-house infectious diseases 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 centres involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities.
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
• Plan and overall product strategy that meet ethical, scientific, safety, regulatory objectives
•Establish and maintain strong relationships with key opinion leaders and partners, to facilitate and support external collaborations
• Support site selection and site activation activities, including contacting investigators to discuss potential interest in assigned study, developing slides for site initiation visits (SIV), and performing SIVs as needed
• Provide medical oversight of assigned clinical studies including implementation, medical/safety monitoring, protocol compliance and medical data review
• Analyse and interpret data, identifying trends and signals, and synthesizing key learnings to impact subsequent phases of clinical development as well as to shape the translational medicine plans so they are complementary to the clinical development plans
• Work with Pharmacovigilance team to identify and communicate emergent safety signals and trends to the clinical project teams and senior management
• 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 payers 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
• Ensure adherence to pertinent regulatory requirements (e.g., GCP) and to departmental policies, practices and procedures.
• Review and provide input on the design of CRFs from a clinical perspective; participate in user acceptance testing to ensure the appropriate support of data collection
• Contribute to the regulatory strategy, preparation, and review of regulatory submissions, response to IRB/EC questions, and participate in global health agency meetings
• Work to support establishing best practices for the Clinical Department, including the development of standard operating procedures and company processes, while ensuring the highest ethical standards in the conduct of clinical trials are employed
• Contribute to the development of publication plans, draft content and present clinical data at key meetings and publish in high-impact journals
• Contribute to Business Development activities as requested
EXPERIENCE & KNOWLEDGE
• The ideal candidate is an MD or MD/PhD physician scientist with a clinical perspective, coupled with a track record of exceptional achievement in Infectious Diseases therapy development.
• Strategic and critical thinker, with proven success in designing innovative clinical trials that have supported successful regulatory filings
• Track record of leading clinical teams and building mutually respectful relationships with colleagues; has the capability to listen to and integrate input from cross-functional teams and then make clear decisions
• Able to trouble shoot challenges and provide direction, guidance, and support to the team to deliver on near term goals
• Must demonstrate clear understanding of how to safeguard patient safety during the conduct of clinical studies through extensive knowledge of clinical medicine and disease processes; ability to review and provide input into SAE reports
• Established links with the medical community globally and locally, with proven ability to develop close working relationships with opinion leaders and clinical trial sites
• 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
• Excellent written and oral communication skills, with experience in delivering effective presentations on both technical and non-technical subjects.
EDUCATION & QUALIFICATIONS
• MD or MD/PhD with research training
• 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 infectious diseases area; experience in immunology / immunotherapy 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)
• At least 2 years of experience as a medical monitor in a biotechnology/ pharmaceutical company, and/or CRO. #J-18808-Ljbffr
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