Medical Director for Infectious Disease Clinical Development

1 month ago

Abingdon, Oxfordshire, United Kingdom Immunocore Full time
Job Title: Medical Director for Infectious Disease Clinical Development

Immunocore, a pioneering biotechnology company, is seeking a highly skilled Medical Director for Infectious Disease Clinical Development to join our team. As a key member of our Clinical Development department, you will play a critical role in shaping the future of our clinical development strategy and plans.

Key Responsibilities:
  1. 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.
  2. Assure clinical development plans are comprehensive, include key decision points, timely readouts, and risk mitigation for both near and long-term goals.
  3. Plan and overall product strategy that meet ethical, scientific, safety, regulatory objectives.
  4. Provide medical oversight of assigned clinical studies including implementation, medical/safety monitoring, protocol compliance and medical data review.
  5. 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.
  6. Work with Pharmacovigilance team to identify and communicate emergent safety signals and trends to the clinical project teams and senior management.
  7. 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.
  8. 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.
  9. Ensure adherence to pertinent regulatory requirements (e.g., GCP) and to departmental policies, practices and procedures.
  10. Contribute to the regulatory strategy, preparation, and review of regulatory submissions, response to IRB/EC questions, and participate in global health agency meetings.
  11. 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.
  12. Contribute to the development of publication plans, draft content and present clinical data at key meetings and publish in high-impact journals.
  13. Contribute to Business Development activities as requested.
Requirements:
  1. 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.
  2. Strategic and critical thinker, with proven success in designing innovative clinical trials that have supported successful regulatory filings.
  3. Track record of leading clinical teams and building mutually respectful relationships with colleagues.
  4. 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.
  5. Established links with the medical community globally and locally, with proven ability to develop close working relationships with opinion leaders and clinical trial sites.
  6. 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.
Education & Qualifications:
  1. MD or MD/PhD with research training.
  2. Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
  3. At least 3 years of relevant experience in clinical drug development across academia or pharmaceutical industry (must include experience conducting early phase trials).
  4. At least 2 years of experience as a medical monitor in a biotechnology/pharmaceutical company, and/or CRO.

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