Medical Director Clinical Development

PE Global is currently recruiting for a Clinical Development Medical Director (Neuroscience Speciality or Immunology) for a 6 month contract role with a leading multinational Pharma client based in London - hybrid.

The Clinical Development Director (CDD) is the clinical/scientific and clinical development expert and provides leadership and support to clinical development deliverables and activities within a defined global clinical development program and/or global clinical trial (e.g. clinical development plan, clinical trial protocol), under the leadership of the GPCH.

Job Responsibilities:

• Supports and if assigned leads delivery of all assigned clinical deliverables in the assigned section of a clinical program.
• Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review and program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
• Provides clinical leadership, scientific and medical strategic input for all clinical deliverables in the assigned or defined program activities as applicable.
• Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities).
• Drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates if applicable.
• Provides medical oversight and leadership of trials and may act as medical monitor.
• Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations.
• Supports GPCH or Sr CDMD in ensuring overall benefit/risk assessment and monitor safety of the molecule for the assigned section on an ongoing basis and may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety.
• May be assigned to provide medical input into IDP/CDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas.
• As a medical expert, supports the GPCH or CDH/TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing).