Overview

LOCATION: Dublin or London
ROLE TYPE: Hybrid Working

Major Activities

• Provides clinical leadership, scientific and medical strategic input for all clinical deliverables in the assigned or defined program activities as applicable. Clinical deliverables may include (sections of) individual protocols consistent with the Integrated Development Plans (IDP) and CDP, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• 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 overall benefit/risk assessment and monitors safety of the molecule for the assigned section and may be a core member of the Safety Management Team (SMT); supports program safety reporting (e.g., PSURs, DSURs) in collaboration with Patient Safety
• May be assigned to provide medical input into IDP/CDP and CTP reviews and contribute to developing disease clinical standards for new disease areas
• As a medical expert, supports interactions with external and internal stakeholders (regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups; internal stakeholders such as CTT, Translational Medicine, Global Medical Affairs, Marketing, HE&OR) and may lead or co-chair steering committees for defined clinical trials or sections of a development program
• May work with Biomedical Research/Translational Medical Sciences to drive transition of pre-PoC projects to Development Decision Point and with Business Development & Licensing, including target identification and due diligences
• Ensures career development of program reports and other clinical colleagues through performance management and talent planning; provides onboarding, training, and mentoring support
• Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule; may serve as a speaker for franchise medical/scientific training
• May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development initiatives)
• May be assigned to lead clinical trials as Clinical Scientific Lead and provide leadership for all clinical aspects of a clinical trial

Key Performance Indicators

• Timely delivery of high quality IDP/CDP sections, CTPs, and other clinical deliverables aligned with IDP/CDP and TPP; endorsed by review committees and internal/external stakeholders
• Applies robust clinical research methodology across disease areas and development phases
• High-quality medical and scientific review of trial data; timely development of quality disease/program clinical standards, publications, and other CD deliverables
• Quality contributions to clinical sections of regulatory documents and submission dossiers
• Effective management of clinical teams; ability to deputize for GPCH/Sr CDMD as needed
• Demonstrates Novartis values and behaviors

Education

• MD or equivalent medical degree required. Medical Board certification preferred; advanced knowledge in a medical/scientific area (e.g., internal medicine or sub-specialty)
• Clinical practice experience ≥ 4 years (including residency) preferred

Experience

• ≥ 5 years of involvement in clinical research or global drug development in academic or industry settings (Phases I–IV); ≥ 3 years in conducting clinical trials in a global/matrix environment; late-phase experience preferred
• Strong scientific acumen to analyze and interpret literature and data
• Advanced knowledge of the assigned therapeutic area
• Proven ability to establish scientific partnerships with stakeholders
• Thorough knowledge of ICH, GCP, trial design and methodology, statistical analysis, and regulatory/clinical development processes
• People management experience, including global matrix environments
• Excellent communication and interpersonal skills; strong negotiation and conflict resolution abilities