Clinical Development Medical Director, Hepatology and Transplant
Inseriert am: 19.03.2020
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Job ID283237BRPosition TitleClinical Development Medical Director, Hepatology and TransplantApply to Job
Job Description
2 specialty areas, hepatology and transplant! we aim to transform patient care with life-changing, innovative therapies that provide patients with a longer & healthier life for transplant and non-viral liver disease patients.
As our Medical Director (MD) you will be responsible for the global scientific and medical strategy of assigned sections of a complex clinical development program (e.g., an indication, new formulation, or specific development phase) and may lead indications or programs, depending on the size, nature and complexity. You will be responsible for design and execution of a Clinical Development Plan (CDP) and medical monitoring and reporting of one or more clinical trials to support decision milestones, regulatory approval/market access, and budget targets for assigned section or sections. You will also may lead the Global Clinical Team (GCT), work closely Clinical Trial Teams (CTTs), represent Clinical Development at the Global Program Team (GPT), and together with Drug Safety and Epidemiology (DS&E) own, the risk benefit assessment of the indications or programs.
Your responsibilities will include:
• Provide clinical leadership and medical and scientific strategic input for clinical deliverables in the assigned section of a clinical program or programs. This includes contribution to clinical trial design and responsibility for medical/scientific components of assigned CTP(s) ensuring alignment with the CDP, available disease and program level clinical standards, and the Target Product Profile (TPP)
• For assigned section or program, provide expert medical and scientific input and contribute to writing trial related documents (e.g., CTPs, case report forms, data monitoring committees, data analysis plans, reports, publications) consistent with CDP and aligned to achieve the TPP, and presentation material for trial-related advisory boards, investigators meetings, protocol training meetings for Novartis local medical organizations
• Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigators’ Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) and is responsible for delivering high quality clinical/medical input into regulatory documents and registration dossiers for assigned sections
• In collaboration with the relevant CTT members, conduct ongoing medical review of clinical trial data and manage patient safety; report on trial data to safety and clinical boards (e.g., SMT, GCT, GPT); provide input into final analysis and interpretation of results including the development of Clinical Study Reports (CSRs), publications and internal/external presentations; and ensure optimal execution of program Operational Plans including direct medical and operational support of trials as needed
• Support GPH or GPMD in ensuring overall safety of the molecule in collaboration with the Brand Safety Leader for the assigned section, may be a core member of the Safety Management Team (SMT), and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents)
• May lead GCT, work closely with CTTs and may represent Clinical at GPT
• Support the Franchise Therapeutic Area Head (TAH) by providing medical input into CDP and CTP reviews and contributing/driving development of disease/program clinical standards for programs and new disease areas
Minimum requirements
What you’ll bring to the role:
• MD or equivalent medical degree required. Advanced knowledge in medical/scientific area (e.g., internal medicine or sub-specialty training) required
• ≥ 3 years clinical trial experience with demonstrated ability to manage several trials in parallel with multidisciplinary trial teams
• Advanced knowledge of assigned therapeutic area is desired, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
• Demonstrated knowledge and application of statistical analysis methodology; can identify trends and interpret/report results effectively
• Demonstrated ability to establish strong scientific partnership with key partners
• Thorough knowledge of GCP, clinical trial design, statistics, and regulatory/clinical development process
WHY CONSIDER NOVARTIS?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.DivisionGlobal Drug DevelopmentBusiness UnitCD&A GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
