Clinical Development Medical Director - Renal
Jobbeschreibung
Basel, Basel-Stadt, Schweiz
Novartis
27.04.2024
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About the roleThe Clinical Development Medical Director (CDMD) is
responsible for leading the strategic planning and management of the
assigned clinical program(s) from an end-to-end clinical development
perspective. As CDMD in Renal development, you will have oversight of
the clinical development for the assigned programs and drive execution
of the clinical development plan. In addition, you will enable an
empowered organization, which can navigate in a matrix environment and
adjust quickly to business needs. Your responsibilities:• Providing
clinical leadership and strategic medical input for all clinical
results in the assigned project or section of a clinical program•
Leading development of clinical sections of trial and program level
regulatory documents• Driving execution the assigned clinical program
and/or clinical trial in partnership with global line functions,
assigned Global Trial Directors (GTDs), and regional/country medical
associates, where applicable• Supporting (Senior) Global Program
Clinical Head (GPCH) in ensuring overall safety of the molecule for
the assigned section, and may act as a core member of the Safety
Management Team (SMT), supporting overall program safety reporting in
collaboration with Patient Safety colleagues• Supporting the Clinical
Development Head (CDH) by providing medical input into Clinical
Development Plan (CDP), Integrated Development Plan (IDP) and Clinical
Trial Protocol (CTP) reviews, and contributing to/driving development
of disease clinical standards for new disease areasCommitment to
Diversity & Inclusion:We are committed to building an outstanding,
inclusive work environment and diverse teams representative of the
patients and communities we serve.Role RequirementsWhat you bring to
the role: • MD/medical degree is required in addition to sophisticated
knowledge and clinical training in medical/scientific area; Clinical
practice experience 4 years (including residency) and board
certification or eligibility in Renal disease area preferred• Minimum
of 7 years of proven experience in clinical research or drug
development• Experience in an academic clinical research or industry
environment spanning clinical activities in Phases I through IV
required.• 2 years of contribution to and accomplishment in all
aspects of conducting clinical trials (e.g., planning, driving,
reporting and publishing) in a global/matrix environment in
pharmaceutical industry required.• Solid understanding of Renal
disease area is required, with validated ability to interpret, discuss
and present efficacy and safety data relating to clinical trial(s) and
proven ability to understand and interpret basic and clinical
scientific research reports• Demonstrated ability to establish
effective scientific partnerships with key collaborators• Solid
understanding of GCP, clinical trial design, statistics, and
regulatory and clinical development processes• Previous global people
management experience is preferred, though this may include management
in a matrix environment.Final job title and associated
responsibilities will be commensurate with the successful candidates’
level of expertise (Senior/Director/Associate)****Some restrictions to
flexible working models may apply and will be discussed at interview
if applicable Why Novartis? Our purpose is to reimagine medicine to
improve and extend people’s lives and our vision is to become the most
valued and trusted medicines company in the world. How can we achieve
this? With our people. It is our associates that drive us each day to
reach our ambitions. Be a part of this mission and join us! Learn more
here: receive: You can find everything you need to know about our
benefits and rewards in the Novartis Life Handbook. to Diversity and
Inclusion: Novartis is committed to building an outstanding, inclusive
work environment and diverse teams' representative of the patients and
communities we serve.Join our Novartis Network: If this role is not
suitable to your experience or career goals but you wish to stay
connected to hear more about Novartis and our career opportunities,
join the Novartis Network here: Business UnitCLINICAL DEVELOPMENT DEV
Work LocationBasel Company/Legal EntityNovartis Pharma AGFunctional
AreaResearch & Development Job TypeFull TimeEmployment TypeRegular
Shift WorkNoEarly TalentNoCountry: Switzerland