Medical Director - Dermatology Translational Medicine
Jobbeschreibung
Basel, Basel-Stadt, Schweiz
Novartis
27.04.2024
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About the role350 million! That is the estimated number of patients
worldwide suffering of atopic dermatitis or psoriasis. Join Novartis
to help find the right drugs to transform and improve patient's lives
all around the world. You will provide medical and scientific
leadership and expertise in a role that significantly impacts the
entire Novartis Dermatology drug development pipeline.• Drive success
of early global programs, develop and implement strategies to achieve
clinical Proof of Concept or Proof of Mechanism to enable transition
to further development • Drive success of late global programs when
appropriate by developing and implementing strategies that lead to
clinical pharmacology, design of mechanistic studies and profiling
packages that meet regulatory requirements and support differentiated
and competitive drug labeling• Provide scientific expert assessments
and support for in-licensing opportunities, including due
diligencesYour responsibilities:Translational Medicine early clinical
projects:In collaboration with your Translational Medicine Therapeutic
Area Head or other Translational Medicine Experts• Develop high value
decision-strategies for the Translational Medicine component of drug
development projects from Research to clinical Proof of Concept or
Proof of Mechanism in a single or multiple indications, including
Parallel Indication Expansion-Proof of Concepts- Represent TM and lead
global project teams through First in Human and Proof of Concept phase
to drive strategy that enables development- In collaboration with
research scientists, contribute to the proposal of new targets or
indications for existing compounds; identify, develop, and implement
strategy for preclinical support of clinical program-related
scientific objectives. This includes assessment of medical need,
proposal of clinical development pathways, and review of preclinical
data for clinical implications, and other relevant activities-
Responsible for implementing studies during the Proof of Concept phase
by providing medical and scientific leadership and expertise to all
line functions on the project team. This may include methodology
studies to identify and validate novel endpoints for early decision
making. - Responsible for clinical portions of the Integrated
Development Plan, including the Clinical Development Plan and Clinical
Pharmacology Plan• Accountable for compound and disease related
biomarker strategies, working closely with Biomarker Experts in
implementation• Develop and implement study protocols for different
types of clinical studies (First in Human, Proof of Concept,
mechanistic and safety studies), and other documents such as
investigators brochures.• Responsible for clinical monitoring and
integrated safety data review during and after the live phase of a
study• Provide medical and scientific leadership and expertise to all
line functions on the study team• Leadership- Lead study-specific
teams/ clinical trial teams- Represent TM or lead BR project teams•
Represent clinical Translational Medicine aspects to Health
Authorities and other stakeholders (e.g. payers, patient advocacy
groups)• Represent clinical Translational Medicine in reviews of
external opportunities• Oversee publication and external presentation
of study results• Innovation: Champion and drive new clinical compound
characterization opportunities and profiling approaches• Contribute to
initiatives that drive innovation, quality, and efficiency across
Translational MedicineTranslational Medicine late-stage clinical
projects:In collaboration with your Translational Medicine Disease
Area Head:• Drive analysis of studies and present results to relevant
decision boards• Communicate clinical team matters to Global Project
Teams, relevant Novartis BioMedical Research and Global Development
boards, and other Novartis Boards as required.• Evaluate clinical
centers and foster communication with crucial collaborating
investigators, regulatory authorities, and other stakeholders• Provide
support for dose selection, design and other clinical pharmacology
matters throughout the development cycle• Responsible for content and
authoring of documents needed for submission documents with
Translational Medicine input (CO, SCE, SCS, SCP, SBP) of NDAs, sNDAs,
MAAs, BLAs from regulatory submission through drug registration,
including advisory committee and scientific advice group meetingsKey
Performance Indicators:• Delivery of proposed Development Candidates,
Integrated Development Plan Approval and Development transition point
milestones, and early clinical study results, according to timelines•
Team leadership skills that create high performing teams and drive
efficient conduct of innovative, interpretable clinical results•
Strong adherence to and modeling of Novartis values and behaviors•
Quality of contribution to disease area strategy discussions and
contribution to Clinical Pharmacology plans / Profiling strategy
discussions and external collaborationsMatrix people responsibility
per project: 5-8 cross-functional members from within Translational
Medicine plus other line functions per project teamImpact of this
role?• Design and implementation of early Clinical Development Plan
and studies according to the Integrated Development Plan / Clinical
Development Plan / Clinical Pharmacology Plan enabling efficient and
rational decision-making, high probability of fast drug registration,
favorable drug label and high competitiveness of compounds• This role
has a key impact on the entire Novartis pipeline, transitioning
programs from preclinical through early clinical and ultimately to
full development via First in Human, Proof of Concept, and driving the
program after Proof of Concept by delivering key Profiling data to
support regulatory submissions• Recognized Expert in field, drives
project team clinical strategy. Works globally across Novartis as well
as country organizations as appropriateCommitment 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’ll bring to the role: •
Medical Degree and additional PhD/post-doctoral equivalent immunology
research• Specialized further training (board certification) and / or
clinical research experience in dermatology / immunology preferred•
Advanced / business-level / fluent English (oral and written)•
Recognized for medical expertise: demonstrated excellence and clinical
/ patient expertise in dermatology / immunology• Recognized for
scientific expertise: respected by colleagues internally and
externally, you’ve made significant contributions to your field and
created / established new concepts; record of high quality
publications in international scientific journals.• Previous relevant
& significant clinical study experience: either from pharma/biotech
leading early phase clinical trials; a senior role within a CRO
responsible for leading the medical relationship with Sponsors; from a
relevant academic medical center with PI & co-PI clinical trial
experience. You are used to working independently and within teams
including scientists and non-scientists on study planning and
execution, demonstrating competence in a broad range of project and
more strategic planning skills• Excellent written and oral
communication/presentation skills, used to distilling and effectively
conveying significant messages to different audiencesYour behavioral
characteristics• Demonstrated passion for treating patients and
science• Strategic thinker: you have created major innovations,
networked with and influenced external medical leaders with your clear
and logical presentation of complex strategic issues• Innovation: a
curious mind and a natural instinct to seek out new clinical discovery
opportunities and clinical study approaches• Results-driven
self-starter and decision taker; good planning, prioritization,
problem solving and organizational skills; strong cooperative team
player, flexible in a changing environment; Resilient, energetic and
enthusiastic; responding constructively to challenging new ideas and
inputThis position is written for Director - we can hire Executive
Director for those with significant Pharma careers, or Associate
Director if you have limited clinical study experience or a less
established scientific record but have already demonstrated impactful
new thinking and innovative clinical & scientific approaches within
your career.ABOUT TRANSLATIONAL MEDICINE:Translational Medicine is a
global group of scientists and Physicians working at the pre-clinical
and early clinical stage of drug discovery. Our Physician-Scientist
Discovery & Profiling group drives innovative and cutting–edge science
from Discovery to the market through the selection, profiling and
effective global development of successful medicines. The group closes
the gap between preclinical research and clinical development and
integrates clinical science into the discovery and preclinical
development phase. Our Translational Medicine concepts are driven by
medical needs of the patient and the concept of personalized medicine,
tailoring the drug, its dose and dosing regimen in such way to the
patient that the clinical response is optimal in terms of efficacy and
safety. We focus from identification of drug targets (molecular
pathways relevant to disease) up to the completion of Proof of Concept
(Phase IIa studies). Our Translational Medicine Experts are part of
preclinical project teams in all drug discovery phases and help design
the pathway for First in Human studies (healthy volunteer) that bridge
to studies in the patient population. They have the comprehensive
responsibility for designing and executing the early clinical drug
development phase together with a project team from researcher,
biomarkers, biostatistics, modeling and simulation, toxicology,
technical experts and the clinical trial teams.DivisionBiomedical
Research Business UnitTranslational Medicine Work LocationBasel
Company/Legal EntityNovartis Pharma AGFunctional AreaResearch &
Development Job TypeFull TimeEmployment TypeRegular Shift WorkNoEarly
TalentNoCountry: Switzerland