Senior Medical Director, ALS- Late Stage Development
Denali Therapeutics
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative
diseases through our deep commitment to the genetics and biology of neurodegeneration and
the principles of translational medicine.
The Opportunity
Denali Therapeutics seeks to recruit a Senior Medical Director in late-stage clinical development
to provide clinical development leadership in Amyotrophic Lateral Sclerosis (ALS), a rare and
progressive neurodegenerative disease affecting motor neurons. The Senior Medical Director
will be responsible for providing clinical leadership of the development program in ALS.
Demonstrated success in the design, conduct, and analysis of Phase 2 and Phase 3 clinical trials
and experience in clinical leadership on a cross-functional team are critical to success in this
role. Full understanding of the relevant framework for clinical development activities, an
interest in engaging with the ALS scientific community and investigators, and a passion for
improving the lives of individuals living with ALS are essential.
Responsibilities:
● Responsible for working collaboratively in a multi-function team towards the
development and execution of a clinical trial program in ALS
● Clinical leadership in the development and management of study protocols and clinical
study reports, study medical monitoring, safety reporting, and clinical-regulatory
documents
● Responsible for clinical science aspects of design, execution, interpretation and
reporting of efficacy and safety across the clinical trial program
● Provide clinical expertise and represent the clinical development program in global
health authority document preparation and interactions
● Provide medical surveillance on Adverse Event (AE), Serious Adverse Event (SAE)
reporting, and follow-up
● Partner seamlessly with program management, biometrics, regulatory, clinical
operations, development sciences, drug safety, and other development functions to
ensure successful development program delivery
● Represent clinical development program with external academic scientists, clinical
investigators, advocacy, and other stakeholders
Requirements
●MD or MD-PhD, with formal training in neurology preferred
● Specific expertise and experience in ALS is highly desirable5+ years industry clinical development experience, preferably in neurological disease,
including experience leading clinical development in a cross-functional team environment
● Demonstrated excellence and experience in late-stage clinical development in
neurological indications, including the design, execution and reporting of pivotal trials;
NDA/BLA/MAA filing experience a plus
● Less industry experience may be acceptable depending on prior academic and/or clinical
trial experience
● Ability to communicate effectively with data management, biostatistical, safety,
regulatory and other functional team members
● A strong track record in team leadership, development of clinical-regulatory strategies,
and/or industry-academic collaborations
● This position is based in Zurich, Switzerland and may require travel up to 25% of the
time in the future
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