Executive Medical Director, ETV Franchise

Vor 2 Tagen


Zürich, Schweiz Denali Therapeutics Inc. Vollzeit

Executive Medical Director, ETV Franchise page is loaded## Executive Medical Director, ETV Franchiselocations: Zurichtime type: Full timeposted on: Posted Todayjob requisition id: R-1427Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.The Executive Medical Director for the ETV Platform is responsible for developing and leading the clinical strategy for product development, managing clinical trials from design to execution, providing medical and scientific leadership to cross-functional teams and external stakeholders, and ensuring regulatory compliance. This role also requires expertise in pediatric rare diseases, including understanding the competitive landscape and evidence gaps, as well as strong skills in data interpretation, analysis, scientific communication, and clinical team leadership.**Key Accountabilities and Core Responsibilities:*** Provide clinical leadership for an ETV pediatric rare disease drug development program in a cross-functional team environment* Collaborate with translational sciences, clinical pharmacology, drug safety, biometrics, and other technical experts on the overall development program* Develop and lead the clinical strategy for the investigational agent including target product profile and clinical development plan* Serve as an author and lead the development of study protocols and clinical study reports, and other clinical-regulatory documents* Oversee the clinical science aspects of design, execution, interpretation and reporting of efficacy and safety across the stages of clinical trials* Collaborate with academic scientists, clinical experts, and study investigators* Ensure steadfast compliance with all international guidelines (GCP and ICH), emphasizing the paramount importance of ethics, patient safety, and well-being* Contribute scientific knowledge and leadership to the clinical science function* Serve as medical resource for clinical issues raised by internal and external collaborators, investigators, and consultants* Review, interpret and present clinical data to internal and external stakeholders* Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations* Provide oversight and medical monitoring for clinical trials, including implementation of ITI strategy and IRR guidance and management.* Contribute collaboratively with the team toward achievement of program goals* Maintain compliance with training**Experience and Qualifications:*** MD or MD-PhD, with formal training in the areas of pediatrics, genetics, rare disease and/or neurology preferred* 12+ years industry or related clinical research experience, preferably in neurological rare disease, including 10+ years' of experience leading cross-functional development teams and/or people management experience* Demonstrated excellence and experience in clinical development in neurological indications* Study design, execution, and reporting of clinical trials across the spectrum of drug development phases* Ability to communicate effectively with clinical, biomarker, biostatistical, and pre-clinical scientists, including peer to peer interactions with academic scientific experts* Track record of excellence in working collaboratively in a team environment* Demonstrated success in engaging regulatory agencies in end of Phase 2, pre-Phase 3 and NDA/BLA submission, or other drug approval milestones* Target identification, drug-safety, post-marketing clinical development, or medicalaffairs experience desirableCompensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a pension, medical stipend, equity and a broad range of other benefits.Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.“Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.
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