What are the responsibilities and job description for the Vice President, ETV Portfolio, Late Clinical Development position at Denali Therapeutics Inc?
Neurodegenerative 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.
Key Accountabilities/Core Job Responsibilities:
Responsible for the development and execution of development programs in the ETV portfolio, including pivotal trials and future filing activities
Collaborate with other Denali clinical, translational, clinical pharmacology, safety, and other technical experts to integrate PK/PD, diagnostic, biomarker and safety plans into the overall clinical development strategy
Oversee 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 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
Collaborate with academic scientists, clinical experts, and study investigators
Represent and advocate for the project in internal and external venues
Act as a champion for high standards of compliance, ethics and safety, and putting patients first
Manage and supervise clinical science team members in executing responsibilities; lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
Qualifications/Skills:
MD or MD-PhD, with formal training in neurology or relevant disease area preferred
20 years' industry or related clinical development and academic experience, preferably in neurological rare disease, including 15 years' experience leading cross-functional development teams and/or people management experience
Demonstrated excellence and experience in late-stage clinical development in neurological indications, including the design, execution, and reporting of pivotal trials and NDA/BLA/MAA filing experience
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 people management
Demonstrated success in engaging regulatory approval agencies at end of Phase 2, NDA/BLA submission, and drug approval milestones
Post-marketing clinical development, medical affairs, or drug safety experience is a plus
This position is based in South San Francisco, CA, and may require travel up to 25% of the time in the future
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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.
Salary : $377,775 - $441,324
