Executive Medical Director, Late Clinical Development
Executive Medical Director, Late-Stage Clinical Development
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to the genetics and biology of neurodegeneration and biomarker driven development in areas of high unmet medical need.
Denali Therapeutics seeks to recruit an Executive Medical Director in late-stage clinical development to provide clinical development leadership in Mucopolysaccharidosis II II (MPS II, Hunter syndrome), a rare condition with neurodevelopmental and systemic disease impacts. The Executive Medical Director will be responsible for the oversight of clinical development program in MPS II. Demonstrated success in conducting registrational clinical trials in rare disease, global regulatory experience including filing for marketing authorization, and cross-functional team leadership experience are critical to success in this role. Full understanding of the relevant compliance framework for clinical development activities, entrepreneurial drive to help the organization succeed, and passion for science and patients are essential.
- Responsible for the development and execution of a development program in MPS II, including pivotal trials and 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
- Manage clinical science team members
- 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
- MD or MD-PhD, with formal training in the areas of pediatrics, genetics, and/or neurology preferred
- 7+ years’ industry clinical development experience, preferably in neurological rare disease, including 3+ years’ experience leading cross-functional development teams and 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
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 Range: $321,000 to $375,000. Compensation 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 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*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.