Executive Medical Director, Late 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.

The Opportunity

Denali Therapeutics seeks to recruit an Executive Medical Director in late-stage clinical development to provide clinical development leadership in Mucopolysaccaroidsis 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.

Key Accountabilities/Core Job Responsibilities:

• Provides clinical leadership for the development program in MPS II, including design, analysis, and interpretation of pivotal trials and market authorization 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 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 integrated interpretation and reporting of efficacy and safety across the clinical trial program

• Partner seamlessly with program management, biometrics, regulatory, clinical operations, development sciences, drug safety, and other development functions to ensure successful delivery of the development program and filing activities

• 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:

• 10-12 + years industry experience with leadership and technical management across one or more core Development functions (clinical, biometrics, regulatory)

• Leadership experience in a global environment with local leadership experience in Europe and experience collaborating with US based teams

• Therapeutic area knowledge and familiarity with Neuroscience and Rare Disease highly desired

• Sub-specialization and/or clinical development experience in Parkinson's Disease is highly desirable

• Differentiated communication skills with ability to communicate on topics spanning clinical, biomarker, regulatory, and commercial topics

• Track record of excellence in people management

Salary Range: $332,000.00 - $375,000.00. 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.

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.

Applicant Privacy Policy

https://www.denalitherapeutics.com/denali-applicant-privacy-policy