Senior Clinical Scientist

$165,000 - $204,333/Yr

Denali Therapeutics - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

Professional, Scientific, and Technical Services

About the position

The Senior Clinical Scientist at Denali Therapeutics plays a crucial role in the development of clinical protocols and study-related materials for neurodegenerative disease therapies. This position involves leading clinical trial conduct, ensuring high-quality data collection, and collaborating with cross-functional teams to execute clinical studies effectively. The role requires strong communication skills and a deep understanding of clinical data analysis and regulatory processes.

Responsibilities

• Contributing to or leading the development of clinical protocols, informed consents, and other study-related materials.
• Drafting clinical sections of study reports, investigator brochures, and responses to regulatory authorities.
• Ensuring high-quality clinical trial conduct and data collection through on-study clinical data monitoring.
• Partnering with clinical operations and other teams for successful execution of clinical studies.
• Working closely with the medical monitor on clinical activities and monitoring the safety of trials.
• Reviewing and analyzing clinical data.
• Engaging in topical literature review to support development program success.
• Representing clinical science on cross-functional teams.

Requirements

• BS/MS degree (science-based) is required; PharmD, PhD, or MD preferred.
• 7+ years of industry experience.
• Strong oral/written communication skills.
• Demonstrated experience in protocol authoring, study startup, study execution/monitoring, and data review activities.
• Experience contributing to global regulatory filings such as INDs or CTAs; experience in NDA or BLA filings is a plus.
• Experience in the implementation of biomarkers and/or imaging in clinical trials is highly desirable.
• Skilled in scientific data analysis, interpretation, and results reporting.
• Therapeutic experience in neurology, rare diseases, or pediatrics preferred.
• Ability to work independently and collaborate on cross-functional teams is required.
• Positive attitude with a 'can do' approach.

Nice-to-haves

• Experience in NDA or BLA filings.
• Experience in the implementation of biomarkers and/or imaging in clinical trials.
• Therapeutic experience in neurology, rare diseases, or pediatrics.

Benefits

• 401k
• healthcare coverage
• Employee Stock Purchase Plan (ESPP)
• broad range of other benefits