What are the responsibilities and job description for the Principal Clinical Scientist, Early 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.
As a Principal Clinical Scientist, you are responsible for supporting the design and execution of early stage (Phase 1/2) clinical and/or rare disease trials including safety, biomarker and clinical outcomes. 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 to this role.Key Accountabilities/Core Job 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, responses to regulatory authorities and other key clinical and regulatory documents
Ensuring high quality clinical trial conduct and data collection (e.g. safety, biomarker, imaging and COA data) through on-study clinical data monitoring
Partnering with clinical operations and other teams for successful execution of clinical studies
Working closely with medical monitor on clinical activities, monitoring the safety of trials, and clinical site interactions
Reviewing and analyzing clinical data
Engaging in topical literature review on discrete topics to support development program success
Representing clinical science on cross functional teams
Qualifications/Skills:
BS/MS degree (science based) is required with PharmD, PhD, 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 a plus
Experience in 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
"Can do," "pitch in" positive attitude
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 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.
