Senior Scientist, Bioanalytical Sciences Details

Senior Scientist, Bioanalytical Sciences

Denali Therapeutics - South San Francisco, CA

Employment Type : Full-Time

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.

The Opportunity

Denali Therapeutics is seeking a Senior Scientist, Bioanalytical Sciences, responsible for establishing bioanalytical methods to support discovery and development of novel blood brain barrier (BBB) penetrant biotherapeutics and small molecules, as well as key clinical biomarkers.

Working collaboratively with colleagues in Discovery, Development Sciences, Translational Sciences, and Clinical Development, you will design and execute bioanalytical methods and successfully deliver bioanalytical results for PK/PD, toxicology, and clinical studies, while adhering to relevant regulatory guidelines, when appropriate.

You will also serve on cross-functional Project Teams, prepare relevant sections of regulatory filings, and participate in interactions with global health authorities.

Responsibilities

• Establish bioanalytical methods for novel, complex biotherapeutics (eg, engineered immunoglobulins, fusion proteins, and nucleic acids), including measurement of drug concentrations and anti-drug antibodies.
• Manage bioanalytical CROs on method optimization, assay transfer, qualification/validation, and sample analysis to ensure delivery of bioanalytical results within project timelines.
• Write, review, and finalize bioanalytical study reports that adhere to global regulatory guidelines and are suitable to support IND/CTA/BLA/NDA filings.
• Analyze, interpret, summarize, and present data to internal Project Teams, senior management, and global health authorities; prepare regulatory summary documents, briefing packages, and immunogenicity risk assessments.
• Assist in devising innovative, effective bioanalytical strategies for progressing Denali's biotherapeutic BBB portfolios. Contribute to bioanalytical budget and resource planning.

Basic Qualifications

PhD or PharmD in in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific discipline and 4+ years of biotechnology or pharmaceutical drug development experience

OR

Master's degree and 7+ years of biotechnology or pharmaceutical drug development experience

OR

Bachelor's degree and 10+ years of biotechnology or pharmaceutical drug development experience

Preferred Qualifications

• Hands-on experience in bioanalysis of novel, complex biotherapeutics (eg, engineered
• antibodies, fusion proteins, and nucleic acids) and biomarkers.
• Knowledge and understanding of bioanalytical tools and instrumentation (eg, MSD,
• biosensors, Watson LIMS, Gyro, and Bravo).
• Well-versed in regulatory guidance (FDA, EMA, and ICH) covering bioanalysis of
• biotherapeutics and biomarkers.
• Experienced in design and conduct of bioanalytical method development and assay
• qualification / validation supporting regulated and clinical studies.
• Excellent critical thinking and scientific skills, and ability to analyze, interpret, and
• clearly communicate complex bioanalytical data.
• Ability of work effectively and collaboratively on cross-functional Project Teams and
• with CROs.
• Excellent oral presentation and written communication skills.
• Expertise in neuroscience indications and/or oligonucleotide drug development.

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.

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