Senior Manager, Development Sciences Operations

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

The Opportunity

The company is seeking an experienced and highly motivated Development Sciences Operations Manager/Sr. Manager responsible for oversight of technical and operational aspects supporting Toxicology, Pathology,  Biomarker, Bioanalytical, and DMPK/Clinical Pharmacology functions. This individual will work in close collaboration with Denali colleagues in Discovery Research, Development Sciences, and Clinical Operations and will be responsible for  liaising with Contract Research Organizations (CROs), monitoring external nonclinical studies, managing vendor relationships and contracts, and will contribute to the design, execution, and reporting of nonclinical studies for Denali Therapeutics products.

Responsibilities

• Serve as Safety Assessment (Toxicology/Pathology), DMPK, Clinical Pharmacology, Biomarker, and Bioanalytical function interface between Denali and external CRO collaborators, developing productive relationships and leading efforts to achieve optimal efficiency in external workflows and ensuring compliance GLP, GCP and GCLP regulations.
• Manage identification (RFI) and selection process of clinical bioanalytical vendors, partnering with Legal and Contracts group in managing the operational aspects of pre-clinical and clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets.
• Independently manage study operational logistics, including establishing timelines for deliverables, facilitate test material logistics, and support the trafficking of samples, data, and documents
• Provide support in implementing, managing, and monitoring outsourced nonclinical Toxicology studies (non-GLP and GLP) to support all phases of drug development
• Partner with Bioanalytical and Biomarker Scientists to manage development, optimization, method transfer, and method qualification/validation activities to enable quantification of drug and biomarkers in preclinical and clinical studies.
• Ensure data and reports are integrated into internal databases.
• Responsible for working with DMPK scientists to identify CRO laboratories capable of conduct of in vitro and in vivo experiments supporting candidate identification and IND-enabling efforts.
• Engage CROs and internal scientists to outline protocols/SOWs.
• Manage timelines to deliver according to project team goals.
• Receive and review study results and summary reports, ensuring data and reports are integrated into internal databases; help design tools to aid in data upload, migration, and visualization.
• Ensure compliance with study protocols, IACUC regulations, and SOPs.

Requirements

• BS/MS in Pharmacology, Toxicology, Analytical Sciences, Pharmaceutical Sciences, or related scientific discipline with 3-5 years of biopharmaceutical operations experience.
• Working knowledge of bioanalysis concepts applied to method development and sample testing of therapeutic or biomarker analytes a must.
• Experience monitoring Toxicology studies.
• Experience with regulated studies and understanding of clinical sample management and data transfer workflows.
• Excellent critical thinking and scientific skills, with demonstrated ability to review, summarize, and communicate complex Bioanalytical and DMPK data;
• Ability to perform data entry into data warehouses (e.g., Dotmatics/Benchling) and manage data visualization software (Tableau, SEND explorer).
• Outstanding organization and planning skills, and the ability to assess risks and manage external workflows to meet project team deliverables.
• Excellent analytical, critical thinking, and interpersonal skills to build collaborative relationships enabling effective professional interactions with vendors and stakeholders.
• Proven ability to thrive in a collaborative fast-paced team environment: strong oral and written communication skills, and a helpful team spirit.

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: $170,000.00 to $202,000.00. 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 p