Senior Manager, Clinical Quality

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.

Responsibilities

• Serve as GCP Quality team member on the Study Execution Team(s) as assigned.

• Track and prepare updates on quality issues. Provide CQA advice and risk-based strategic guidance based on analysis and interpretation of GCP regulations.

• Responsible for identifying quality and compliance issues and actively finding solutions

• Manage QA reviews of essential clinical trial documents (manual, study plans) for compliance with regulations.

• Drive inspection readiness activities within the SET.

• Advise and coach study teams to ensure compliance with internal and external policies, laws, and regulations.

• Assist in the development of CAPAs with an emphasis on root cause analysis.

• Participate in the evaluation and selection of CROs and other clinical vendors as assigned.

• Promote collaboration internally and with external partners to ensure systems and processes comply with applicable standards, regulations, and guidelines.

• Support the preparation and conduct of clinical inspections by Regulatory Agencies and partner audits as assigned.

• Assist in implementing internal processes and systems related to GCP QA

• Make recommendations for improvements to the QMS to bolster compliance across all studies

• Participate in the development and delivery of GCP training internally

• Represent CQA in internal presentations on quality issues, initiatives, and projects

• Maintain knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organization

• Participate in and support various development teams

• Provide direct support to clinical study teams and participate in QA planning and implementation to support study operations

• Ensure Clinical Development activities are compliant with GCP, FDA, ICH, and other applicable regulations and guidelines and industry standards

• Review key safety, clinical and regulatory documents, such as DSUR, Protocol, IB, IND and NDA

• Support clinical quality oversight activities for multiple programs within Clinical Development

• Assist with preparations for GCP inspection-readiness at CROs and investigator sites.

• Contribute to the development, implementation, and maintenance of GCP Quality Systems and SOPs

• Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study

Basic Qualifications

• 6+ years working in GCP QA

• Working knowledge of ICH E6(R2) GCP guidelines, FDA Code of Federal Regulations, and other global applicable laws and regulations

• Experience applying risk-based methodology and working within the QMS framework

• Knowledge of clinical trial systems and processes

• Attention to detail and accuracy in work, while delivering on deadline

• Excellent verbal, written communication, and interpersonal skills

• Work according to procedures, guidelines, and regulations

• Critical thinker with ability to synthesize information from multiple sources and apply to problem-solving

• Positive, self-starter and thrives under pressure

• Able to work across multiple projects and prioritize tasks as required

Salary Range: $165,000.00 - $198,333.00. 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.

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