Alder Biopharmaceuticals, Inc.

Scientist, Nonclinical

Alder Biopharmaceuticals is seeking an experienced, detail-oriented scientist to conduct nonclinical activities and assist in the preparation of regulatory documentation related to nonclinical aspects of therapeutic monoclonal antibody drug development.

Specific responsibilities will include:

• Monitoring nonclinical in vitroand in vivotoxicology, pharmacology, and pharmacokinetic studies including but not limited to: acute, chronic, reproductive, carcinogenicity, cardiovascular, immunogenicity, and special studies.
• Plan and monitor activities occurring at multiple Contract Research Organizations (CROs) in support of Alder’s development programs relating to the conduct of nonclinical studies to ensure on-time and on-budget completion of high quality GLP-compliant Final Reports.
• Coordinate between various Alder BioPharmaceutical operational units including Research, Quality Assurance, Regulatory, and Manufacturing to assure the successful execution of nonclinical activities.
• Review nonclinical reports supporting the development and ultimate registration of Alder BioPharmaceutical products.
• Prepare and review various regulatory documents including Investigational New Drug applications (IND), Investigator Brochures (IB) and Biological License Applications (BLA) as required to support drug development.
• Conduct daily activities as described by relevant Alder BioPharmaceutical SOPs.

Qualifications:

• A graduate degree in life science or Bachelor's degree plus equivalent experience.
• Minimum of 5 years experience in the design and conduct of nonclinical studies in a similar position with a successful record of managing outside vendors to ensure regulatory compliance and in support of product registration.
• Experience in the conduct of nonclinical studies necessary to support antibody drug development is required.
• A detailed understanding of current GLP practices and nonclinical regulatory issues is a must.
• This position requires excellent written and interpersonal communication skills as well as the ability to function in a fast-paced, team-oriented environment.

To apply for this position, please visit: https://goo.gl/cZucXC

Alder Biopharmaceuticals, Inc.
Reference Job Code: R18-203

Alder Biopharmaceuticals, Inc. is an Equal Opportunity Employer

Submitted: 02/19/2019