Senior Manager, Bioanalytical

POSITION SUMMARY

The Senior Manager, Bioanalytical will be responsible for all aspects of bioanalytical in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

 JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the bioanalytical lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of nonclinical and clinical bioanalytical studies for all Mirum assets
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the completion of the relevant sections of IND, NDA, MAA, other regulatory documents and works closely with Regulatory to support clinical document submission
• Provides CROs with technical oversight as needed and ensures that assay development, validations, sample analysis, and data transfers occur at CROs and in-house to meet project goals

QUALIFICATIONS

Education/Experience:

• BS in Biological Sciences and minimum of 6-8 years of relevant experience, or an advanced degree (MS, PhD) with fewer years of experience
• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Prior hands-on laboratory experience operating LC-MS/MS systems (or other quantitative instrumentation) and conducting sample preparation and analysis

 Knowledge, Skills and Abilities:

• Strong knowledge of GLP/GCLP compliance in supporting nonclinical and clinical studies
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Functions efficiently, effectively and at times independently
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience coordinating studies through CROs
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

 The salary range for this position is $200,000 to $220,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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