Senior Manager, Bioanalytical

Mirum Pharmaceuticals•Foster City, CA

2d•Hybrid

About The Position

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.

Requirements

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 hands-on laboratory experience operating LC-MS/MS systems (or other quantitative instrumentation) and conducting sample preparation and analysis
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

Nice To Haves

Prior experience with assets in liver, neurology, or rare disease indications is a plus

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