Senior Manager, Bioanalytical

Mirum Pharmaceuticals, Inc.

Salary: $200k - $220k
Experience: 6+ yrs
Location: Foster City, California, United States
Job type: Full-time

Required skills

LC-MS/MS
chromatography
sample preparation
data analysis
regulatory documents
IND
NDA
MAA

About the role

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

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.

#LI-HYBRID

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

About Mirum Pharmaceuticals, Inc.

Develops and commercializes therapies for rare liver diseases.

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