Senior Manager, Bioanalytical

Posted 6 Days Ago
Be an Early Applicant
Foster City, CA, USA
In-Office
200K-220K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Manager, Bioanalytical oversees bioanalytical studies for drug development, manages CRO collaborations, ensures regulatory compliance, and supports clinical submissions.
Summary Generated by Built In

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.


Skills Required

  • BS in Biological Sciences or advanced degree (MS, PhD) with relevant experience
  • Minimum of 6-8 years of relevant experience
  • Hands-on laboratory experience operating LC-MS/MS systems and conducting sample preparation and analysis
  • Strong knowledge of GLP/GCLP compliance
  • Solid project management skills including budget and schedule management
  • Strong communication and interpersonal skills

Mirum Pharmaceuticals Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Mirum Pharmaceuticals and has not been reviewed or approved by Mirum Pharmaceuticals.

  • Equity Value & Accessibility Equity grants to new hires and an employee stock purchase plan make ownership more accessible and can boost total rewards when performance is strong. Public disclosures highlight frequent option/RSU inducements.
  • Healthcare Strength Comprehensive medical, dental, and vision coverage is employer-paid for employees, with added life, disability, and EAP support. This combination reduces financial burden and enhances overall wellbeing.
  • Leave & Time Off Breadth A broad time-off program includes multiple paid company holidays, a year-end shutdown, accrued vacation, and paid parental leave. This breadth provides additional rest periods beyond standard vacation.

Mirum Pharmaceuticals Insights

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The Company
HQ: Foster City, CA
200 Employees
Year Founded: 2018

What We Do

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Mirum’s approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. Maralixibat (LIVMARLI), an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the MARCH Phase 3 study for progressive familial intrahepatic cholestasis (PFIC) and the EMBARK Phase 2b study for patients with biliary atresia. In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome. Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome. Mirum’s second investigational treatment, volixibat, also an oral IBAT inhibitor, is being evaluated in three potentially registrational studies including the OHANA Phase 2b study for pregnant women with intrahepatic cholestasis of pregnancy, VISTAS Phase 2b study for adults with primary sclerosing cholangitis, and the VANTAGE Phase 2b study for primary biliary cholangitis.

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