Mirum Pharmaceuticals

ASBT inhibitors for rare liver diseases

Director – Clinical Pharmacology

Biology & BiotechConfirmed live in the last 24 hours

Full-timeFoster City, CA, USA$230k - $250kHybrid

About the Job

Requirements

Experience with assets in liver, neurology, or rare disease indications is a plus.
Experience with therapeutic modalities including small molecules, antibodies, and antibody-drug conjugates.
A Bachelor of Science in Biological Sciences with 12–15+ years of experience, or a PhD or PharmD with 10+ years of experience in clinical pharmacology.
Proficiency in designing, executing, and interpreting clinical pharmacology studies, including pharmacokinetic and pharmacodynamic assessments.
Thorough understanding of clinical pharmacology requirements and regulatory guidance for drug development.
Experience authoring and supporting regulatory filings, including IND, NDA, and MAA submissions.
Experience coordinating studies through contract research organizations.
Knowledge of good clinical practice compliance in clinical studies.
Proficiency in written and verbal regulatory interactions.
Knowledge of population pharmacokinetic modeling, physiologically based pharmacokinetic modeling, exposure-response analysis, or PK/PD modeling.
Project management skills, including creating and managing project plans, budgets, and schedules.
Strong written and verbal communication and interpersonal skills, with the ability to communicate across organizational levels.
Ability to work independently, stay organized and flexible, manage multiple activities, and maintain attention to detail.

Responsibilities

Serve as the clinical pharmacology lead on project and study teams, providing subject matter expertise for clinical development programs.
Lead the design and execution of clinical pharmacology strategy, including study design, planning, oversight, data analysis, interpretation, and reporting, to support key decisions and milestones such as dose selection.
Manage collaborations with contract research organizations and consultants, provide technical oversight, and ensure timely, high-quality deliverables.
Lead authoring clinical pharmacology sections of regulatory documents, including clinical study protocols, clinical study reports, Investigator’s Brochures, INDs, NDAs, MAAs, briefing materials, and responses to queries.
Support due diligence for potential drug in-licensing or partnership opportunities by reviewing existing data and developing clinical pharmacology strategy.

Desired Qualifications

Prior experience with assets in liver, neurology, or rare disease indications.

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 Director of Clinical Pharmacology will be responsible for all aspects of clinical pharmacology in the development and approval of Mirum rare disease assets. As a key member of the small Development 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 clinical pharmacology lead on project and study teams, providing subject matter expertise on clinical development programs
Leads the design and is responsible for the execution of the clinical pharmacology strategy (from study design, planning, and oversight to data analysis, interpretation, and reporting) in support of key decisions/milestones (e.g., dose selection)
Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
Leads the authoring of clinical pharmacology sections of regulatory documents (clinical study protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, response to queries)
Plays a key role in due diligence efforts for potential drug in-licensing or partner opportunities, including review of existing data and development of clinical pharmacology strategy

QUALIFICATIONS

Prior experience with assets in liver, neurology, or rare disease indications is a plus
Experience with various therapeutic modalities (small molecule, antibody, ADC)

Education/Experience:

BS in Biological Sciences with 12-15+ years or an advanced degree (PhD, PharmD) with 10+ years of experience in clinical pharmacology

Knowledge, Skills and Abilities:

Proficiency in the design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments
Thorough understanding of clinical pharmacology requirements, including regulatory guidance, to support drug development
Proven track record of success as both an individual contributor and a collaborative team member
Experience authoring and supporting regulatory filings (IND, NDA, MAA)
Experience coordinating studies through CROs
Solid knowledge of GCP compliance in supporting clinical studies
Proficient in regulatory interactions both written and verbal
Knowledge of PopPK, PBPK, exposure-response, or PK/PD modeling
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
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 $230,000 to $250,000USD. 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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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 the Company

Mirum Pharmaceuticals

ASBT inhibitors for rare liver diseases

Mirum develops therapies for rare liver diseases, led by LIVMARLI (maralixibat), an oral ASBT inhibitor that reduces bile acid buildup and itching in Alagille syndrome and other cholestatic conditions. It is pursuing LIVMARLI for additional rare diseases such as PFIC and biliary atresia and developing volixibat for primary sclerosing cholangitis and primary biliary cholangitis. The company combines drug development with commercialization in the United States and other major markets, working with physicians, payers, and patient groups to improve access. Its goal is to bring effective therapies to patients with rare liver diseases and build a sustainable commercial presence in key markets.

Company size: 501-1,000
Company stage: IPO
Headquarters: Foster City, CA
Founded: 2018

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