Biotechnology, Pharmaceuticals, Rare Diseases

Director, Clinical Pharmacology

Foster City, CAHybridFull TimeDirector$230,000–$250,000 /yrPosted 26 days agoVisa sponsorship available

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Required skills

clinical pharmacology
drug development
regulatory documents
IND
NDA
MAA
PK
PD
PopPK
PBPK

Nice to have

liver
neurology
rare disease
small molecule
antibody
ADC

Role summary

Mirum Pharmaceuticals is seeking a Director of Clinical Pharmacology to lead all aspects of clinical pharmacology for rare disease assets. This role involves defining strategy, overseeing study execution through CROs, and representing clinical pharmacology on multidisciplinary teams. Responsibilities include designing and executing clinical pharmacology strategies, managing CRO collaborations, authoring regulatory documents, and contributing to due diligence efforts. The ideal candidate will have expertise in PK/PD assessments, regulatory guidance, and experience with IND/NDA/MAA filings. Prior experience in liver, neurology, or rare disease indications is a plus.

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.

#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.

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Director, Clinical Pharmacology

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