Job Application for Director, Clinical Operations at Mirum Pharmaceuticals

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, Clinical Operations is responsible for providing leadership to assigned clinical program(s) and for ensuring studies within a program are being managed in accordance with the Mirum’s overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a clinical program comply with the company’s procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Director, Clinical Operations is also responsible for the development and implementation of clinical best practices for effective clinical study execution in accordance with regulations and from time to time may lead strategic and continuous improvement initiatives in clinical project execution and project management.

JOB FUNCTIONS/RESPONSIBILITIES

Provides leadership in the development of the clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Program Lead.
Collaborates with the SVP, Clinical Operations, to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
Provides leadership to Clinical Projects to ensure trial/study teams, are managed in alignment with clinical program and Mirum goals.
Provides Clinical Program updates, including trial status/metrics, budget, accomplishments and risks to SVP, Clinical Operations, Program Team Leads, Program Managers, Senior Management and other relevant stakeholders.
Responsible for the strategic and operational oversight, management, execution and delivery of the clinical studies for one or more development products.
Oversight of clinical operations team in the identification of potential challenges or risks with clinical study conduct and implementation mitigation plans.
Represents the Clinical Operations at the Product Team (PT), to discuss urgent operational questions and to provide strategic operational input to the PT.
Resolves and/or escalates issues raised by the clinical operations team or the SMT.
Takes a lead role in vendor selection, including critical review of contracts and negotiation of work orders.
Oversees CROs and other selected vendors on a product level including setting and monitoring key performance indicators and ensuring successful execution of program/studies.
Acts as the main escalation point of contact for strategic CRO partner(s) for the assigned program and for the key stakeholders in clinical operations.
Ensures consistency between studies for one or more products.
Provides input and clinical operations perspective on clinical trial design.
Authors, provides input and/or oversees program level and study level documents to support clinical studies and regulatory submissions.
Oversees financial aspects of assigned clinical study(ies) including preparing departmental level operating plans and ensuring adherence to planned study budgets.
Provides direction for strategic initiatives/oversees implementation of those initiatives for process and operational improvements.
Oversees/co-leads inspection readiness activities and acts as subject matter expert during regulatory inspections.
Works closely with Quality Assurance on SOP development.

QUALIFICATIONS

Education/Experience:

Advanced Degree in Scientific/healthcare field preferred.
Significant experience (10+ years) of clinical research and organizational management within the pharmaceutical industry (Biotech/small pharma experience preferred).
Global clinical trial research experience.
Experience leading cross functional teams.
Experience in rare disease and/or liver disease is preferred.

Knowledge, Skills and Abilities:

Demonstrated ability to present complex information to management, vendors and external audiences.
Demonstrated ability to create and manage one or more program budgets including communication of overspend/underspend
Ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
Strong attention to detail and the ability to establish priorities for team.
Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones.
Ability to work independently, take initiative, complete tasks to deadlines and support Clinical operations team in doing the same.
Demonstrated ability to lead, motivate and mentor staff and teams.
Excellent written and oral communication skills.
Displays a high level of professionalism with internal and external stakeholders.
Proven ability to remove barriers to success.
Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
Previous line management or direct management of team members.
Strong knowledge of applicable computer and project management software packages.
Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP).

The salary range for this position is $233,000 to $243,000 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.

Create a Job Alert

Interested in building your career at Mirum Pharmaceuticals? Get future opportunities sent straight to your email.

First Name

Last Name

Phone

Location (City)

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

School

Select...

Degree

Select...

Discipline

Select...

Start date year

End date year

Website

LinkedIn Profile

Are you within a commutable distance to Foster City and willing to commit to a hybrid work schedule with being on site minimum 2 days per week?

Select...

If you are not local to the Foster City area, are you willing to relocate?

Select...

Are you currently authorized to work for any employer in the US without visa support?

Select...

By participating in job interviews, you agree to treat all information shared regarding Mirum’s commercial performance, clinical and scientific data, sensitive corporate information, or any information that would reasonably be deemed (or is explicated noted) as confidential, including discussions and physical renderings/documentations, whether verbal or written as confidential. You are expressly prohibited from disclosing any interview information to third parties or other entities without Mirum’s express written consent. Breach of confidentiality may lead to legal ramifications at the determination of Mirum, termination of your application, or termination of employment if an offer is extended. Do you agree?

Select...

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.

How would you describe your gender identity? (mark all that apply)

Select...

How would you describe your racial/ethnic background? (mark all that apply)

Select...

How would you describe your sexual orientation? (mark all that apply)

Select...

Do you identify as transgender? (select one)

Select...

Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning? (select one)

Select...

Are you a veteran or active member of the United States Armed Forces? (select one)

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Mirum Pharmaceuticals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Select...

Are you Hispanic/Latino?

Select...

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Director, Clinical Operations

Apply for this job

U.S. Standard Demographic Questions

Voluntary Self-Identification

Voluntary Self-Identification of Disability