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 were 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 Medical Director will join the Clinical Development group and will be responsible for clinical trial development-related activities in a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to clinical development plans, input into product development plans, protocol development, support of study startup, oversight of trial execution, recruitment, closeout, data analysis and supporting presentation of study data at scientific meetings, as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis, are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Medical Director operates in collaboration with other functions including internal Safety and Clinical Operations teams.
JOB FUNCTIONS
- Leadership and management of all aspects of complex, global development clinical study program(s), from phase 1 through regulatory approval(s).
- Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy.
- Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.
- Support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, etc.)
- Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
- Responsible for medical monitoring of efficacy and safety clinical trial data.
- Strategic input on the overall development plan, internal and external evaluation of new indications and studies.
- Oversight of medical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials
- Collaboration in the analysis and writing of scientific publications/presentations.
- Works closely with other functions, in particular with Safety function and Clinical Operations.
- Co-leads Study Management Team with Clinical Operations lead.
QUALIFICATIONS
Education/Experience:
- MD, with a minimum of 5 years.
- Experience in immunologic diseases, hepatic diseases, and/or rare disease highly desirable.
- Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.
Knowledge, Skills and Abilities:
- Demonstrated accountability for delivery on complex development plans.
- Leadership in clinical development programs and multidisciplinary trial teams.
- Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
- Ability to understand and communicate risks, as well as develop and execute contingency plans.
- Experience presenting data to regulatory agencies and advisory committees.
- Ability to think creatively and develop and execute in a fast-paced environment.
- Detail oriented with exceptional organizational skills.
- Effective communicator with strong verbal and written skills.
- Ability to identify issues, analyze situations and provide effective solutions.
- Solid understanding of the clinical development process.
- Knowledge of applicable regulatory requirements.
- Willingness and ability to travel domestically and internationally is required; it is anticipated that this will be 30% of work time.
#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, veterans 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.
Apply for this job
*
indicates a required field
First Name *
Last Name *
Email *
Phone *
Location (City) *
Resume/CV *
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
Education
School * Select...
Degree * Select...
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 Mirums 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 Mirums 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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Mirum Pharmaceuticalss Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis 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.
Select...
Voluntary Self-Identification of Disability
Form CC-305
Page 1 of 1
OMB Control Number 125