Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
The Medical Director/Sr. Medical Director will join the Clinical Development group and support Clinical Science deliverables for clinical trials and programs associated with the clinical development of molecules in the stages of clinical development. The optimal candidate will have the desire to proactively participate within a cross-functional team of internal clinical, regulatory, scientific, operational and commercial colleagues and have the ability to interact with external experts, investigators and government agencies. This role is instrumental in supporting the growth of Mirum’s pipeline in rare liver diseases. The successful candidate will have hands-on responsibility designing clinical trials, publication planning, and participating in health authority interaction activities to support NDA submissions. Will serve as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in close collaboration with the clinical operations team. As the medical lead of a study, you will be responsible for ensuring data quality, summary and writing of clinical study reports in close collaboration with the clinical operations, biometrics and medical writing team.
- Leadership and management of all aspects of complex, global development programs, including those focused on multiple indications, from phase 1 through post-commercialization.
- Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory/manufacturing 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.
- In conjunction with SVP Clinical Development, support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, Steering Committee Meetings, etc.
- Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
- Conduct literature searches, draft background sections, and ensure that standardized disease/molecule specific language in incorporated (i.e. eligibility and dose modification criteria).
- Evaluate medical rational in new indications, discuss possible proof-of-concept and registration trial designs with external experts.
- MD, with a minimum of 2 years or a PhD or PharmD with a minimum 5 years of comprehensive drug development experience.
- Experience in Liver diseases preferred.
- Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.
KNOWLEDGE, SKILLS & ABILITIES
- Demonstrated accountability for delivery on complex development plans.
- Experience working on cross-functional team.
- 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.
- This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
- Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 20% of work time.
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time position.
- Compensation: Competitive and commensurate with experience; includes equity package.
- Benefits: Medical, dental, and vision, and more.
Please submit your resume to firstname.lastname@example.org