Associate Director, Clinical Development

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 Associate Director, Clinical Development will be responsible for supporting clinical trial related activities for Brelovitug, a key asset in Phase 3, on a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to drafting key clinical trial and program-level documents, protocol development, support study startup, recruitment, ongoing clinical development management, and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis are required. The Associate Director, Clinical Development operates in collaboration with other functions including internal Safety, Regulatory, Biometrics, and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES

Responsible for drafting key clinical trial and program-level documents in collaboration with Clinical Operations, Biostats, Medical Writing and the CROs

Responsible for clinical aspects of study startup, execution and close-out in close collaboration with Clinical Operations, Data Management and CRO

Supports the monitoring of efficacy and safety data received from the clinical trials

Supports preparation of clinical summaries for drug applications

Supports preparation of scientific/medical questions from regulatory agencies

Support the analysis and drafting of clinical trial and scientific publications

Supports the planning, conduct and follow-up of external clinical development- or study-related meetings

Responsible for clinical aspects of the TMF

Support the running and operational aspects of the Clinical Development team including meeting support, inspection readiness and organizational support

QUALIFICATIONS

Education /Experience:

Bachelor’s Degree and/or advanced degree in a scientific discipline.

PhD or PharmD preferred

3+ years of experience in the pharmaceutical industry, including 2+ years in Clinical Development teams.

Manage several clinical trials with multidisciplinary trial teams

Experience in working with CROs

Medical/scientific expertise appropriate to clinical program

Demonstrates ability to establish strong scientific partnership with key investigators

Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process

Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.

Knowledge, Skills and Abilities:

Demonstrated accountability for delivery on clinical studies.

Demonstrates excellent scientific writing skills.

Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.

Strong experience in clinical data review and interpretation.

Ability to 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.

#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.