MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. 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. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.

 

POSITION SUMMARY 

The Associate Director, Clinical Development will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, 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. Participation in health authority meetings and regulatory filing activities are also part of this role. The Associate Director, Clinical Development operates in collaboration with other functions including internal Safety 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 medical monitoring of efficacy and safety data received from the clinical trials.
  • Responsible for the clinical aspects of data review and the Data Review Plan.
  • Supports preparation of clinical summaries for drug applications.
  • Supports preparation of scientific/medical questions from regulatory agencies.
  • Leading development of clinical development plan including clinical study design and protocol development.
  • 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:

  • MD or Bachelor’s Degree or advanced degree in a life sciences discipline.
  • If not MD, PhD preferred.
  • 5 years of experience in the pharmaceutical industry (Clinical Development) preferred.
  • Experience in clinical trials with multidisciplinary trial teams.
  • Experience in fully outsourced CRO models.
  • 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:

  • Demonstrates excellent scientific writing skills.
  • Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret and report data effectively.
  • Strong experience in clinical data review and interpretation.
  • In-depth knowledge of drug development processes.
  • Strong verbal and written communication.

#LI-Onsite

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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