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
Senior Director of Data Management is responsible for the strategic planning and oversight of the Data Management function comprised of internal and external data management professionals and data management supporting groups within biometrics and cross-functionally from safety, clinical development, and clinical operations. Participates in developing innovative ideas and testing new processes and systems for the management of clinical data.
Responsibilities:
Provide clinical data management leadership, expertise, and guidance for strategic optimized planning of clinical development in accordance with corporate objectives.
Provide leadership and technical data management input. Represent and communicate data management activities, progress, and risks to cross- functional leads and senior management team.
Lead efforts to establish a data-driven culture support improving business efficiencies.
bolstering use of data, reporting and analytics.
Identify, plan, and drive strategic initiatives, policies, implementation and adherence to data manager standards and processes.
Develop SOPs, training, work processes and standards for data management activities and refine existing processes related to data management.
Qualifications:
Bachelor’s degree in clinical, biological, mathematical sciences or related field is required; an advanced degree is a plus; equivalent experience may be accepted in lieu of the degree requirement.
Minimum 12 years of clinical data management experience in biotechnology or pharmaceutical industry.
Minimum 10 years of Electronic Data Capture (EDC) experience; IXRS development.
Must have strong knowledge of ICH and GCP and Data Management processes and systems.
Solid understanding of clinical drug development processes and agency filing experience.
Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment.
#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.