Associate Director, Post Marketing Study Management

Job content

MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver 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 liver 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:Postion SummaryThe role will be responsible for the overall management and coordination of operational activities involved in the planning, conduct and completion of post-marketing clinical studies including non-interventional/observational studies, registries, compassionate use programs, Investigator Initiated Studies, and outcomes research. This includes the management of deliverables, adherence to budget, and ongoing risk mitigation. In conjunction with the medical and scientific teams, this role manages selected vendors, assigned internal team members, and collaborating physicians to support the generation of post-approval data, real world evidence, and answers to medical/scientific questions about Mirum’s products.Job Functions/Responsibilities

• Leads operations for post-marketing studies from idea generation to report
• In cooperation with the medical and regulatory teams, processes data generation requests from relevant regulatory authorities and internal stakeholders and implements them in a post-marketing protocol.
• Leads, interacts, collaborates and integrates processes with functional counterparts within Medical Affairs, Clinical Development, Supply Chain, and Regulatory to activate post-market studies in compliance with regulations and relevant SOPs.
• Assists the scientific staff in developing and reviewing protocols, informed consent forms, study reports and other scientific documents related to the post-marketing program.
• Drives data generation programs, in close cooperation with Global Medical Affairs and other internal stakeholders by overseeing and coordinating the establishment of a study management team, publication support, filing, milestones and budgets.
• Liaises with global departments to ensure all post-marketing studies are appropriately tracked, coordinates the ongoing tracking and ensures data is easily available in a dashboard/Sharepoint.
• Manages project/program reviews and meetings.
• Supports Global Medical Affairs in the development of registry partnerships.
• Assists the scientific staff in assessing natural history databases and cohort databases for relevant indications.
• Assists with regulatory submission preparations related to the post-market program.
• Authors/oversees the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics, and reporting to regulatory authorities.
• Identifies, evaluates, and selects external vendors. Trains vendors and stakeholders and manages activities to ensure the quality meets Mirum and regulatory requirements.
• Performs periodic visits to sites and/or vendors to assess progress of studies. Oversees the identification, selection and proper initiation of sites.
• Oversees development of CRFs, and databases to ensure adequate data collection for studies and outcomes research.
• Facilitates the compassionate use program(s) including receiving requests, leading the compassionate use committee and communicating with physicians regarding the committee decisions.
• Manages the expanded access program through oversight of vendor(s) including ensuring appropriate patient inclusion, adequate drug supply planning and data collection.
• Provides operational expertise and support for Investigator Initiated Studies (IIS) with functional area oversight to ensure quality of work, adequate drug supply planning and compliance with regulatory requirements.
• With Medical and Safety, assesses trends in data including adverse events, drug compliance, etc.
• Oversees timeliness of data collection. Participates in data review meetings. Oversees maintenance of files and the archival process.
• Ensures adherence to SOPs, Good Clinical Practice and ICH regulations.

QualificationsEducation/Experience:

• Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired.
• At least 5 years’ experience as a global study management.
• Experience in post-marketing studies.
• Experience in rare disease or hepatology preferred.
• Experience working in a fully outsourced model
• Demonstrated experience coordinating interdepartmental activities and efforts to meet program goals.
• Expert and extensive knowledge of post-marketing requirements, vendor management and global study operations.

Knowledge, Skills And Abilities

• Must have a demonstrated working knowledge of GCP, ICH guidelines, and regulations.
• Ability to deal with multiple priorities with aggressive timelines.
• Possesses exceptional communication skills, both oral and written with the ability to influence internal and external stakeholders.
• Strong social skills to build relationships with Investigators and site staff
• Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/elevate problems in a timely manner.
• Ability to find creative solutions to issues impacting timelines and budgets.
• Epidemiological experience from conducting registry/database studies including methodological and technical expertise
• Understanding of product life cycle process from early development to post-launch to deliver key evidence needs for different stakeholders
• Strong customer focus.
• Experience managing post-marketing studies, compassionate use programs and Investigator Initiated studies.

Work Environment

• This is a high growth, fast paced small organization. The ability to be productive and successful in such work environment is critical.
• Willingness and ability to travel domestically and internationally is required, including ability to travel overnight and infrequently on weekends for congresses/meetings. It is anticipated that travel will be up to 10% of work time.

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.

• For US Applicants Only: Mirum Pharmaceuticals is also committed to the safety and wellbeing of all who work with us. As we continue to monitor the COVID-19 pandemic, Mirum Pharmaceuticals has made the decision to require all perspective candidates and independent contractors in the United States to be fully vaccinated against the COVID-19 virus. To be considered fully vaccinated is to have both doses of a two-dose vaccine two weeks apart or two weeks since a single-dose vaccine has been administered. This does not apply to candidates/independent contractors who are granted an accommodation/exemption by Mirum Pharmaceuticals based on qualifying religious or medical reasons.