Associate Director, Medical Affairs & Project Management

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.

POSITION SUMMARY

Responsible for supporting all of the medical affairs activities including project management, organizing scientific advisory boards, KOL engagement, publications and planning, and planning and executing scientific and medical education.

JOB FUNCTIONS/RESPONSIBILITIES

  • Project Management by ensuring Medical Affairs initiatives and tactics are executed within agreed upon timeline and budget.
  • Organize scientific advisory boards and investigator meetings including operational planning for advisory boards (contracting with advisors, approving FMV honoraria, securing venue, travel, accommodations), content development and speaker preparation.
  • Plan and execute congress related activities: session planning, KOL engagement, advocacy engagement, pre and post congress debriefs, daily debriefs, congress summary and educational and scientific booth activities.
  • Publication planning and operations: Critically working with internal and external stakeholders on publications including abstracts/manuscripts, and publication plan. Interactions would include but not limited to, vendor management, internal/external authors, biostatistics, clinical, scientific. A focus on tracking timelines and submissions is required.
  • Ability to edit and/or contribute to clinical and scientific content is a plus.
  • Plan and execute scientific/medical education (non-CME) such as: scientific symposia at congresses, web-based medical education, along with the development of MSL materials (reactive and proactive).
  • Working with/supporting the Head of Medical Affairs on all medical affairs related activities, as well as with the Mirum leadership team (providing project tracker or status updates as needed).
  • Supporting commercial on various tactics (e.g. Brand Plan and commercial materials).

QUALIFICATIONS

Education/Experience:

  • Bachelor’s, Master’s, or Doctorate (i.e. RN, BS/BA, MS/MA, PharmD) level of degree from an accredited university/program.
  • Individual’s with project management and operations experience are preferred.
  • 5+ years of biopharmaceutical experience, with an understanding of the current regulatory and compliance environment for pre-launch and post-launch initiatives for an investigational asset.

Knowledge, Skills and Abilities:

  • Proficient in Microsoft OneNote, Teams and Office 365 (proficiency with Microsoft PowerPoint and Excel is essential).
  • Highly organized individual, who possesses the ability to work in a fast-paced agile environment.
  • Ability to interact externally and internally to support global business strategy across assets and launches.
  • Must possess excellent oral and written communication skills.
  • Ability to interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, statistics, regulatory, publications, chemistry, manufacturing, controls ‘CMC’ etc.) as they relate to on-going medical affairs projects.
  • Represents or Mirum at external meetings including investigator meetings, scientific congresses, regulatory meetings, along with advisory boards etc.
  • Ability to work independently with some supervision and guidance.
  • Exercises sound judgment within well-defined practices and policies.
  • Ability to manage budget for assigned projects.
  • Familiar with ICJME authorship criteria.
  • Clinical experience/research background or knowledge in one of following areas: liver diseases, pediatrics/neonatal care, cholestasis or rare diseases is preferred.

Work Environment:

  • 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 30% of work time.
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