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.
The Senior/Executive Director, EU Medical Affairs will provide expert medical/scientific strategic and operational input into core medical affairs activities such as health-care professional/provider interactions (Payers, Prescribers, Providers), generation of clinical and scientific data (enhancing therapeutic benefit, value and filling data gaps), educational initiatives (medical education, collection of real-world data, guidelines and value proposition), safeguarding patient safety (risk minimization activities / safety surveillance activities). The Medical Director will work closely with marketing and sales to provide strategic medical input into brand strategies and will support medical/marketing activities (promotional material generation/product launches) and market access. Additionally, he/she will provide scientific and technical support for assigned products; deliver scientific presentations; develop and maintain professional and credible relationships with, key opinion leaders, actively participate in relevant Brand Teams and Launch Readiness Reviews, help develop medical affairs strategies and tactical deliverables for assigned products, develop innovative research concepts for clinical data generation and provide relevant scientific and technical training.
- Initiate medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
- Participate in design and execution of clinical trial safety, product safety and risk management plans.
- May also carry responsibility for routine and ad-hoc safety monitoring reports to regulatory agencies.
- May review, assess and report applicable Adverse Events and Serious Adverse Events if assigned by Mirum conduct on clinical studies.
- May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (e.g. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
- Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to cholestatic liver disease, including disease specific information.
- Keep abreast of professional information and technology through conferences and/or medical literature and act as a therapeutic area resource.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
- Serve as the scientific team interface for key regulatory discussions.
- May assist in the development of scientifically accurate marketing materials, medical education programs, scientific advisories, and educational symposia.
- Assist with the scientific review, development, approval, execution and communication of medical affairs sponsored or supported clinical research activities.
- Ensure budgets, timelines, compliance requirements are factored into programs and medical affairs activities.
- Can address complex problems within discipline/project or across disciplines.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.
- Supervisory role over EU MSLs and potentially Medical Advisors.
- Works independently with limited guidance.
- Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
- If, non-MD, doctorate prepared individual (PhD, PharmD).
- 10+ years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent, and global experience is preferred.
- Proven leadership skills in a cross-functional global team environment.
- Expert knowledge in a relevant therapeutic specialty (Hepatology, GI or rare diseases).
- Ability to interact externally and internally to support global business strategy.
- Ability to run a clinical study or medical affairs team independently with little supervision.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Must possess excellent oral and written English communication skills.
- At least one further major international language is preferred.
KNOWLEDGE, SKILLS, AND ABILITIES
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the ‘essence’ and can change the course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
To apply, please send your resume to email@example.com.