Medical Director, Medical Affairs - United States
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- The Medical Director, Medical Affairs, will be primarily responsible for developing the medical strategy and medical plan as well as executing against the medical plan in support of our company’s marketed cholestasis product/indication.
- This will require a close working partnership with colleagues in medical affairs (global, US and international as appropriate) including US Medical Science Liaisons, global Publications and Scientific Communications, global Health Outcomes Research, global Medical Information, Investigator Initiated Research, Thought Leader engagement, and Congress/Advisory Board operations.
- The Medical Director, Medical Affairs will also be required to work closely with cross-functional colleagues in US commercial, global pharmacovigilance, clinical development, patient advocacy and corporate communications.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Drive the development of an aligned medical plan for our company's marketed product in cholestasis , as well as other cholestasis indications.
- Develop and execute specific tactics/projects in support of PBC; including data generation tactics, study ideas and execution, and budget development and management.
- Develop and run a PBC medical affairs / clinical development data generation and dissemination working group.
- Work with global Publication and Scientific Communication team to develop and execute aligned strategies/tactics for maximizing our scientific communication efforts.
- Primary point of Medical contact with US commercial, working to provide appropriate medical input into the development of promotional pieces, support in-market launch activities, contribute strategic medical input as required to the development of brand strategies, support the business insights team with market research projects, and collaborate with the US MSLs to support the payer focused activities.
- Work with the global HOR team to provide medical input into real world evidence generation projects, including comparative effectiveness/value for money projects.
- Primary point of Medical contact with the global Patient Advocacy team ensuring appropriate medical support is provided to all patient education efforts.
- Work with the Investigator Initiated Research (IIR) team to provide appropriate medical review to concept/protocol reviews in PBC.
- Serve as content expert in PBC and master the data in support of our company’s product value.
- Support interactions with thought leaders and our advocacy partners (professional and patient organizations) including scientific collaborations, speaker training, advisory boards, and regional/national/international conferences.
- Contribute to, and support execution of the lifecycle management activities in PBC and other cholestasis indications as required.
- Stay up-to-date on new data and developments in the field, and key publications of interest.
- MD/DO/PhD/PharmD with a minimum of 5 years of bio-pharmaceutical industry experience in Clinical Research and/or Medical Affairs.
- Other biomedical degrees (NP, PA, RPharm) with a minimum of 10 years of bio-pharmaceutical industry experience in Clinical Research and/or Medical Affairs.
- An MPH in chronic disease epidemiology/biostatistics in addition to any of the above degrees will be a strong plus.
- Prior experience in Hepatology, Gastroenterology, Immunology preferred.
- Direct experience developing and executing research (interventional or observational) studies required.
- Demonstrated track record of publishing in peer-reviewed scientific journals required.
- Launch experience strongly preferred.
- Strong understanding of drug development and commercialization process.