POSITION SUMMARY Reporting to the Global Medical Affairs Lead, this individual will be responsible for internal and external scientific and clinical research initiatives under the Medical Affairs umbrella, supporting HDV and PSC/PBC (liver portfolio). This individual will also help develop the strategy, tactics, KOL engagement plan and disease state awareness activities for the adult hepatology programs. They will also help manage compassionate use and expanded use programs for the HDV and PSC/PBC programs.
The individual is a member of R&D and will provide scientific, clinical, and strategic feedback across all appropriate cross-functional teams.
JOB FUNCTIONS/RESPONSIBILITIES- Collaborates across all appropriate functional groups to support ongoing clinical trials, medical and scientific affairs research initiatives, and other scientific affairs activities for the adult hepatology program.
- Supports and drives scientific and clinical communications for internal and external stakeholders, including supporting advisory boards related to adult liver disease indications.
- Leverages expertise and relationships within adult hepatology and gastroenterology to support patient enrollment for the adult liver clinical research studies, while working closely with the clinical study leads, the CTLs and VP of Clinical Development.
- Identifies knowledge gaps for existing areas of interest for the program and develops strategy to mitigate these gaps utilizing internal resources as well as external scientific collaborations.
- Leads and collaborates across appropriate functional groups to execute compassionate use and expanded access programs for Brelovitug and Volixibat.
- Oversees both internal and external research activities and initiatives such as, but not limited to, natural history studies, collaborative forums, real world data registries, data mining for areas of interest for publication, and other ongoing and future research efforts.
- Leverage expertise in liver disease to support Safety and Regulatory teams.
- Leverages analytical skills in discovering data insights from clinical research data, including literary research of relevant clinical data.
- Support strategic publication planning and development and editing of conference abstracts, posters, presentations, and manuscripts to support programs, and execution of the strategic publication plan.
- Works closely with other members of the medical affairs infrastructure.
QUALIFICATIONSEducation/Experience: - Medical Doctor degree required.
- GI/Hepatology experience strongly preferred.
- Minimum of 3+ years industry experience with preference for prior HDV, PSC, and/or PBC experience.
- Experience with scientific publications, congress activities, research forums and other core scientific communications deliverables.
- Working with data generation, natural history registries and/or building real world registries is a plus.
Knowledge, Skills and Abilities: - Previous experience in clinical development and/or medical affairs, scientific research initiatives.
- Must be a strategic thinker with close attention to detail.
- Excellent collaboration skills to be able to work with other internal functions, external collaborators, authors/reviewers to obtain feedback and incorporate information into a final product.
- Outstanding oral and written communication skills, and ability to communicate complex scientific concepts in a compelling and concise manner to various internal and external stakeholders.
- Must have the ability to write scientific content, be resourceful, study literature, form opinions and create strategy with alignment from key stakeholders.
- Rare disease, liver or gastroenterology disease experience is a plus.
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