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Role Summary
This position acts as a bridge between Humacyte and internal/external scientific stakeholders and other applicable stakeholders; and provides scientific and clinically sound information about Humacyte products. This is an external facing position that interfaces with the medical & scientific community, key opinion leaders, and regulatory agencies as applicable. Strong clinical expertise, communication and influencing skills are paramount for success in this position.
Responsibilities
- Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives for the assigned territory.
- Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/ Key Decision Makers/investigators and the company's Medical Affairs and development groups.
- Develop a network of KOLs and KOL engagement strategies for the assigned territory.
- Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs and management teams.
- Serve as a subject matter expert for internal cross-functional teams as it relates to the medical/scientific data for our products.
- Develop educational materials for delivery at conferences, KOL engagement activities, trainings, and other speaking engagements.
- Lead role in educational/scientific activities, such as advisory boards, KOL meetings, conference presentations, trainings, and other activities as delegated by leadership.
- Support speaker training, as requested, and ensure the speakers are updated on new data.
- Collaborate with clinical operations team in identifying clinical investigators and partner to educate/train investigators and sites through communication of relevant medical/scientific data.
- Work with CRO clinical research associates (CRAs) to ensure that investigators and site staff have a thorough understanding of the investigational product, protocol eligibility criteria, and all study procedures.
- Arrange and/or conduct educational programs to increase awareness about the product and itβΓΓ΄s handling and clinical trial enrollment.
- Function as a key interface and resource for investigators while respecting the roles of CRO personnel.
- Review for technical/medical/scientific accuracy written or electronic materials related to our products to ensure accuracy and compliance to regulatory requirements including, but not limited to, commercial tools, clinical study tools, and other stakeholder-facing materials, when required.
- Utilize clinical expertise to:
be the first point of contact for Medical Information requests.
assist with Safety operations, reporting and exposure tracking.
collaborate with personnel on Health Economics projects.
respond to unsolicited/off-label requests from KOLs and/or prescribers who work with commercial teams.
assist with Regulatory Affairs operations and discussions.
Keep abreast of the latest research and developments in the medical/scientific fields related to HumacyteβΓΓ΄s products and indications.
- Other duties as assigned.
Qualifications
- MD/DO with relevant experience in Regenerative Medicine and/or surgery strongly preferred with a minimum of 5 years of MSL and/or medical education/training experience in biotech/pharma will be considered.
- Clinical trial development and drug/device launch experience is strongly preferred.
- MSL-BC strongly desired
- Outstanding and demonstrated scientific communication and influencing skills.
- Demonstrated ability to develop strong relationships with individuals at all levels.
- Outstanding presentation and training skills.
- Demonstrated expertise in developing training tools appropriate for high-level stakeholders in the scientific and/or medical communities.
- Demonstrated ability to work independently and not requiring close supervision while adhering to Medical Affairs strategic direction.
- Excellent communication and interpersonal skills.
Skills
- Scientific communication
- KOL engagement
- Medical information handling
- Educational program development
- Cross-functional collaboration
- Regulatory and compliance awareness
Education
- MD/DO required (or equivalent)