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DEPARTMENT: Medical Affairs
LOCATION: Fully Remote – frequent travel to the Midwest (Chicago, MN, Michigan, Milwaukee, etc…)
COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte ’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte ’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte ’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www. Humacyte .com.
JOB DESCRIPTION:
Humacyte , Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.
POSITION BACKGROUND:
This position acts as a bridge between Humacyte , KOLs, physicians, scientists, patient societies, CROs and other groups and provides scientific and clinically sound information about Humacyte products. This is an external facing position that interfaces with the medical community, key opinion leaders and regulatory agencies as applicable. Strong clinical expertise, communication and influencing skills are paramount for success in this position.
MAJOR ACCOUNTABILITIES:
Utilizing a strong understanding of Humacyte products and our core therapeutic areas, engage external stakeholders and communicate the benefits of our products to their applicable patients.
Develop a network of Key Opinion Leaders (KOL) and KOL engagement strategies by collecting insights and medical/scientific data.
Execute territory plans in alignment with Medical Affairs plans.
Identify and communicate key clinical and research issues and insights from KOLs to appropriate departments.
Collaborate with clinical team in identifying clinical investigators and partner with Clinical team to educate investigators and sites through communication of relevant medical/scientific data.
Serve as a subject matter expert for internal cross-functional teams, as it relates to the medical/scientific data for our products.
Serve as a subject matter expert for regional external meetings, as it relates to the medical/scientific data for Humacyte products, in a fair and balanced manner.
Provide scientific support and participate in medical education for healthcare professionals (HCPs) through on-site presentations at healthcare institutions, investigator meetings, national conferences, advisory boards, or regional meetings.
Collaborate in the development of educational materials for delivery at conferences, KOL engagement activities, and other speaking engagements.
Partner with the internal stakeholder teams to develop medical/scientific materials that meet regulatory guidelines and provide key medical/scientific data to desired audience.
Review for technical/medical/scientific accuracy written or electronic materials related to Humacyte products to ensure accuracy and compliance to regulatory requirements including, but not limited to, clinical trial protocols, study tools and clinical study reports (CSR)
Utilize clinical expertise to:
assist with Safety operations, reporting and exposure tracking. collaborate with personnel on Health Economics projects. assist with Regulatory Affairs operations and discussions.
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.
Provide detailed reports of interactions with external stakeholders.
Keep abreast of the latest research and developments in the medical/scientific fields related to our product and indications,
Other duties as assigned
SPECIAL COMPETENCIES:
Outstanding and demonstrated 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
GENERAL COMPETENCIES:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Willingness to travel within assigned region, this may include frequent air travel
QUALIFICATIONS:
MD/DO, PhD, DMSc, or NP/PA degree required.
Preferably Midwest-based, as the territory covered will include frequent travel to Chicago, MN, Milwaukee, Michigan and other nearby states Willingness to travel – 50%+ A minimum of 2 years of experience in a Medical Science Liaison or equivalent position required Experience in vascular surgery, surgery, regenerative medicine, nephrology and/or cardiovascular medicine is preferred.
MSL-BC is a plus
COMPENSATION & BENEFITS HIGHLIGHTS:
Stock Options
401k Plan with 4% Match and no Vesting Schedule
Medical, Vision and Dental Plans
Company Paid Long Term/Short Term Disability
Company Paid Life Insurance
23 Days Paid Time Off (PTO)
10 Company Designated Holidays + 2 Floating Holidays
Paid Parental Leave Policies
* Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3 rd party firms and/or agency recruiters. **
The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.