- Provide support for clinical development colleagues, Investigators, study site teams, and institutional administrative teams conducting and/or overseeing clinical trials and offer problem solving, operational insights and scientific support for this important group of stakeholders.
- Build strong relationships and support clinical trial logistics with investigators, study teams and institutional stakeholders leading to timely site activation and study subject recruitment.
- Identify barriers to site activation and/or patient recruitment, and discuss options/solutions with Investigators, study site teams, and institutional administrative team members to address and remove these barriers.
- Escalate site feedback or concerns to project teams related to the company's development program.
- Develop a robust understanding of clinical practice, site operations, and institutional administrative practices associated with gene editing therapies.
- Ensure investigators and institutional stakeholders are knowledgeable about investigational therapies and disease management to support an efficient multidisciplinary care model.
- Identify key interfaces and cultivate relationships with key stakeholders at each institution center of excellence (COE).
- Facilitate the establishment of referral networks between trial sites and surrounding institutional stakeholders and healthcare systems.
- Develop and execute trial site- specific engagement plans to optimize enrollment and operations based on healthcare system insights. Customize strategies for potential study subject identification, access, and recruitment.
- Collect information on patient experiences and needs based on feedback from Investigators and their study site teams.
- Gather site-specific insights and generate high- value reporting on patient diagnosis, referral patterns, and logistical treatment challenges.
- Coordinate and support educational activities as requested.
- Educate on CRISPR/CAS9 technology. Identify gaps/ needs.
- Educate on diseases under study, and emerging operational approaches to disease management.
- Educate on gene editing clinical trial participation (site use of approved materials for educating potential subjects and their families).
- Doctorate Level Degree (Pharm.
- Extensive clinical (patient care) and/or clinical trial experience in cardiology or genetic medicine.
- Prior Pharmaceutical or Device industry experience as a MSL or Clinical Trial Liaison giving the candidates a solid understanding of scientific exchange in the context of compliance/ regulated environment and robust experience supporting execution of clinical trials.
- New product launch experience preferred.
- Ability to critically assess situations to prioritize the importance, urgency and risks, and present leadership with recommendations.
- Organized, able to multi-task to meet timelines in a fast-paced environment with strong attention to accuracy and detail.
- Excellent presentation, communication, and project management skills across a variety of interaction mediums including in person, digital, email, phone, etc.
- Ability to understand and clearly and effectively communicate complex scientific and medical information to both internal and external stakeholders.
- Established track record of effective and influential oral presentations to both large and small audiences within the healthcare profession.
- Willingness and ability to travel 50-70% including overnight stays.
- Ability to manage a geographically assigned territory from a home-based office.
- Computer skills including Excel, Word, Power Point, Outlook, and programs such as Zoom are expected.
- Valid driver's license
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Regional Scientific Director, Gene Therapy/Cardiovascular - Dallas, United States - The Medical Affairs Company
Description
Regional Scientific Director, Gene Therapy/Cardiovascular (West)
The Medical Affairs Company (TMAC) is building a global field medical team initially comprised of US-based Regional Scientific Directors (RSDs) and European-based RSD on behalf of one its clients which is developing revolutionary gene-editing therapies with CRISPR-based technology.
The company's in vivo programs use CRISPR to enable precise editing of disease-causing genes directly inside the human body and its ex vivo programs use CRISPR to engineer human cells outside the body for the treatment of cancer and autoimmune diseases.
The RSDs will set the standard for a new class of medicine and educate PIs, Centers of Excellence, KOLs and institutional healthcare disciplinary teams thus optimally enabling them to harness the full potential of the company's CRISPR-based, first-in-class gene editing platform and delivery technologies.
The RSDs will primarily support the company's global pivotal leading Phase 3 trial being evaluated for the efficacy and safety of patients with ATTR amyloidosis with cardiomyopathy.
The RSDs will focus their engagement efforts to targeted trial sites and their personnel providing the following:
Clinical Trial Awareness and Enrollment Focused Activities:
Qualifications:
D., M.D. or D.O.) and 5+ years industry or related field experience.
