AngioSafe, Inc.

Job Summary

We are seeking a Director of Medical Affairs to lead key medical and clinical affairs activities across the department. Reporting to the Head of Regulatory, Clinical and Medical Affairs, this role leads the overall activities of Global Medical Affairs, including Evidence Generation, Scientific Exchange, and Publication activities. As part of the Core Teams, the role interacts with the key commercial, regulatory, clinical, R&D, and operations functions and Focuses on ensuring the scientific integrity and clinical value of AngioSafe’s products.

The role will identify and engage HCPs and patient advocacy groups through collaborative partnerships to enhance educational initiatives, advance the appropriate application of therapies that provide patient-centric outcomes, and advise the medical and clinical affairs department on matters of strategic importance, including clinical trials.

Responsibilities (Specific tasks, duties, essential functions of the job)

Lead business and operational planning across key medical activities including Medical Information, Medical Communications and Publication planning, and Grants and Medical Education. Lead the planning and operations of the Santreva Podium & Publication (PnP) Committee, aligning cross-functional teams to deliver high-impact scientific projects. Champion Investigator-Initiated Studies (IIS) by aligning research priorities with business strategy, partnering with investigators, and contributing to study designs, abstracts, and manuscripts. Create compelling presentations and reports for senior leadership that translate complex data into actionable insights. Collaborate with internal and external stakeholders to develop and execute a robust evidence generation roadmap (pre-and post-market) that supports the overall Santreva business strategy. Foster scientific collaboration by building and nurturing relationships with leading physicians, researchers, and thought leaders to advance shared goals in cardiovascular disease. Elevate scientific presence by monitoring competitive activity, anticipating key data releases, and ensuring strategic visibility at global congresses and podiums. Develop as needed and support a network of scientific experts and medical key opinion leaders, and other stakeholders in the cardiovascular field, academic institutions, and healthcare organizations. Ensure that physicians have accurate and up-to-date information about AngioSafe products and therapeutic area. Furthermore, the individual will provide product and pipeline therapeutic area expertise to address KOL and HCP inquiries. Collaborate with cross-functional teams, including R&D, Clinical Operations, Marketing, and Sales, to ensure alignment and integration of medical affairs activities and support launch, reimbursement, and product development activities. Respond to unsolicited inquiries from healthcare professionals regarding our products, clinical trials, therapeutic area, and medical literature. Provide scientific and clinical insights to support the development and execution of clinical trials, publications, and medical education programs. Serve as the focal point for medical know-how by regularly reviewing clinical articles and attending scientific/medical meetings, advisory boards, and conferences to both internal and external stakeholders. Design and implement clinical training curriculums by assessing and analyzing organizational, HCP, and patient advocacy requirements, obtaining educational content through participation in cross-functional teams, congresses, forums, and meetings. Work closely with the sales organization to support team’s ability to understand clinical information and identify insights based on their field experience. Ensure robust compliance related to regulations on training, education, and HCP interactions are followed. Perform various assigned duties as needed based on evolving needs of the department.

Knowledge, Skills, and Abilities

Strategic thinker with a strong focus on education, adherence to compliance guidelines, and operational efficiency. Ability to interpret scientific data, be current on clinical competitive landscape, and have strong scientific writing skills. Strong knowledge and understanding of FDA regulations, GCP, and ISO 14155, specific to medical devices. Must possess excellent verbal and written communication skills and work effectively in a demanding, fast-paced environment. Excellent organizational, relationship-building skills, and leadership skills, capable of motivating a matrix team and managing multiple projects. Detail-oriented with strong problem-solving skills and ability to adapt to work collaboratively with different cross-functional teams at a global level. Promote a culture of integrity, transparency, and ethical behavior within the organization. Ability to develop and execute clinical study protocols, specifically in the area of cardiovascular care. Ability to manage conflict, drive consensus, and promote decision-making. Anticipates business and industry issues; recommends relevant process improvements. Sees the broader picture and longer-term impact on company.

Qualifications (Experience and Education)

Advanced degree (MD, PhD, or PharmD) in a relevant scientific discipline. Preferable experience in the vascular space (Cardiovascular and Peripheral) Minimum 8+ years of experience in Medical Affairs within life sciences, catheters preferred Extensive knowledge of the interventional cardiovascular area, including current treatment paradigms, clinical trials, and emerging trends (Preferred). Advanced knowledge/proficiency with dashboard management, tracking and reporting on functional deliverables, and compliance tracking, required. Proven track record of building and maintaining relationships with KOLs and other key stakeholders. Experience developing and maintaining relationships with physician customers and field reps. Experience with the development of educational content and delivering systematic training. Clinical research experience in medical devices, biologics, or drugs is strongly preferred. Experience in support of global regulatory submissions for medical devices is strongly preferred. Excellent communication and presentation skills, with the ability to effectively communicate scientific and medical information to diverse audiences. Ability to work independently and collaboratively in a fast-paced, dynamic environment. Advanced proficiency with Excel, Word, PowerPoint, Outlook, NCBI, Clinicaltrials.gov, FDA platforms. A combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Principals only Please

Company Information

AngioSafe is committed to a diverse workplace and is committed to equal opportunity employment for all job applicants without regard to race, color, religion, sex, sexual orientation, age, gender, gender identity or expression, size, national origin, disability, or veteran status. AngioSafe complies with all applicable local, state, and national laws governing non-discrimination in employment. AngioSafe will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager.