Medical Affairs Director

Full Time

Victor, NY, Victor, NY, US

LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.

We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient.

POSITION TITLE: Medical Affairs Director

SHIFT HOURS: 8:00am to 5:00pm (days)

LOCATION: Onsite at LSI Solutions in Victor, NY

SALARY PAY RANGE: $150,000yr to $220,000yr

JOB SUMMARY: The Medical Affairs Director leverages their cardiac surgical experience to provide medical and scientific leadership in support of global regulatory submissions, clinical evaluation, and post-market surveillance at LSI Solutions. The Medical Affairs Director leads medical and scientific initiatives across our product platforms. The Medical Affairs Director also leads a Medical Liaison Team supporting a variety of surgical specialties, which may include cardiac surgery, general surgery, urology, and neurology. The Medical Affairs Director also engages key opinion leaders on device efficacy, safety, and future product development needs. This role is critical in shaping clinical development strategies, guiding regulatory submissions, and supporting cross-functional teams to ensure the safe and effective use of our products. The Medical Affairs Director leverages clinical and research experience to direct and provide expert opinion on and review of relevant risk assessment documentation related to LSI medical devices throughout the design and development process. The Medical Affairs Director also leads the Surgical Science Team, including overseeing the conduct of in-house and external simulated tissue, ex-vivo animal, in-vivo animal, and cadaver studies and usability studies, including developing scientific protocols, lab procedure plans, lab research plans, and final reports. The Medical Affairs Director also works with the Surgical Science Team to publish papers on LSI’s technology, research, and surgical procedures using LSI technology in world class medical and scientific journals.

REPORTS TO: Executive Director of Regulatory Affairs and Quality

SUPERVISES: Yes

ESSENTIAL FUNCTIONS:

• Spearheading the creation of documentation related to targeted clinical studies regarding LSI devices, including investigators brochures, scientific protocols, Institutional Review Board (IRB) or Ethics Committee (EC) submissions, case report forms, training materials, and final reports.

• Leveraging expertise and knowledge in surgery and surgical procedures, medical diagnosis, and treatment standards to collaborate on clinical evaluation plans, clinical evaluation reports and benefit risk analysis for regulatory submissions. Identifying clinical evidence gaps, proposing and/or leading the execution of evidence development strategies to address them. Aligning clinical strategies with commercial objectives.

• Providing medical and scientific leadership in preparing global regulatory submissions.

• Overseeing the generation, analysis, and communication of scientific data from pre-clinical and clinical evaluation of devices. This includes contributing to and reviewing clinical study reports.

• Leveraging clinical and research experience to direct and provide expert opinion on and review of relevant risk assessment (uFMEA, pFMEA, PHA, FRA) documentation related to LSI medical devices throughout the design and development process.

• Contributing clinical expertise to health risk assessments, health hazard evaluations, and adverse event reports as needed. Supporting post-market surveillance.

• Developing and leading the execution of podium and publication strategies in collaboration with internal and external stakeholders (e.g., physician investigators, KOLs) to ensure maximum effectiveness in the execution of the scientific communication plan and maintenance of LSI’s presence at national and international conferences while ensuring compliance with all regulatory requirements.

• Leading the development of materials for internal and external medical education, publications, and responses to medical inquiries from healthcare providers. This will include implementing targeted teaching sessions and summits.

• Building and maintaining relationships with key opinion leaders (KOL), scientific organizations, and the broader medical community in order to provide input to the LSI product pipeline and actionable feedback on existing LSI products. This should include building and overseeing a team of Medical Liaison staff who are dedicated to creating and maintaining meaningful ongoing professional relationships with KOL.

• Providing direction for LSI’s Surgical Science Team, including overseeing the conduct of in-house and external simulated tissue, ex-vivo animal, in-vivo animal, and cadaver studies, including developing scientific protocols, lab procedure plans, lab research plans, and final reports.

• Working with the Surgical Science Team to publish papers on LSI’s technology, research, and surgical procedures using LSI technology in world class medical and scientific journals.

• Partnering with product development and marketing to define clinical requirements.

• Reviewing promotional and training materials for scientific accuracy and compliance.

• Spearheading the conduct of formative and summative usability studies as expert user and/or facilitator.

• Overseeing literature searches, including print and online resources to gather information, check facts, proofread, and edit research documents to ensure accuracy.

• Developing, continuously tracking, and maintaining KPI for the Surgical Science and Medical Liaison Teams to ensure alignment with strategic LSI and Departmental goals.

• Attending surgical cases and laboratories at hospitals, clinics, etc.

• Collaborating with Sales and Marketing and Art departments to create and update effective training documents (i.e., IFU, sales brochures, powerpoint presentations, videos) and programs as well supporting the team for training labs and trade shows.

• Collaborating with other departments as necessary, including but not limited to Discovery, Sales and Marketing, Engineering, Regulatory, Intellectual Property, and Art.

ADDITIONAL RESPONSIBILITIES:

• All other duties as assigned.

EDUCATION & EXPERIENCE:

• Doctor of Medicine (MD) with cardiac surgical experience is required.

• A Nurse Practitioner (MSN or DNP) or Physician Assistant (MPAS or MSPAS) may be considered provided such applicant has at least 5 years of experience supporting cardiac surgery in an operating room.

• Five + years of experience in the operating room is strongly desired.

• Knowledge of diagnosis and management of cardiac or cardiovascular conditions, preferably involving heart valve replacement & repair, revascularization, and cardiovascular procedures is preferred.

• Experience in minimally invasive surgery, treatment standards, medical alternatives, and current technology is especially desirable.

• Relevant work in the medical device industry is a plus, with experience in Quality Management Systems, Risk Management, or device Design & Development desirable.

KNOWLEDGE, SKILLS & ABILITIES:

• Proficient in MS Word, Excel (including statistics), PowerPoint, Adobe Acrobat.

• Document review, editing, and input skills required; strong public speaking skills required; proficient in medical writing; oral and explanatory skills are essential.

• Works well individually and in a team environment; willing to provide feedback to others and embrace constructive criticism.

• Highly detail-oriented, organized, and cognizant of need for consistent & professional work product.

• Ability to consistently deliver results within established deadlines.

• Ability to maintain multiple projects simultaneously.

• Familiarity with surgical operating room procedures, techniques, workflow, and standards.

• Working knowledge of medical device development, regulation, and regulatory processes is a plus.

• Familiarity with regulatory standards such as ISO 14971 (Application of Risk Management to Medical Devices), or a willingness to train to comprehend standards, is required.

• Strong working knowledge of 21 CFR Part 58 (Good Laboratory Practice for Non-Clinical Laboratory Studies).

• Familiarity with EU Medical Device regulations related to Clinical Evaluation.

• Expert in the development of scientific/medical conference proceedings and manuscript publication in major scientific journals.

• Expert scientific acumen, for use in various circumstances, including in working with internal stakeholders and with physicians in identifying evidence gaps and opportunities.

• Demonstrated, successful track record in people management.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands of the roles described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Other demands include:

• Frequently required to sit, stand, and talk or hear, sometimes for several hours at a time.

• May be required to occasionally bend and lift and/or move up 20 pounds.

• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

• Standing or sitting for extended periods (3+ hours) in labs, cases, and at conferences.

• Some travel is required.

LSI SOLUTIONS® BENEFITS INCLUDE:

• Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts

• 15 Paid Holidays, PTO, Sick Time

• Medical, Dental, Vision effective first day of employment

LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.

Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.