Silk Road Medical is hiring! We are looking for candidates to join our team for the following positions:
Therapy Development Specialist/Clinical Specialist
Summary: The Silk Road Medical Therapy Development Specialist is an entrepreneurial ambassador for a new hybrid procedure to treat carotid artery disease: TCAR (Transcarotid Artery revascularization). As part of the commercial field team he/she will lead the next revolution in endovascular surgery to execute market development and therapy adoption initiatives in TCAR Centers of Excellence, prospect new commercial opportunities, become a trusted clinical partner and TCAR specialist to drive safe adoption, superior outcomes and achieve sales revenue targets of the ENROUTE Transcarotid Neuroprotection System, ENROUTE Transcarotid Stent System and related products. The Silk Road Medical Therapy Development Specialist practices excellent relationship management with customers, with strong organization, administration and expense planning and control. The Silk Road Medical Therapy Development Specialist is a partner and resource to the SRM cross functional teams, including Sales, Field Clinical, Professional Medical Education, Marketing, Research and Development.
Candidates applying for the position of Therapy Development Specialist should have:
- Entrepreneurial, experience in building a business, and new therapy adoption.
- Deep knowledge of the care and management of carotid artery disease. CEA, CAS, and TCAR.
- Deep knowledge of Healthcare Economics and Reimbursement. Ability to understand/sell a clinical and economic value proposition.
- Experience converting open surgical procedures to endovascular alternatives.
The Successful candidate must possess:
- Bachelor’s Degree
- 5+ year’s sales and/or clinical experience in a hospital environment; selling into minimally invasive cardiovascular market, EVAR/TEVAR, TAVR, peripheral or surgical related products.
- Demonstrated success in previous sales role; indicating a high level of sales performance, influence and selling skills.
- Demonstrated experience in Carotid Artery Stenting and/or neurovascular.
- Previous experience in a start-up environment.
- Exceptional business and clinical acumen with prior experience leading a sophisticated cardiac or endovascular procedure.
- Exceptional understanding of cardiovascular, physiology, and relevant anatomy and pathology.
- Interventional peripheral vascular or coronary/cardiac procedural experience (wires, balloons, catheters, stents). Endovascular-specifically Endo Vascular Aneurysm Repair (EVAR}and Thoracic Endo Vascular Aneurysm Repair (TEVAR}-or Cardiac surgery, Surgical Aortic Valve Replacement (SAVR), Transfemoral Aortic Valve Replacement (TAVR) experience preferred.
- Strong, proven medical device sales track record with documented growth and achievements.
- Experience in converting an open surgical procedure to an endovascular alternative. Knowledge of the unique market development challenges with this type of procedural conversion sale.
- Previous experience communicating product’s market advantages to physicians and hospital administration.
- Experience managing multiple accounts.
- Successful experience launching a new device.
- Market development experience.
- Experience calling on C-Suite customers.
- Prior experience teaching and educating medical personnel, peers and technical support personnel.
- Imaging interpretation experience (Carotid Duplex Ultrasound, CTA, MRA, catheter angiography) Computer proficiency and ability to perform CT reconstruction with CT programs. Experience in Hybrid OR settings and various angiography imaging from C-Arm to angio suite.
- Experience in the Operating Room environment. Knowledge of sterile field, operating room dynamics, and personnel.
- Demonstrated success building strong relationships with key therapy users and employees across organizational level.
- Ability to effectively organize and plan travel schedule with frequent last minute requests.
- Ability to travel with overnight stay up to 50- 75% of the time (geography variability)
- Previous peer and physician education experience.
- Excellent influencing and consulting skills
- Excellent interpersonal and written communication skills.
- Ability to make timely and sound decisions
Below are the following cities/areas we will be recruiting for:
- Midwest (Kansas City, St Louis, Omaha, Des Moines)
- Gulf Coast
- South Texas
- Southern California
- Georgia (Atlanta)
- North Carolina (Charlotte or Raleigh)
- Philadelphia Corridor (NJ to DC)
- Upstate New York (Rochester / Syracuse)
Marketing Product Manager
Summary:The Product Manager (PM) will drive upstream and downstream marketing initiatives for the new Transcarotid Artery Revascularization (TCAR) Procedure for Silk Road Medical. With the Vascular Surgery community as the primary customer, the PM will work closely with internal R&D, regulatory, sales and clinical teams to develop and launch new adjunctive products and create a best in class marketing and market development materials for physician customers, hospital marketing departments and our field sales and clinical organizations.
The candidate in this position will conceive, develop, launch and train to new marketing materials to support additional product sales and effectively broadcast the value proposition of the novel TCAR Procedure. Listed below are some of the key deliverables for the Silk Road Product Manager.
- Foster strong relationships with key, experienced physicians and hospital staff to better understand the clinical needs of carotid artery revascularization from our vascular surgery customer base.
- Work closely with R&D and our physician customers to design, develop and launch a portfolio of adjunctive products to ensure consistent procedural success of the ENROUTE® Transcarotid Neuroprotection and Stent System.
- Develop deep relationships with key manufacturers and their extended internal teams (Regulatory, marketing, sales, supply chain) to design, develop and deliver our forecasted volumes of products to support global product demand.
- Create and launch technical and clinically-based marketing materials to support a deeper understanding of our products, procedure and outcomes.
- Support the continuous improvement of the Silk Road website and marketing collateral through patient, physician and customer-based testimonials through language, videos and animations.
- Work closely with physician customers to create product preparation and live case videos to support the training and education of current and future users.
- Work with Professional Education to develop benchtop models that can be used to train physicians and OR staff on the procedural steps of the TCAR Procedure.
- Attend trade shows and events to capture physician feedback and promote the TCAR procedure.
- Comply with all regulatory and clinical requirements in marketing materials and messaging.
- Participate in evaluation, development and refinement of marketing materials and programs in a creative, dependable, and flexible manner to achieve a high-quality work-product.
- Work closely with Operations and Supply chain to accurately forecast product demand through launches, portfolio transitions and end of life cycles.
- Perform other duties as assigned by VP, Marketing and senior staff of Silk Road Medical.
Desired Skills and Experience:
- 3-5 years of up/downstream product management experience in the medical device space, preferably working with vascular or endovascular specialists with a preference for a work history with vascular surgeons or experience in the carotid vasculature
- Demonstrated clinical experience related to surgical and/or endovascular device market with ideally, experience in vascular surgery, surgical and interventional vascular devices, and operating room etiquette
- Professional work ethic, strong organizational skills, and ability to operate independently
- Strong interpersonal skills, experience working with surgeons in the OR setting and/or endovascular specialists in the interventional suites
- MBA is preferred
- Ability to travel up to 30% of the time
- Computer skills: Microsoft Word, Excel, PowerPoint required with live case and animation video editing skills preferred
- The position is based in the home office of Sunnyvale, CA and reports to the VP, Marketing
Senior Regulatory Specialist
Summary: Coordinate the timely preparation of world-wide regulatory submissions and product updates for products and to facilitate the evaluation and approval process with the regulators to ensure timely approval of products. Assist in developing department policies, procedures, and strategy. Work with development teams to identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Evaluate proposed changes to the quality systems and all changes related to the products for impact to regulatory filings. Monitor changing regulations, guidance documents and standards and determine impact to quality system or products.
- Provide regulatory input to product lifecycle planning
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Determine submission and approval requirements
- Monitor trade association positions for impact on company products
- Identify and address regulatory obstacles and emerging issues throughout the product lifecycle and assist in developing solutions
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing
- Compile, prepare, review and submit regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies
- Monitor applications under regulatory review
- Communicate application progress to all appropriate departmental personnel
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Oversee processes involved with maintaining annual licenses, registrations, listings
- Ensure compliance with product postmarketing approval requirements
- BS preferred in Life Sciences or other technical discipline
- Minimum 5 years of experience in regulatory affairs.
- Excellent written and verbal communication skills.
- Knowledge of regulatory requirements.
- Proficient in Word, Excel, PowerPoint and Adobe Acrobat.
- May require travel.
Interested candidates should submit their resume to firstname.lastname@example.org. Please list the region and position you are applying for in the subject line of the email.