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Joining a Series-B stage startup in one of the most exciting MedTech spaces means you will have the opportunity to help re-chart the journey of patients with kidney disease.
 
Apply online and explore your potential role on our mission-driven team.
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Medical Affairs

Vice President, Medical Affairs

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Diality Inc., a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment.

We are looking for a Vice President, Medical Affairs who will leverage experience as a strategic scientific/medial leader to build and lead a high-performing Medial Affairs Organization. Reporting to the CEO, this newly created position will ensure effective medical and scientific partnerships with relevant healthcare providers and patient stakeholders in support of all Diality's regulatory approvals and commercialization efforts.

Essential Duties, Responsibilities, and Expectations

Revenue Recognition Responsibilities

  • Define and establish a Medical Affairs vision and strategy for Diality, building an operational Medical Affairs Organization to support the launch of all current and future programs supporting expansion of Diality's hemodialysis system's use into the home environment and other markets with a small, nimble team of top medical talent to build an integrated Medical Affairs function.
  • Establish and oversee relevant systems and processes to support business needs and ensure compliant, consistent, and ethical operations reflecting the values     of the organization.
  • Lead all clinical trial activity the organization participates in, including study planning, design, execution of key pivotal trials, compliance, and audits.
  • Develop Educational programs involving Internal Educations, Physicians Patients and Compliance.
  • Lead Scientific Communications management with publication strategies, abstracts, manuscripts, podium presentations, and actively participate and present on the podium in relevant scientific meetings and educational events.
  • Manage unrestricted grants, medical information, health economics and outcomes research, and investigator-initiated trials that meet key strategic needs of the company.
  • Lead the clinical operations team to cover Device safety, Clinical Data Management and Biostatistical analysis internally or externally as appropriate.
  • Collaborate with the commercial organization to develop a comprehensive post market approval research strategy to support our product’s value proposition     (clinical and healthcare economic) in targeted clinical settings and develop a strategy for communicating our clinical and healthcare economic evidence to external stakeholders with the commercial team.
  • Key Opinion Leader management through the company’s clinical advisory board (CAB) and study steering and publication committees.
  • Establish and maintain contacts with external partners such as university groups, KOLs, investigators, patient advocacy groups, industry groups and consultants.
  • Evidence Based Medicine knowledge and competitive landscape management.
  • Act as the primary clinical reviewer of advertising, promotional material, and upstream marketing escalation point for Diality, including but not limited to medical related questions/issues from Diality Sponsored projects.
  • Act as the primary clinical escalation point for Quality and provide strategic input for R&D and New Business Development.
  • Working with the head of marketing develop a customer-relationship management platform, that includes identifying, engaging, and managing relationships with dialysis key thought leaders; major national and international dialysis organizations; dialysis patient advocacy groups; University, VA and DOD dialysis departments, and similar international relationships.
  • Lead the development and adoption of processes to accommodate new or changing external requirements in support of medical affairs activities, keeping current with regulations and requirements in the global environment including regulatory affairs authorities.

Qualifications & Requirements

  • An experienced Medical Affairs leader with 10+ or more years of medical device or -pharma industry experience with a strong background in Medical Affairs, particularly in the U.S.
  • Significant Medical Affairs experience in nephrology is required and should hold an active US Medical License and have a working knowledge of the US dialysis     industry.
  • Have previously built or expanded a Medical Affairs department with additional capabilities and experience driving successful launch and post-launch     medical/scientific product support throughout the life cycle is preferred.  
  • Comfortable in a fast-paced and evolving environment and have demonstrated ability to align the Medical Affair function with the growth of a company or     organization.
  • Work effectively in a small team environment and can roll up your sleeves to ensure all department goals are achieved.
  • An inspirational people leader recognized for building and managing high-performing cross-functional teams.
  • Naturally collaborative medical leader who can drive exceptional cross-functional partnerships and scientific exchange with diverse internal and external     stakeholders.
  • Strong compliance mindset and excellent understanding of relevant GCP, ICH and FDA/ EMA regulations.
  • Excellent written and spoken English communication skills.

Base Salary

$273,961/yr - $365,000/yr

Exact compensation may vary based on skills, experience, and location.

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Sales and Support

Warehouse & Customer Support Coordinator

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Warehouse & Customer Support Coordinator

Location: San Diego

LinkedIn: https://www.linkedin.com/jobs/view/3782265457/?capColoOverride=true

 

About Us:

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.


The Warehouse & Customer Support Coordinator located in Vista, CA will report to the Director of Customer Operations and be responsible for ensuring the efficient and secure handling of our innovative hemodialysis system. As a Warehouse & Customer Support Coordinator, you’ll have a unique role of providing tier 1 customer support and serving as a dedicated customer resource and liaison for issue resolution. You will provide exceptional customer support by answering incoming calls and emails, perform basic troubleshooting steps for the device and gather necessary information for the engineering team to accurately diagnose issues, understand root causes and apply appropriate solutions. The other dynamic of this role is manage the inventory transactions of a warehouse including accepting inbound shipments, performing incoming acceptance procedures, performing inventory management activities, and the preparation and coordination of outbound shipments to our customers.


Duties & Responsibilities:

Tier 1 Customer Support:

·        Provide exceptional and timely tier 1 customer support to address inquiries, process orders, resolve issues, and assist customers with technical or clinical questions          related to our medical device.

·        Effectively manage inbound calls, emails, and other communication channels to ensure customer inquiries are addressed promptly and professionally.

·        Maintain a deep understanding of our device, operations, and services to provide accurate and helpful information to customers.


Customer Liaison for Product Issues:

·        Act as a dedicated point of contact for customers, ensuring their concerns and issues are addressed with empathy and professionalism.

·        Collaborate with internal cross-functional teams, including technical support and product engineering, to resolve complex product-related issues and coordinate          solutions.

·        Liaise with field-based customer support teams including field service and clinical training

·        Keep accurate records of customer interactions and report trends or recurring issues to the product development team for continuous improvement.


Shipping and Receiving:

·        Process incoming and outgoing shipments, including accurate documentation and coordination with carriers and couriers.


Inventory Management:

·        Maintain accurate inventory records, conduct regular stock counts and ensure the timely replenishment of stock levels.


Quality Control:

·        Inspect incoming and outgoing shipments for quality and compliance per company standards.


Organization and Layout:

·        Maintain an organized and efficient warehouse layout, optimizing space and ensuring a clean, safe working environment.


Safety Compliance:

·        Adhere to all safety protocols, including the proper handling and storage of medical devices and the use of personal protective equipment (PPE).


Compliance:

·        Ensure all warehouse activities comply with company policies and relevant regulations, including those pertaining to medical device storage and transportation.


Minimum Qualifications:

·        High school diploma/GED or work experience equivalent (Bachelor's degree in a related field is a plus).

·        2+ years of experience in warehouse coordination or a similar role.

·        2+ years of experience in a customer support, customer success, or project coordination role.

·        Active certification to operate a forklift and understanding of safety regulations and best practices in a warehouse setting is required.

·        Experience with SaaS based software systems and CRMs and ERPs and experience in inventory management.


Preferred Qualifications:

·        Knowledge of medical devices and healthcare industry best practices a plus

·        NetSuite experience a plus.


Skills & Abilities:

·        Strong interpersonal and communication skills, both written and verbal.

·        Ability to work independently, solve problems, and make decisions.

·        Strong organizational skills and attention to detail.

·        Excellent communication and teamwork skills

·        Ability to work in a fast-paced environment


Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Will require walking, primarily on a level surface for periods of time throughout the day. The employee will be required to stand, walk, climb or balance, stoop, kneel, crouch or crawl and talk or hear. Proper lifting techniques will be required to lift up to 75lbs.


Working Environment:

This position primarily works in a warehouse environment. It requires frequent sitting, standing, lifting, carrying, and walking. Daily use of a computer and other computing and other digital devices is required.


Travel:

·        No air travel necessary for this position


Hourly Range: $23.96 – $30.76 DOE

Application Form

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