‍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.

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Essential Duties, Responsibilities, and Expectations

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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.

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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.

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Base Salary

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

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

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