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Vice President, Medical Affairs
2 months ago
Purpose:
The Vice President of Medical Affairs is a strategic, experienced scientific/medical leader responsible for building and leading a high-performing Medical Affairs function.
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 Dialitys regulatory approvals for our and support of commercialization efforts.
Duties & Responsibilities:
• Define and establish a Medical Affairs vision and strategy for Diality, building an operational Medical Affairs Organization to support the launch of Denali and all future programs supporting expansion of its 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.
Qualification 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.
• Have a strong compliance mindset and excellent understanding of relevant GCP, ICH and FDA/ EMA regulations.
• Have excellent written and spoken English communication skills.
Physical Demands:
The employee may occasionally lift and/or move up to 25 pounds.
Travel:
Ability to occasionally travel domestically and internationally
• 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The duties listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
