VP, Research & Clinical Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and manage the HHT Clinical Trial Network along with Cure HHT’s partnerships with biotech and pharmaceutical companies.

• Be a part of the leadership team and report directly to the CEO.

• Retain and expand the membership of the Clinical Trial Network.

• Implement tailored programs in accordance with member sponsorship agreements.

• Organize member update meetings and Annual Reviews while providing reports on contractual obligations.

• Nurture the member pipeline and assist in acquiring additional members.

• Enhance patient recruitment and facilitate referrals to trial sites.

• Oversee prescreening, referral routing, and the handoffs between CTN and CROs.

• Direct trial-ready operations throughout Centers of Excellence, which includes site identification, qualification, activation, and operational support.

• Liaise with CROs and biotech/pharma sponsors regarding trial design and implementation.

• Supervise two Research Coordinators, as well as biostatistics and regulatory consultants, along with the Senior Director of Research Programs & Grants Management.

• Develop the clinical-trial team progressively as membership revenue allows.

• Manage the commercial positioning and administration of the patient registry.

• Regulate member access to registry data, biospecimens, and the clinical-trial application while upholding patient-data protections.

• Collaborate with the COO on contracts, SOWs, invoicing, payment timelines, and logistics for conferences/events.

• Ensure precise operational and financial reporting for the therapeutics division.

• Maintain compliance with anti-kickback regulations, OIG guidance, IRS rules, debarment/exclusion screening, confidentiality requirements, and research/IRB standards.

• Act as the operational and commercial representative for Cure HHT in therapeutic partnerships and regulatory advocacy.

⛳️ Requirements

• A Master’s degree in a scientific or healthcare field is required.

• A minimum of 10 years of relevant experience in clinical research operations within pharma, biotech, and/or CRO environments.

• Proven success in managing commercial or partnership relationships with pharmaceutical/biotech sponsors.

• Experience in CRO oversight and clinical-trial operations.

• Exceptional leadership and people-management skills, with a history of building and overseeing teams alongside cross-functional consultants.

• Strong organizational skills, meticulous attention to detail, and the ability to juggle multiple high-stakes priorities and member relationships at once.

• Excellent oral, written, and interpersonal communication abilities.

• Willingness to travel as needed (approximately 30%).

• Preferred: An advanced degree (PhD, MD, MPH, or MBA).

• Preferred: Familiarity with nonprofit/for-profit sponsorship compliance (anti-kickback, OIG, tax-exempt regulations).

• Preferred: Experience in rare disease or vascular disease contexts.

• Preferred: Experience collaborating with CRO partners and principal investigators at trial sites.

• Preferred: Experience in managing consortiums or clinical networks.

🏝️ Benefits

• Comprehensive benefits package.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Generous PTO.

• Remote work options.

• Opportunities for professional development.