Vp, Clinical Development & Operations

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.Veloxis Pharmaceuticals, Inc.

• Leads and manages the Clinical Research and Clinical Operations department ensuring that the vision and direction of the group meet the mission and goals of the Company, the quality of the research is at the standards required by the Company and FDA, and that timelines and budgets are achieved.
• Collaborates with members of other functions in the Company (e.g., Regulatory Affairs, Medical Affairs, Pharmaceutical Development, Sales/Marketing, et al.) to achieve corporate goals.
• Manages all clinical operations activities, internal and external, on behalf of the Company ensuring high quality data generation in support of its commercial product and pipeline programs.
• Leads interactions with external thought leaders and KOLs to help formulate clinical strategies and development plans to deliver the best possible outcomes for Veloxis ‘s product development.
• Develops strategies and leads implementation of clinical outsourcing including selection of vendors, CROs, and other external resources needed to successfully operationalize clinical development at Veloxis.
• Works with the Company’s Business Development team and other colleagues to develop in-licensing strategies and provide key review and feedback on potential product candidates.
• Develops subject matter expertise in the therapeutic areas of interest to the Company and clearly communicates, both internally and externally, the science behind Veloxis’s products and pipeline.
• Develops, authors, and reviews regulatory documents (e.g., briefing documents, IND, NDA, etc.) and study-related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.) and leads the clinical team in interactions with the FDA and other regulatory authorities.
• Provides leadership in defining the development strategy for products in development (e.g., pipeline products, LCM programs, etc.), in designing studies and in the conduct and management of clinical studies.
• Provides leadership experience to the running of clinical trials including identifying program risks and developing mitigation strategies to ensure clinical programs stay on time and within budget.
• Provides clinical science research expertise, especially study design and data interpretation to achieve high quality protocol development and execution.
• Directs staff to ensure efficiency for day-to-day operations and to meet the goals of the program.

• Doctor of Medicine (MD) required.
• Experience leading and coordinating the clinical drug development activities of at least one approved product.
• Experience dealing with and solving a variety of development-stage clinical issues of broad scope and complexity.
• Experience writing, reviewing, and editing regulatory and non-regulatory documents.
• Experience leading cross-functional teams.
• Minimum of 15 years’ industry experience, with a minimum of 12 years’ clinical operations and development experience required.

• Analytical
• Excellent teamwork and collaboration skills
• Expert knowledge of scientific principles and concepts
• Outstanding written and verbal communication skills
• Ability to multi-task
• Strong management skills
• Effective process and project management skills
• Solution oriented