Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, passionate people who thrive in a collaborative team environment.
If you’re looking to make a significant difference with a patient-centric company, then we invite you to learn more about the opportunities available at Veloxis.
Compensation and Benefits
Our success is tied to the contribution of every team member, which is why we provide a valuable, competitive compensation package that includes health and insurance benefits, training and development opportunities, as well as performance-based bonus eligibility.
We currently have the following position available in Cary, NC.
Vice President, Clinical Development & Operations
The Vice President Clinical Development & Operations (CD&O) will be responsible for providing leadership for the Clinical Development and the Clinical Operations teams across all of Veloxis’s development programs. Reporting to the CMO, the incumbent will be on the Company’s R&D and Medical Affairs leadership team. This individual will provide strategic and tactical implementation leadership for all the Company’s assets entering into clinical development from Phase 1 through Phase 3 and also oversee post-approval clinical studies.
Summary of Key Responsibilities:
- 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;
- 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;
- Provides clinical science research expertise, especially study design and data interpretation to achieve high quality protocol development and execution;
- 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;
- Leads interactions with external thought leaders and KOLs to help formulate clinical strategies and development plans in order to deliver the best possible outcomes for Veloxis ‘s product development;
- 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;
- 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;
- 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;
- 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;
- 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;
- 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;
- Directs staff to ensure efficiency for day-to-day operations and to meet the goals of the program.
Required Qualifications and Skills:
- Doctorate degree required. MD preferred;
- Minimum of 15 years of industry experience; with a minimum of 12 years of clinical operations and development experience required;
- Experience leading and coordinating the clinical drug development activities of at least one approved product;
- Experience leading cross-functional teams;
- Experience writing, reviewing and editing regulatory and non-regulatory documents;
- Experience dealing with and solving a variety of development-stage clinical issues of broad scope and complexity
- Travel Requirements: 30%
Skills and Specifications:
- Strong management skills;
- Excellent teamwork and collaboration skills;
- Effective process and project management skills;
- Solution oriented;
- Outstanding written and verbal communication skills;
- Expert knowledge of scientific principles and concepts;
- Ability to multi-task.
Please submit your resume and cover letter to: email@example.com.
Equal Opportunity Employer
Veloxis is an Equal Opportunity / Affirmative Action employer, and will consider all qualified applicants for employment with regard to race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status or disability status.