We are looking for a dynamic cross-functional Vice President to provide regulatory leadership, oversight and guide the strategic development of our products throughout the product lifecycle from preclinical through approval of product(s)/application(s). The VP will lead Regulatory Strategy, Ad-Promo, Regulatory Operations, and Regulatory Clinical/CMC. This position will be responsible for leading the developmental regulatory approval process for INDs, end of phase meetings, and BLAs. This individual will have the chance to make a significant contribution to the future of Pyxis and its stakeholders.
This is a strategic role that requires a strong working knowledge of regulatory procedures and proven success in leading the development of regulatory submissions within Pyxis. This individual will have the primary responsibility for the development, communication, and implementation of Global Regulatory requirements in the overall development and post-approval support of candidate drugs consistent with Pyxis’ corporate goals. As such, the candidate should possess a strong capability for entrepreneurial strategic thinking, is comfortable challenging boundaries in a professional manner, developing non-traditional regulatory paths within regulatory guidelines and regulations, and be comfortable in a high energy and demanding environment.
The VP will report to the Chief Operating Office and as a key member of the senior leadership group and presenting to the Board of Directors at times, will be responsible for developing and implementing global regulatory strategies, establishing and maintaining effective relationships with regulatory agencies especially the FDA, directing US and Ex-US clinical studies, and supporting commercial operations. The candidate will also have responsibility for:
- Working with research, non-clinical development, CMC, and operations to develop regulatory strategies which will creatively position innovative products for expeditious review/approval at regulatory agencies around the world
- Establishing and maintaining highly credible and progressive relationships with the FDA and other regulatory agencies.
- Developing strategic competitive advantage through creative strategy development, application of industry best practices, and highly effective execution of the preparation and submission of regulatory submissions.
- Providing key regulatory leadership in developing registration-filing strategies and CMC dossiers that support flexible and aggressive sourcing strategies.
- Providing senior management with critical risk assessments of the strategic alternatives for regulatory filings.
- Enhancing and maintaining an organization which brings expert science, creativity and innovation; knowledge and regard of regulations; respect for teamwork and others; and a commitment to the success of the business.
- Establishing a regulatory affairs capability that will enhance the effectiveness of partnered product/business development and partner relationships, through communicating and presenting information with regard to in-licensing and out-licensing products
- Interfacing with the quality compliance group to help establish and maintain systems to assure that research and development activities and commercial operations are compliant with all applicable regulations. Additionally, develop and implement department policies, processes and SOPs
- Supporting the planned growth and necessary changes of the Pyxis organization through communication of company vision and strategy, business process improvement, relationship building, critical staffing, personnel growth and development
- Develop and responsible for the development of regulatory staff, performance appraisals, training and recruitment in keeping with the needs of the company
- Advanced degree, Ph.D. in a science field such as Biology, Chemistry, or Pharmaceutical sciences or M.D. is preferred
- 15-20 years of Pharmaceutical/Biotech experience, with at least 10 years’ Regulatory Affairs experience in biologic drug development and registration activities is required
- Senior-level management of an approved new drug from discovery thru late phases
- Candidates must have proven strategic development capabilities related to new drug development
- Strong therapeutic knowledge and experience (Oncology preferred)
- Experience with Fast Track, Orphan Drug and Breakthrough designations and application process
- Must have a strong understanding of HIPAA and the importance of patient data privacy
- An extensive background and excellent relationship in working with the FDA and other regulatory agencies; broad experience in global drug development and international clinical studies
- Must have superior leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
- Good oral and written communications, time management, and team-oriented leadership skills are essential
- Strong collaboration skills and the ability to effectively communicate (written and oral) with internal and external team members on project activities.
To apply, please send resume to firstname.lastname@example.org