Senior Director, OTC Innovation
BestCo
- Mooresville, NC
- Permanent
- Full-time
- Partner with the Commercial team to define the strategy and pipeline to deliver a high value OTC portfolio and effectively engage key customers; defining key design criteria and delivering the technical program that meets them.
- Define and deliver technology solutions.
- Combine pharmaceutical and confectionary science to create breakthrough OTC products.
- Lead the product and analytical development process from ideation to commercialization, working closely with sales, marketing, and operations teams to bring new products to the market and develop customers to meet growth objectives.
- Collaborate with Value Stream Leaders to successfully scale-up and commercialize products, and drive manufacturing efficiencies while maintaining key design criteria.
- Actively manage the portfolio/projects, capturing development activities, managing key risks, addressing any resource gaps, and driving key decisions with the team and executive leadership.
- Optimize and manage the product development process to drive further efficiency and compliance.
- Define and implement new best-in-class tools, techniques, and approaches that improve technical efficiency.
- Actively participate with cross-site R&D leadership team to help build a high-performance cross-site culture that fully leverages and develops talent, including supporting the optimization of the company’s approach to innovation and improved capabilities.
- Develop a best-in-class technical organization that combines excellence in drug product development with confectionary science.
- Cultivate a productive, collaborative environment across different product teams and functional teams.
- Provide site and company leadership by participating and driving key company initiatives through the Site Leadership Team (SLT).
- Set a clear vision for the organization and create a winning team to deliver against business goals.
- Coach, mentor, and educate the organization on New Drug Application and other processes to build capability and ensure the organization is fit for purpose.
- Define and manage the resources needed to deliver the technical program, including the budget, organizational structure, and infrastructure.
- Review and analyze proposals submitted to determine if benefits derived and possible applications justify expenditures.
- Actively develop supplier relationships and leverage consulting firms where necessary to access new capabilities.
- Negotiate contracts with third parties as needed to access additional capabilities.
- Travel (up to 30%) to engage with suppliers and development partners as needed, with some international travel possible.
- Recruit, hire, train, develop, and mentor department staff, evaluate staff performance, and develop goals and objectives to create an empowered high-performance team and cultivate top talent.
- Actively develop organizational and individual employee capabilities, creating a culture of continuous improvement to deliver best-in-class results.
- Bachelor’s degree in a science discipline relevant to pharmaceutical product development (e.g., chemistry, chemical engineering, pharmaceutical sciences, etc.)
- 15 years’ experience in Research & Development with extensive experience developing and commercializing both oral monograph and NDA drug products.
- 10 years’ progressive professional leadership and management experience.
- Comprehensive experience of OTC product development across 505.B.2/NDAs & monograph drugs in US.
- Entrepreneurial spirit and sense of ownership to maximize the value of their business.
- Ability to effectively engage and drive action with senior leaders internally and externally, including senior customer leaders, executives, and board members across technical areas and the business.
- Ability to represent the company and products with major FMCG/Pharma/retail customers, to be able to speak their language, communicate and influence.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Business acumen and agility to apply pharmaceutical insights and approaches to confectionary forms, to quickly adapt to new challenges, and address them.
- Demonstrated ability to maximize the impact of the team in both technical and cross functional workstreams.
- Proven ability to coach, mentor and educate the organization on New Drug Application process, to build capability, and ensure the organization is fit for purpose.
- Ability to integrate multiple technical and business needs to define clear objectives, success criteria, and action steps for programs.
- Ability to analyze complex data to determine gaps/inefficiencies in processes and drive improvements.
- Proficiency in Microsoft Office including Excel and Outlook.
- Demonstrated practical problem solving and trouble shooting skills. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
- Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems.
- Master’s or PhD in a science discipline relevant to pharmaceutical product development.
- Experience in food science/ confectionary based product development.
- Experience in contract manufacturing and branded products.
- Experience leading analytical method development.
- Advanced proficiency in Microsoft Office, enterprise resource planning (ERP), and/or customer relationship management (CRM) software.