Reporting to the Executive Director, Institute for International Crop Improvement, the Director, Product Development and Regulatory, provides leadership across a diverse range of functions, including trait characterization and development, regulatory science and registration, and industry and regulatory affairs. The Director works closely with Danforth Center Principal Investigators and project scientists from various National Agricultural Research Services in countries in Africa, South and Southeast Asia to successfully deliver improved crop varieties developed using both conventional and new plant breeding techniques. The position is located at the Donald Danforth Plant Science Center in Saint Louis, MO, but international travel is a significant requirement of this role.
Leading and participating in cross-functional teams to develop and execute robust strategies for regulatory submissions and securing product approvals for a diverse and expanding portfolio of new crop varieties produced using genetic modification techniques, include gene editing and transgenesis.
Together with project Principal Investigators (PIs), leading the planning and implementation of all aspects of novel trait characterization and development, trait introgression, and germplasm enhancement programs.
Leading the development and implementation of regulatory sciences strategy and preparing regulatory submissions, including compiling submission materials, authoring, monitoring and reviewing, coordinating responses to questions from regulatory authorities to obtain regulatory approvals, and mentoring other project members involved in regulatory functions.
Leading and participating with in-country project teams in the development and implementation of new variety registration, seed production and certification, marketing and promotion, and dissemination plans.
Leading in the coordination and oversight of regulatory compliance and product stewardship across multiple geographies.
Developing and reviewing documents and processes, including: regulatory dossier templates; standard operating procedures and study protocols; policy position statements; project and product promotional material; intellectual property, material transfer, and licensing agreements; and document management.
As required, assembling, coordinating and managing external consultants and/or third-party service providers (e.g., contract research organizations), with accountability for meeting the highest quality standards on-time and on-budget.
Independently keeping abreast of regulatory and seed system procedures and changes across a range of geographies in North America, Africa, South and Southeast Asia.
Leading and participating in meetings with regulatory bodies and agencies.
Establishing and reporting on annual work plans to Danforth Center PIs and project donors, and leading in the preparation of the Institutes Annual Report.
Education and Skills/Experience:
Doctoral (Ph.D.) or Masters degree in chemistry, crop science, toxicology, ecotoxicology, agronomy, biochemistry, bioscience engineering, entomology, microbiology, molecular biology, genetics, plant breeding, plant pathology, or related scientific discipline.
Minimum of ten or more years of relevant experience in regulatory / government / industry affairs in the agricultural and/or biotechnology industry.
Knowledge of and experience with regulatory processes for agrochemical, agrobiological, and/or agricultural biotechnology products in multiple countries, including seed certification and variety registration.
Prior experience coordinating scientists during study process, and with regulatory applications, renewals, public comments, petitions and/or legal challenges.
Strong analytical and conceptual skills, and the ability to think and plan strategically.
Attention to detail and ability to effectively and efficiently perform multiple tasks, and balance competing priorities within a required timeframe.
Track record of leading projects through building stakeholder alignment, and a record of successful interactions with regulatory bodies and/or agencies.
Strong group facilitation skills and the ability to successfully interact with diverse people and teams, and continually build partnerships.
Prior experience supporting cross-functional product development and/or launch teams for new crop varieties.
Professional and diplomatic demeanor and conduct, and proven ability to work sensitively and effectively across cultures.
Ability to travel domestically and internationally approximately 30% of each work year as needs dictate
Ability to operate computer and other office equipment
Ability to sit at a desk for more than one hour at a time
Salary commensurate with experience.
To apply please submit a cover letter, CV, and contact information for at least three references.
About the Donald Danforth Plant Science Center:
Founded in 1998, The Donald Danforth Plant Science Center is an independent, non-profit organization with a mission to improve the human condition through plant science. Our focus is scientific research at the nexus of food, energy and the environment to improve the productivity and sustainability of agriculture. We assemble interactive teams of scientists and develop unique platforms to discover underlying principles about how plants work. We then convert that knowledge into useful crops and products, and partner with organizations that are best positioned to solve problems where they exist around the world. The Center’s work is funded through competitive grants from many sources, including the National Institutes of Health, U.S. Department of Energy, National Science Foundation and the Bill & Melinda Gates Foundation.
The Donald Danforth Plant Science Center is proudly an equal employment opportunity employer. Employment decisions at the Danforth Center are based on merit, qualifications, and abilities. It is our policy that the Danforth Center does not discriminate in employment opportunities on the basis of race, color, religion, sex, sexual orientation, gender identity, age, or national origin and status as protected veterans or individuals with disabilities. If you need a reasonable accommodation to access the information provided on this web site, please contact Human Resources, at 314-587-1033 for further assistance.
The Donald Danforth Plant Science Center in St. Louis, Missouri is a not-for-profit research institute. Scientists at the Center are engaged in research that strives to enhance the nutritional content of plants, increase agricultural production to create a sustainable food supply, reduce the use of pesticides and fertilizer, develop new and sustainable biofuels, and generate scientific ideas and technologies that will contribute to the economic growth of the St. Louis region. The Danforth Center currently employs nearly 200 individuals. Of these, two-thirds are scientists / scientific staff and approximately 90 hold PhDs. The Danforth Center has a strong international presence and commitment. Scientists from more than 20 different countries work at the Danforth Center and the Center has developed collaborations with educational and research institutes in Africa, China and India.