The Director of Research & Clinicals - Americas is responsible for the financials, development, planning, and operation of long term research and development as well as clinicals. Reporting to the Vice President of Science & Technology, the incumbent will have accountability over the R&D and clinical departments in the Americas and will work with R&D International, as well as the fermentation, analytical chemistry and food departments to bring unique, game changing, safe, efficacious, high margin new products to the supplement market through in vitro and in vivo techniques. The incumbent is accountable for ensuring accurate, precise, reproducible, presentable, and publishable works on existing and new technologies. The scope of responsibility for this position crosses multiple departments within Deerland Probiotics & Enzymes (e.g. Quality Control/Assurance, Sales, Marketing, etc.). Therefore, the incumbent needs to collaborate with various departments and institutions. They will lead, facilitate, and support the improvement of staff through regular communication regarding expectations, priorities, business results, and performance. Additionally, the incumbent will develop and validate experiments and protocols, write reports (internal and external); present results to senior colleagues, customers, and vendors and coordinate clinical study related activities of clinical research trials.
Key Responsibilities include, but are not limited to the following:
• Lead R&D and clinical efforts from project inception to completion/revenue generation; meet or exceed all deliverables associated with R&D, new product development, and financials
• Provide project management oversight and technical leadership as needed for new product development and enzyme/microbial cell culture innovation platform development.
• Oversee project activities and development of new product concepts in conjunction with Business Development for digestive, sports, animal and clinical nutrition development ; collaborates with 3rd parties in local and international networks.
• Lead clinical trials in the Americas; responsible for all documentation relative to clinical trials including but not limited to clinical contracts, narrative, IRB, data, IP and publications.
• Develop and oversee regulatory and agency science interactions and funding applications, such as GRAS documents, patent applications and grant submissions.
• Development of laboratory technical base and of literature and communications material working with Marketing.
• Coordinate internal resources, third party laboratories and vendors for the execution of assigned projects.
• Build/implement detailed R&D work plan to fulfil company’s project(s) objectives
• Identify new technologies that will enhance the growth of Deerland Enzymes portfolio in terms of enzymes, probiotics, prebiotics, botanicals or other.
• Oversee the development, improvement, validation, and implementation of new product development and new market penetration via technology-based solutions
• Work with project manager(s) to create and be accountable for the R&D aspects of the stage gate and RACI processes.
• Improve and expand the Company’s knowledge of new ingredients/technologies for new and existing markets as applicable
• Create and stay within department budget.
• Collaborate with industry professional to expand new application development opportunities
• Handles, prepares, and works with biological samples such as blood, fecal matter, and other bodily fluids
• Develop and monitor study related budgets and provide reports as required to department administration and funding agencies
• Establish and maintain laboratory collaborations with Universities.
• Leads and manages department staff through effective planning, mentoring, directing and coordination of development activity
• Oversee the development, improvement, validation, and implementation of animal and human clinical trials for the Americas
• Record, interpret, and present results to senior colleagues, customers, and vendors
• Build/implement detailed clinical research work plan to fulfil project objectives.
• Improve and expand company’s knowledge of new ingredients/technologies for new and existing markets as applicable
• Meet clinical objective numbers within clinical budget.
• Work with project manager(s) to create and own the clinical portions of new technology state gates and RACI’s.
• Collaborate with industry professional to expand new application development opportunities
• Provide leadership, motivation, and performance based culture within the technology team
• Handles, prepares, and works with biological samples such as blood, fecal matter, and other bodily fluids
• Ensure compliance with all relevant IRB, HIPAA, GCP and other regulatory agency requirements. Ensure ongoing training, certifications, and compliance with current regulations
• Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports
• Provide leadership, motivation, and performance based culture within the technology team
Research Responsibilities:
• Train technicians in new methods and R&D and clinical work
• Maintain familiarity with current scientific literature and contributes to the process of a project
• Identify problems or obstacles in the system/procedures related to implementation of the research protocols
• Handle, restrain, and transport animals in a safe and humane manner for animal model studies
• Carry out routine tasks and follow strict methodologies to carry out analyses
• Oversee the investigation, creation, validation, and development of new methods, protocols, and technologies for Quality Control/Quality Assurance/R&D
General Responsibilities:
• Oversee the development, improvement, validation, and implementation of New market penetration via technology based solutions
• Develop and monitor study related budgets and provide reports as required to department administration and funding agencies
• Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports
• Contribute ideas and concepts to initiate or advance projects
• Initiate and ensure compliance with applicable safety procedures
• Publish in vitro and in vivo work done through Science & Technology
• Leads and manages department staff through effective planning, mentoring, directing, and coordination of development activity
• Record, interpret, and present results to senior colleagues, customers, and vendors
• Develop, as warranted, prototypes for range of products based on company’s technology
• All other assigned duties
Clinical Responsibilities:
• Train technicians in new methods, clinical trials, and R&D work
• Coordinate Clinical protocols including: scheduling necessary appointments and procedures, work collaboratively with other departments and institutions, and maintain regular contact with study participants
• Oversee/conduct recruitment, screening, enrolling and obtaining informed consent forms
• Handle, restrain, and transport animals in a safe and humane manner for animal model studies
• Oversee the collection, analysis, and dissemination of Clinical data
• Develop, implement, and maintain comprehensive databases and files
• Prepare IRB documents and reports using electronic systems
• Publish results
Education Required:
• Ph.D. in Sciences (Chemistry, Biochemistry, Food Science, etc.)
Experience Required:
• Minimum of 7 years of industry / directly related experience
• Enzyme and microbial background
• Proven track record of successfully leading R&D projects from start to finish
• Previous supervisory and/or managerial experience
• Proven track record in attracting, retaining talent, and addressing performance issues
• Proven ability to manage multiple / competing priorities
• Strong decision making skills
• Ability to troubleshoot
• Grant writing
• Patent writing
• Quality control and knowledge of cGMP
• Independent research projects
• Strong attention to detail in order to produce accurate, precise, and reproducible data to support scientific investigations
• Strong analytical, organizational, and time management skills
• Task oriented and results driven
• Strong work ethic and prioritization skills
• Design, collect, and write publishable work
• Work collaboratively with various departments to compile, analyze, and interpret data
• Excellent written and oral communication skills – ability to make presentations and/or give presentations; Proficient in MS Office, Project, Excel, and PowerPoint
• Must possess a U.S. driver's license
• Must be able to travel between local sites: 50-75%
• Out of state travel: Occasional (<25%)