The VP of Research & Development will define and execute the company's R&D strategy, ensuring the timely delivery drug development, optimization and enterprise deliverables that are innovative, creative, cost effective and cutting-edge scientific solutions. This role will create and execute the company's overall technology vision, manage the appropriate development methodologies, and create a high performing development team to deliver high-quality solutions to the market.
RELATIONSHIPSReports to the CEO. The position works closely with the Quality, Manufacturing, Regulatory and Clinical teams. Will establish internal and external relationships, which may include interactions with various stakeholders, clients, internal/external consultants and organizations, as needed.
DUTIES AND RESPONSIBILITIES- Responsible for the development of innovative scientific and production strategies to support business expansion and new areas of opportunity.
- Oversees the development of chemical synthetic or other pathways for compounds of interest in line with our business strategy.
- Provide strategic leadership to develop and implement a comprehensive development strategy for the cannabis/psychedelic portfolio, focusing on achieving milestones.
- Collaborates with related functions including Management, Quality Assurance, Manufacturing and others on the development and future deployment of new molecules and formulations.
- Collaborates closely with customers and other partners to align goals and achieve mutual satisfaction and benefit.
- Provide technical leadership for the design and execution of Quality-by-Design (QbD) product development studies and development of scalable manufacturing process for parenteral drugs.
- Manage Formulation Development for new products. Provide optimized formulations for performance and stability, study material compatibility and evaluate sterilization options.
- Create or enhance market acceptance of the company's products.
- Maintain effective communication with internal and external stakeholders, clients, including investors, partners, and regulatory bodies.
- Present development updates, strategic insights, and risk assessments to the executive team and board of directors.
- Develop and manage the development budget, ensuring optimal allocation of resources to achieve project milestones and strategic objectives.
- Demonstrate strong leadership skills through the supervision, coaching and mentoring of others.
- Responsible for development of scalable manufacturing processes that can be executed in line and related regulatory agencies.
- Support troubleshooting of existing commercial processes as requested.
- Provide data and support for the creation, submission and approval or regulatory documents including, for example, Drug Master Files, IND's, (A)NDA's and the like.
QUALIFICATIONS (Education, Experience, Knowledge, and Skills):- She/he should have at least 15 years of experience and/or knowledge in organic synthesis, process development and enabling technologies.
- Must have relevant industry experience in pharmaceutical/biotechnology small molecule development and/or business development.
- Contract Manufacturing experience (API and Drug Product), drug delivery, and contract research desired.
- Advanced degree (MD, PhD, or equivalent) in a life sciences or medical discipline.
- Proven track record of successful leadership in API, formulation, and product development, preferably within the cannabis/psychedelic area.
- Understand overall drug development process, regulatory guidelines, and CMC strategy in US, with global experience a plus.
- Ability to effectively interact with and influence suppliers/vendors, regulators, global partners or affiliates, industry executives, and trade organizations.
- Must have demonstrated managerial experience in leading a team of scientists, in the areas of R&D, Formulation and Quality preferred.
- Strong analytical problem-solving experience: demonstrated prior experience in leading and motivating teams to conceptualize and develop innovative and creative solutions that are robust and sustainable.
- Preferred: - Experience with Tradeshows/Conferences - Established Industry Connections - Technical Writing Experience
- Ability to prioritize and manage multiple complex situations, where precedent may not have been established; strong decision making and the ability to work through ambiguity and uncertainty.
- Strong presentation skills
- Strong communication and interpersonal skills
WORKING CONDITIONS / PHYSICAL REQUIREMENTS: - Standard office environment.
- Flexibility and ability to multitask and adjust job responsibilities as needed.
- Excellent command of the English language (spoken and written), strong interpersonal skills, and exceptionally strong communication skills.
- Highly effective presentation skills and ability to explain to both a scientific and non-scientific audience.
- Ability to effectively work with other departments and assist as needed as a scientific reference point.
