The Director of Product Development is responsible for leading research and product development operations in support of CURE’s growth targets. S/he will oversee the product development pipeline, manage client and vendor relationships, drive innovation and serve as a key member of the leadership team. This position requires exercising independent judgment to perform the responsibilities described herein. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by the employee.
Leadership and strategy
· Inform CURE’s strategy as it relates to formulation science and implement the strategy tactically by overseeing Cure’s research and product development organization
· Provide other members of the leadership team with continuous scientific input to inform business development, clinical development, commercialization, financial planning and execution, regulatory matters and manufacturing.
· Translate Cure’s science into understandable concepts for investors, partners, and other stakeholders.
· Working with the CSO to establish goals and budgets, make policy and infrastructure decisions for the product development department
· Lead cultural and organizational change and implement operational excellence for continuous improvement of competitiveness and financial performance
Operations and management
· Implement the appropriate team and departmental structure and establish the required processes and communications to enable the department to effectively deliver on all commitments
· Responsible for talent management (development and retention) in Product Development department
· Establish and manage a GMP laboratory, oversee the selection and management of CROs and bioanalytical laboratories supporting CURE’s development programs
· Provide exemplary overall scientific and operational leadership in identifying, evaluating, and developing new drug formulations
· Provided and implement regulatory guidance as it relates to product design development and evaluation.
· Participate in authoring and coordinating regulatory documents as needed.
· Develop and execute an aggressive intellectual property protection strategy
highest quality of scientific inquiry supporting CURE’s drug formulation and
· Masters Degree in relevant disciplines pertaining to drug development (or equivalent with work experience); PhD preferred
· Minimum 10 years of experience in basic and applied research and development in pharma and/or biotech.
.Knowledge, Skills and Abilities:
· Robust product development experience with successful track record of leading programs resulting in FDA approval
· High proficiency in QbD both in design and full execution (sanitized real examples are required).
· Preference for oral/liquid solid dosage forms with small and large molecules.
· Solid knowledge of FDA and cGMP regulations
· Solid knowledge and proven experience in creating and securing IP
· Overall business understanding including experience in business development and licensing contracts
· Strong results driven personality, high level of enthusiasm and energy
· Strong networking skills with experts in academia and industry: record of maintaining and developing successful relationships with opinion leaders and investigators
· Fiscal responsibility: ability to facilitate commercial return from research and development investments
· Strong ability to multi-task and to handle multiple programs and portfolios in drug discovery and development
· Leadership and mentoring capabilities and strong interpersonal skills
· Strong communication skills
· Excellent judgment and decision-making capabilities
· Flexibility to acquire additional competencies and skill sets as mandated by the changing needs of the organization
Requires up to 20% travel mainly but not limited within the USA.