Job Summary

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 relationshipsdrive 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.

 

Essential Responsibilities

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

Scientific excellence

·        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

·        Maintain the highest quality of scientific inquiry supporting CURE’s drug formulation and development process

Job Requirements

Education:

·        Masters Degree in relevant disciplines pertaining to drug development (or equivalent with work experience); PhD preferred

Experience:

·       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.

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