Executive Director, Development
Our client is a recognized leader in pharmaceutical innovation.
The Executive Director, Development is a member of the Leadership Team and leads the Development Department responsible for development of new pharmaceutical products, new drug delivery innovations and medical device technologies, design, engineering and qualification of new equipment, new processes and new methods related to the manufacturing, scale-up and nonclinical and analytical testing of the Company’s products and new intellectual property.
The Executive Director, Development provides strategic direction and guidance to a full complement of senior managers to ensure the attainment of corporate development goals. The position typically has responsibility for establishing objectives, plans and budgets related to development initiatives and projects and approving contracts, proposals, purchase requests and invoices. The Executive Director, Development has oversight responsibilities for the Development Department to provide technical expert support related to nonclinical and CMC sections for regulatory filings, management of clinical supplies, transfer of methods, processes and equipment to commercial manufacturing and QC functions to support production goals for capacity, cost of goods and process improvements.
Leads Development efforts for new drug product candidates selected for advancement
o Formulation development
o Analytical development
o Manufacturing process development
Strategic oversight of nonclinical development of new and existing products
o GLP safety & tolerability studies
o Production and management of GLP drug supplies
Production and management of GMP clinical supplies & ancillary materials
o Ensure uninterrupted drug supply to patients
o Oversight of IVRS to ensure correct drug assignment & maintaining proper blinding
Responsible for preparation and Executive Management review of nonclinical & CMC documents for regulatory filings
Expand capabilities, robustness, efficiency & ease-of-use of the product
Leads development of innovative new drug delivery technologies
Development of new intellectual property and support for patent filings
Leadership & strategic oversight of manufacturing process improvements, new equipment design & development, qualification, validation and transfer to Commercial Manufacturing
Provide necessary resourcing, planning, organization, prioritization and coordination of the Development activities to meet deadlines and goals
Staff development, hiring, budgeting and cost controls
Member of Development Committee
Member/Chair of Specification Committee
Advanced degree in health sciences-related field such as chemistry, biochemistry, or chemical engineering.
At least 15 years in Pharmaceutical Products leadership with roles of increasing responsibility
Experience in chemical synthesis, drug substance and pharmaceutical drug product and/or biological products manufacturing. Experience in medical devices manufacturing a plus
Demonstrated problem solving and troubleshooting skills
Regulatory Affairs experience, preferably in CMC
Project Management experience
Familiarity with FDA regulations and guidance documents
Demonstrated leadership and matrix management skills
Strong Team leader as well as team player with demonstrated ability to lead cross-functional teams, manage external vendors and contract manufacturing organizations
Strong interpersonal, written and oral communications skills with excellent attention to detail
Ability to function efficiently and independently in a fast-paced, changing environment.
Ability to prioritize and recognize most important aspects of development process
Self-motivated and adaptable to changing conditions
Well-developed skills of Microsoft Office.
At least 15 years in the pharmaceutical or biotechnology industry with experience in leading or managing development and manufacturing projects and coordinating the efforts of cross-functional groups to achieve project goals.
Experience establishing relationships with and managing vendors, consultants, partners and/or collaborators.
Experience preparing regulatory documents, INDs, NDAs & interfacing with Regulatory authorities
NOTE: The new appointee will work closely alongside colleagues at the companies US plant, before transitioning to the company facility in Ireland
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