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Executive Director, Development

Job Title: Executive Director, Development
Contract Type: Permanent
Location: Ireland
Industry:
Contact Name: Gerry Kennedy
Contact Email: gerry@rftgroup.ie
Job Published: 7 months ago

Job Description

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.

Job Spec

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

Qualifications:

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

Skills:

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

Innovative

Self-motivated and adaptable to changing conditions

Well-developed skills of Microsoft Office.

Experience:

 

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

 

Cv to gerry@rftgroup.ie       01 2302400