This is an extraordinary exciting opportunity for a technically strong, bright, ambitious drug development scientist. Our client is a young, fast-growing Dublin based pharma company. With a management team who possesses a long history of outstanding business success, this highly entrepreneurial organisation is poised for rapid growth and expansion across its global markets.
The Senior Director, Drug Development works on directing specific technical activities for company product development programs. The activities may be performed by partners, contractors or company personnel. The range of technologies used for products that he/she manage will vary from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, parenteral injectable, as well as possible novel concepts like combination products (i.e. drug-device).
The Senior Director, Drug Development is responsible for overseeing programs from the completion of product feasibility through commercial registration. These programs are typically late stage programs that require flawless execution because they are critical to commercial success. This position has high accountability in both financial and technical decision-making (program direction and development paths). He/ She will also support the transfer of these programs to commercial manufacturing sites. Projects under the stewardship of the Senior Director will be managed out of the Dublin with the potential to extend managerial responsibility to similar developmental projects emanating from the sister site in the USA. This position reports to the Vice-President, Research & Development.
The Senior Director, Product Development will:
- Initiate development programs and provides strategic direction to technical teams.
- Acts as liaison between R&D and Commercial Operations to ensure new products are launched on time and adhere to corporate objectives and goals.
- Harmonizes business processes across the technical organization implementing best practices accordingly.
- Communicates with senior management and site leaders to identify and resolve any technical issues.
- Specify the technical requirements for the development program, including performance criteria, materials, analytical methods, test protocols, packages (clinical and commercial) and manufacturing methods.
- Direct ongoing technical programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt.
- Review/Approve, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND and NDA filings for the products that they manage.
- Assist other department team members in reviewing documents on other projects (protocols, reports, regulatory filings, specifications and the like).
- Support Manufacturing to ensure a smooth transfer of technologies and products to commercial manufacturing sites.
- Create intellectual property covering Pharmaceuticals products.
- Responsible for insuring that training and development programs for staff members are in place to meet future objectives of the business. Participates in Talent Management, succession planning, and talent acquisition.
- The preferred candidate will hold a PhD in engineering, Pharmacy or related science discipline and 12 or more years’ experience in pharmaceutical product (Formulation/process development) development, with a minimum of 6 years’ experience successfully managing teams.
- Direct experience of pharma development, QbD and target product profiling. Drug delivery of sterile and oral product would be preferable, along with drug product device combinations technologies.
- Direct experience with generating documentation for CMC regulatory filings for pharmaceutical products.
- Broad exposure to multiple pharma technologies and knowledge of standard dosage forms.
- Broad understanding of open label pharmacokinetic (phase one type) studies
- General experience of clinical trials
- Proven project management skills for technical programs.
- Excellent communication skills and strong interpersonal skills.
- Flexibility to travel on company business when required (estimated 20% Travel)
- Experience in the direct development of the following is desired: solid dosage forms, controlled release formulations, combination products, parenteral products, long acting injectable, API manufacturing, and analytical chemistry.
- A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity
- Experience working with contract manufacturing & research organisations.
- Highly organised, with exceptional time management and prioritisation
- Critical thinking/ evaluation of process problems
- Strong work ethic
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