Ambitious Drug Development expansion plans have led to the establishment if this exciting management position. This opportunity offers a rare chance to make a key contribution towards building a successful ambitious young company.
The Director, Drug Development works on directing the 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 appointee will be 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. This position reports to the Executive Director, Drug Development.
The Director, Drug Development will:
- Initiate development programs and be the lead on specific projects.
- Specify the technical requirements for the development program, including performance criteria, materials, analytical methods, test protocols, packages (clinical and commercial) and manufacturing methods.
- Manage 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.
- Prepare, 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.
- The preferred candidate with hold a PhD in Engineering, Pharmacy or science and 6 or more years’ experience in pharmaceutical product development.
- 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
- Experience in a number 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
- Highly organised, with exceptional time management and prioritisation
- Critical thinking/ evaluation of process problems
- Strong work ethic
CV to Gerry Kennedy The RFT Group email@example.com 01 2302400