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 young company.
The Director, Drug Development works on directing the technical activities for company product development programs based out of the Dublin office. The activities may be performed by partners, contractors or company personnel at various global locations. The range of technologies used for products that he/she manage will vary from standard pharmaceutical dosage forms to parenteral injectables, sustained/controlled-release dosage forms, as well as drug-device combination products.
The appointee will be responsible for overseeing programs from the completion of product feasibility through process development, scale-up and registration in commercial manufacture. These programs are a mix of early-stage proof of concept, through IND, as well as late stage and life cycle management 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 Senior 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, control strategies, materials, analytical methods, test protocols, specifications, packages (clinical and commercial) and manufacturing methods.
- Manage remotely 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.
- Drive Innovation and proof of concept activities.
- 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 pharmaceutical development, QbD and target product profiling. Experience with sterile parenteral and sustained release products would be preferable, along with drug product device combinations technologies (pre-filled syringes, autoinjectors, etc)
- Direct experience with authoring, reviewing and compilation of documentation for CMC regulatory filings for pharmaceutical products to both the US and EU.
- 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 IND and clinical trials
- Experience in a number of the following is desired: solid dosage forms, controlled release formulations, combination products, parenteral products, sustained release products, implantable and biodegradable products, API manufacturing, and analytical chemistry.
- Experience working with and directing remotely contract manufacturing.
- Proven experience of remotely managing a technical team.
- Proven project management skills for technical programs.
- Excellent communication skills and strong interpersonal skills.
- Flexibility to travel on company business when required.
- 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.
- Highly organised, with exceptional time management and prioritisation
- Critical thinking/ evaluation of process problems
- Innovative mindset and understanding of intellectual property generation.
- Strong work ethic
CV to Gerry Kennedy The RFT Group firstname.lastname@example.org 01 2302400