Company: Advanced Clinical Recruitment Ltd
Closing Date: 10 Nov 16
Type: Full Time
Salary (£): Competitive
My client has a broad pipeline of products in development. They are looking for a Head of Pharmaceutical Development to be based in Saint Genis Pouilly, France. This position will report to the Global Head of Research and Development.
The selected candidate will be in charge of the overall operational management and oversight of pharmaceutical development. He/She will work closely with all R&D members as well as Regulatory Affairs, Project Management and the Group Responsible Pharmacist, to coordinate and ensure the successful completion of the pharmaceutical development activities within the agreed timelines and budget, and in compliance with the required quality, Good Manufacturing Practice and ICH Guidelines.
Accountabilities will include, but not necessarily be limited to, the following:
- Oversee and coordinate radiopharmaceutical product development (ready-to-use injectable solutions and kits for radiopharmaceutical preparation).
- Lead a team of pharmaceutical development managers and radiochemists with cross functional project management responsibilities.
- Ensure manufacturing processes and control methods are successfully transferred to the manufacturing sites at full manufacturing scale for supporting clinical development and marketing license approval process.
- Lead contract negotiations with CMOs for API supply, drug product process development and cGMP manufacturing, including API sourcing strategy
- Take part in due diligence activities and represent pharmaceutical development function in licensing-in initiatives and partnership.
- Responsible for the accuracy and reliability of the information generated in the drug development programs, including drug product and API stability testing programs.
- Ensure that the scope of work, planning, training, expectations and timelines are unequivocally understood by all team members and stakeholders.
- Anticipate, recognize and resolve issues proactively with the project team
- Develop / maintain related processes, policies and SOPs.
- Ensure the appropriate communication among all functions within the company and with external vendors.
Professional Skills and Experience:
- PharmD or PhD in Pharmaceutical Sciences, with comprehensive knowledge in injectable products manufacturing.
- Industry experience in (radio) pharmaceutical products development, including radiopharmaceutical kits.
- Strong awareness of GMP standards and drug development regulatory guidelines.
- Hands-on knowledge of analytical chemistry and injectable formulation development, including analytical method development, manufacturing processes and technology transfer.
- Problem solving, creativity and proactivity to implement new approaches and complete product development in full and on time.
- Track record in CMC documentation review and interactions with regulatory authorities for relevant parts of regulatory submission related to pharmaceutical development, including IMPD, IND, CTA, MAA and NDA.
- Highly developed management and communication skills, with experience in working in a matrix organisation.
- Professional proficiency in both spoken and written English.
Personal Skills and Abilities:
- Strong organizational and time management skills.
- Quality oriented with attention to details.
- Highly proactive, self-motivated, professional and dedicated.
- Flexibility and ability to prioritize and manage multiple tasks in a challenging environment.
- Ability to influence and convince key stakeholders in completing pharmaceutical development on time and within budget.
- Excellent English written and oral communication skills; other languages an asset.
- Proficient PC skills: Word, Excel, PowerPoint, email.
- Accept to travel as required.
If you would like to find out more in regards to this oppertunity, please email me via firstname.lastname@example.org.
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