ATMP Expert [Associate Director, Director]
Reports to: Technical Director
Based at: Dependent upon experience and on the profile of the candidate. Located at a Diamond Office in the UK or The Netherlands is preferred
The ATMP Expert provides development stage advice to internal staff and to clients for a broad range of Cell and Gene Therapy programmes. They will possess a strong understanding of existing and leading-edge technologies, and is able to speak knowledgeably about client programmes. They will provide the following expertise based services:
- Write IMPDs / INDs and quality related documentation for clinical development programmes.
- Advise strategies to ensure the progression of compliant clinical programmes leading into and throughout all stages of clinical development.
- Provide expert advice on matters related to genetically modified organisms.
- Implement robust CMC compliance programmes covering all aspects from monitoring changes to manufacturing processes, vector design, specifications and shelf life maintenance.
- Is a point of contact for agency interactions and negotiates pragmatic solutions during grounds for non-acceptance and throughout the duration of clinical studies.
- Leads technical based discussions during scientific advice with National Agencies, the EMA, and FDA (including endo of Phase 2 meetings).
- Leads interactions with contract manufacturing organisations, contract research organisations and/or the technical teams within client organisations to extract data and guide activities to deliver a compliant programme that meets regulatory expectations.
- Attends and presents at specialist ATMP focussed conferences.
General Responsibilities and Duties of the Dept
Diamond BioPharm Limited is the Regulatory function within Diamond Pharma Services. The function provides end to end regulatory services and expertise driven product development advice from early stages of development through to post market support. Our regulatory division are experts in all aspects of European regulatory affairs providing support to clients in the following areas:
- Writing product development plans and providing gap analysis
- IMPD/IND writing
- Technical CMC support
- Preparing orphan applications, PIPs and PRIME submissions
- Assisting with scientific advice procedures
- Clinical Trial Application submissions
- GMO applications
- Ethics submissions
- Assistance in preparing and submitting variations and Marketing Authorisation Applications through the various Regulatory Authority procedures
- Acting as an overflow Regulatory Department
Key Responsibilities and Duties of the Role
- Provide world-class advice across a range of cell and gene therapy product types
- Expert IMPD / IND and Module 3 dossier writer
- Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
- Provide development related strategy for a broad range of programmes
- Provide ATMP advice and dossier support for US based programmes
- Regulatory lead and point of contact for national agency and EMA interactions
- Provide direct line management and matrix team based leadership where needed
- High level of client focus and accountability
- Assist with Business Development activities by taking part in new prospective client-lead discussions
- Degree or higher in Biology, Genetics, Molecular Biology, Pharmacology, Chemistry, Biochemistry, or related scientific disciplines
- Experience in leading cell or gene therapy development programmes
- Prior experience in agency interactions and providing technical expertise in discussions with regulatory assessors
- Demonstrable experience in contributing to regulatory dossier content, IMPDs and INDs for ATMP programmes
- Collaborative approach and able to work effectively with matrix based teams
- ATMP expert, able to provide clear advice in discussions with clients and their partners, including contract manufacturers, contract research organisations and the technical teams within client organisations
- >5 years of experience in clinical stage ATMP programmes
- Confident speaker about the advance of ATMP technologies, their challenges, and potential solutions
- >10 years of relevant experience in ATMP development
- >5 years of experience in regulatory affairs based activities and regulatory authority interactions
- Experience of technology transfer, analytical development, and process development.
- Exposure to MAA dossier writing and submission procedures
- US FDA facing experience
- Innovative and pragmatic problem solver
- Attention to detail
- Strong communicator with the ability to influence
- Completer-finisher able to provide decisive leadership in a project team setting
- Ability to provide a flexible, proactive and dedicated approach whilst dealing with clients with different working styles and cultures.
- Strong client focus