Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.
Google Chrome |
Internet Explorer |
Mozilla Firefox |
Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Facilities Engineer
Carlow
Carlow
Project Engineer
Tipperary
Tipperary
Quality Assurance Engineer
Longford
Longford
MES Analyst - IT Manufacturing
Limerick
Limerick
Project Engineer
Republic of Ireland
Republic of Ireland
Compliance Specialist
Carlow
Carlow
Electronic Design Engineer
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
Injection Moulding Engineer
Athlone
Athlone
Maintenance Reliability Engineer
Tipperary
Tipperary
R&D Senior Program Manager
Galway
Galway
Quality Engineer
Galway
Galway
Quality Systems Manager
Dublin
Dublin
Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
Manufacturing Technician
Clare
Clare
Remote Process Engineer - Fill Finish
Republic of Ireland
Republic of Ireland
Quality Technician
Dublin
Dublin
Recruitment Consultant
Wexford
Wexford
Senior Validation Engineer
Dublin
Dublin
Senior Equipment Engineer
Dublin
Dublin
Clean Utilities Engineer
Carlow
Carlow
R&D Manager
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Medical Device Director
Republic of Ireland
Republic of Ireland
Senior QC Associate
Dublin
Dublin
SAP Functional Analyst - Logistics &
Limerick
Limerick
R&D Project Manager
Galway
Galway
CQV Lead
Tipperary
Tipperary
Senior R&D Manager/Director
Dublin
Dublin
Validation Engineer
Cork
Cork
Senior R&D Manager
Athlone
Athlone
Product Development Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
R&D Manager
Galway
Galway
Process Engineer (NPI)
Carlow
Carlow
Injection Moulding Engineer
Athlone
Athlone
Product Development Engineer
Galway
Galway
Specialist Operations Engineer
Tipperary
Tipperary
Product Development Engineer
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Strategic Automation Lead
Waterford
Waterford
Manufacturing Engineer
Wexford
Wexford
QC Bioanalytical Analyst
Dublin
Dublin
Process Engineer
Limerick
Limerick
R&D Director
Galway
Galway
Senoior Specialist - MS&T
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior Validation Engineer
Limerick
Limerick
Engineering Shift Technician
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Electrical Engineer
Limerick
Limerick
Quality Assurance Specialist
Carlow
Carlow
Senior Quality Engineer
Dublin
Dublin
Project Process Engineer
Carlow
Carlow
Senior Electrical Engineer
Galway
Galway
Cell Culture Analyst
Carlow
Carlow
Project Engineer
Roscommon
Roscommon
C&Q Lead
Tipperary
Tipperary
QC Sample Coordinator
Carlow
Carlow
Senior Design Engineer
Dublin
Dublin
Qualified Person
Limerick
Limerick
R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Quality Engineer
Athlone
Athlone
Quality Administrator
Offaly
Offaly
Senior Quality Engineer
Leitrim
Leitrim
Biomedical Engineer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Principal R&D Engineer
Dublin
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
R&D Director
Galway
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Process Support Specialist
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
QC Laboratory Technician
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
QA Manager
Canada
Canada
Process Engineer
Galway
Galway
Technical Transfer Lead
Dublin
Dublin
Qualified Person
Limerick
Limerick
Aseptic Process Lead
Carlow
Carlow
EHS Specialist
Cork
Cork
Senior Design Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Principal R&D Engineer
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Quality Control Technician
Carlow
Carlow
Associate Global Trade Ops
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Microbiologist
Louth
Louth
Senior R&D Engineer
Clare
Clare
Quality Validation Engineer
Limerick
Limerick
Change Control Coordinator
Carlow
Carlow
Senior Operations Engineer
Galway
Galway
Quality Specialist dRP
Dublin
Dublin
Quality Engineer
Wexford
Wexford
QA Engineer
Leitrim
Leitrim
Supply Chain Manager
Dublin
Dublin
R&D Director
Galway
Galway
EHS Specialist
Carlow
Carlow
Senior QC 24/7 Shift
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
R&D Project Manager
Galway
Galway
Associate Quality Specialist
Tipperary
Tipperary
Validation Engineer
Carlow
Carlow
Senior Quality Engineer
Limerick
Limerick
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Quality Systems Specialist
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Clinical Trial Associate
Dublin
Dublin
R&D Engineer
Galway
Galway
Injection Molding Engineer
North Leinster
North Leinster
Quality Manager
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
QA Specialist
Cork
Cork
Senior Quality Engineer
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
Senior Validation Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Manufacturing Engineer
Limerick
Limerick
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Quality Engineer
Athlone
Athlone
Production Operator
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Senior Mechanical Engineer
Dublin
Dublin
Mechanical Design Engineer
Germany
Germany
Process Engineer
Cork
Cork
Production Operator
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Operations Specialist
Louth
Louth
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Project Manager
Limerick
Limerick
Project Engineer
Clare
Clare
Senior R&D Project Manager
Galway
Galway
Quality Control Planner
Carlow
Carlow
QC Bioassay Analyst (shift)
Carlow
Carlow
Senior Validation Engineer
Dublin
Dublin
Principal Process Equipment Engineer
Dublin South
Dublin South
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Project Manager - R&D
Galway
Galway
Senior R&D Engineer
Clare
Clare
Microbiology Manager
Dublin
Dublin
Manufacturing Technician
Clare
Clare
R&D Engineer
Galway
Galway
Aseptic Process Owner Lead
Dublin
Dublin
Quality Technician
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Program Manager
Cork
Cork
Senior Quality Engineer
Leitrim
Leitrim
Biostatistician
Dublin City Centre
Dublin City Centre
Quality Control Technician
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Electrical Engineer
Cork
Cork
R&D Manager
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
Project Enginer
Dublin South
Dublin South
Senior Electronic Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior Design Engineer
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Business Manager (Pharma Chemicals)
Westmeath
Westmeath
Senior R&D Engineer
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Process Development Engineer
Galway
Galway
R&D Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
QA Operations Specialist
Greece
Greece
Senior Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Project Engineer
Limerick
Limerick
Quality Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Laboratory Analyst
Tipperary
Tipperary
EHS Systems Specialist
Carlow
Carlow
Principal R&D Engineer
Galway
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Maintenance Engineer
Cork
Cork
Product Development Engineer
Galway
Galway
Senior Quality Engineer
Leitrim
Leitrim
Engineering Business Manager
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Project Manager - Suite Lead
Tipperary
Tipperary
Maintenance Engineer
Carlow
Carlow
Maintenance Planner
Westmeath
Westmeath
Packaging Engineer
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
Injection Moulding Engineer
Athlone
Athlone
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Injection Moulding Engineer
Leitrim
Leitrim
Senior Quality Engineer
Leitrim
Leitrim
Validation Lead
Dublin South
Dublin South
Principal Software Engineer
Athlone
Athlone
Validation Engineer
Athlone
Athlone
QC Chemistry Analyst (Shift)
Carlow
Carlow
Process Support Specialist
Carlow
Carlow
Manufacturing Engineer
Galway
Galway
QC Laboratory Technician
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
R&D Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Operations Engineer
Galway
Galway
EHS Systems Specialist
Dublin
Dublin
Engineering Projects Lead
Carlow
Carlow
Territory Manager - Scientific (Ireland)
Tipperary
Tipperary
Process Engineer (Shift)
Carlow
Carlow
Product Lead
Dublin
Dublin
Suite Team Delivery Lead
Tipperary
Tipperary
Senior HVAC Engineer
Dublin
Dublin
Validation Engineer
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
Senior Regulatory Affairs
Galway
Galway
Senior Operations Engineer
Galway
Galway
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Senior Associate Quality Control
Dublin South
Dublin South
R&D Program Manager
Dublin
Dublin
R&D Engineer
Galway
Galway
Head of R&D
Galway
Galway
Director of Quality Engineering
Limerick
Limerick
Associate Quality Specialist
Tipperary
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
E&I Turnover Engineer
Carlow
Carlow
Maintenance Engineer
Cork
Cork
Technical Sales Manager (Chemistry)
Westmeath
Westmeath
Chemical Engineer
Tipperary
Tipperary
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Manager
Athlone
Athlone
Apply for this job
Details
Associate Director, Clinical Trial Program Lead
Reference: | SCA013518 | Location: |
Cork |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor
Associate Director, Clinical Trial Program Lead
Our client, a global pharma company, are continuing to grow their Clinical Development and Operations team and are currently recruiting for an Associate Director Clinical Trial Program Lead to join their team on a permanent basis. As Associate Director Clinical Trial Program Lead you will be responsible for exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.
Responsibilities:
- Lead the development of the clinical asset strategy for phase 1 leveraging quality decision making principles
- Understand assigned therapeutic area including trial designs, risks and execution challenges and best practices
- Provide consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications and manuscripts
- Stay up-to-date, be informed & familiar with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices
- Maintains knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions e.g. FHD requirements, detail of operations to deliver critical path studies and submissions
- Lead the implementation and integration of clinical project management processes and tools
- Work with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverables
- Develop and maintain up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team
- Partner with the financial organisation, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process
- Proactively identify and communicate clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates and leadership
- Be accountable and responsible for oversight of clinical trial operations and delivery of clinical project milestones on time, on budget
- Create and manage implementation timeline and clinical trial activities
- Involved in selection process and management of vendors, providing day to day oversight for operational deliverables with external network of vendors to ensure on time and on budget clinical project deliverables
- Be the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward
- Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
- Bachelor’s degree in a science related field
- 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred)
- Strong knowledge of ICH GCP
- Early Phase (Phase 1) experience preferred
- Advanced scientific degree
- Strong leadership and networking skills
- Vendor management and contracting experience
- Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates)
- Ability to influence and oversee TPOs to enable delivery of trial level deliverables
- Demonstrated knowledge and experience with project management tools and processes
- Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships
- Excellent oral and written communication skills; able to communicate clearly and with team members and leadership
Mayo Cork Engineering Dublin Quality Assurance Biotechnology Academic IT Limerick Project Manager Medical Affairs Quality Engineering Microbiology Biopharmaceutical Diagnostics Scientist Quality Control Medical Device Allied Healthcare Supply Chain Supply Chain Manufacturing Executive Product Development Engineer Packaging Engineer Clinical Research Sales and Marketing Laboratory Scientist Pharma Sales PhD Sales and Marketing Cork City Scientific Life Science Connected Health Pharmaceutical Validation Engineer Academic Chemistry
Group sites:
Scientific Jobs | Biopharmaceutical Jobs | Medical Affairs Jobs | Contract Jobs | Chemistry Jobs | Supply Chain Jobs | Engineering Jobs | Medical Device Jobs | Clinical Research Jobs | Pharmaceutical Jobs | Connected Health Jobs | Biotechnology Jobs | Quality Assurance Jobs | Science Jobs
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS