Associate Director role, with excellent benefits. Early phase clinical programme development.
Permanent new role in a growing pharma company in the South-East UK.
Haematology or gene therapy experience a requirement.
If you^are ready to take the next step in your career in drug development, this role is for you. If you are the right person, you will be ready to lead a clinical development programme for a key molecule, brought in to our client by acquisition. You will^understand the risks in early development and will be able to demonstrate that you have previously dealt with such risks and delivered a successful programme in to Phase III and ideally, a product to the market.
This role has been open through CSL^before, and previous applicants cannot be considered.
Lead the clinical team to develop and deliver the clinical development plan
Provide input into the development strategy of the product and to the development of the clinical development plan
Create alternative scenarios and risk benefit analysis to make recommendations to align with therapeutic and corporate strategies;
Oversees protocols, ICFs, sections of Investigator Brochures and oversees study report writing;
Oversees the selection, management/oversight of CRO activities and other clinical vendors to ensure quality is consistent with requirements;
Coordinates the on-schedule delivery of clinical trial supplies in collaboration with the development team and appropriate use of IVRS/IWRS
Responsible for planning/support of planning of investigators' meetings and may present information at the meeting to familiarize investigators with the protocol and monitoring procedures
Responsible for management /oversight of clinical monitoring of research studies, which includes production and approval of a Clinical Monitoring Plan;
Develops/reviews budgets for clinical development program and negotiates budgets and contracts with CROs and investigative sites.
Essential Skills & Qualification
Bachelor's degree or nursing qualification is required. Scientific/health care field preferred
Detailed clinical research experience with evidence of increasing responsibility within a pharmaceutical company or CRO or similar organization.
Experience of regulatory submissions is desired.
Knowledge of current regulatory requirements and guidelines governing clinical research
Demonstrated delivery of an international clinical development programme from^within a European setting
Knowledge of haematology and / or gene therapy
Software Competence: MS Office, MS Project
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel:^Yes
Flexible Working Hours: No
Employer: Pharmaceutical Company
Hours: Full time
Location: UK; Hampshire
Plan Start Date: Nov 2012
Company Pension, Company Car, Car Allowance, Life Insurance, Private Healthcare, Dental Care, Flexible Package Plan, Stock Options/Purchase Plan, Bonus, Free gym, Free Bus, Childcare Vouchers. Relocation Assistance.
Clinical Research, Clinical Operations, Clinical R&D,^CRA, CTM, , GCP, Manager, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme,Feasibility, CRO Manager REC, Research Ethics,Site Manager, Outsourcing
Assigned Consultant: Avril Horn at CSL Recruitment on 01932 234686
Please feel free to call for a detailed Job Description or additional information