Non-Clinical Development Project Manager

Location
Berkshire
Salary
Competitive
Posted
21 Jul 2017
Closes
18 Aug 2017
Ref
J4194
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
We currently have an exciting opportunity available for a Non-Clinical Development Project Manager to join a growing pharmaceutical company based in the Berkshire area.

As the Non-Clinical Development Project Manager you will be responsible for planning and managing all non-clinical (pharmacology, toxicology, DMPK, bio-analysis and environmental risk assessment) activity associated with the development and first registration of products within the R&D portfolio (NCEs, new drug / device combinations, etc.).

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Non-Clinical Development Project Manager will be varied however the key duties and responsibilities are as follows:

1. Prepare and execute plans to deliver the non-clinical strategy for assigned development projects.

2. Schedule and coordinate appropriate GLP & non-GLP studies to enable the timely progression of products through clinical development to achieve registration.

3. Select contract research organisations and manage relationships, milestones and budgets. Monitor the outsourcing, conduct and reporting of studies and ensure the compliance of CROs with GLP as appropriate and that high scientific standards are met.

4. Provide regular progress and data summary updates to assigned cross-functional project teams and other internal/external stakeholders as required.

5. Coordinate the execution and delivery of non-clinical studies requested by the business to support lifecycle management / maintenance of licences for registered products.

6. Ensure non-clinical written and tabulated summaries are prepared to support PIP, IMPD, CTA, IND, MAA and NDA submissions and approvals.

7. Liaise with regulatory authorities and assist in the provision of answers to requests for non-clinical information

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Non-Clinical Development Project Manager we are looking to identify the following on your profile and past history:

1. Degree in Biology, Pharmacology or other appropriate scientific discipline, plus extensive knowledge of non-clinical study / data requirements (including ICH guidelines pertaining to GLP studies) to support new product registrations in global markets.

2. You will be required to demonstrate experience creating, managing and maintaining effective working relationships with CRO / vendors of non-clinical studies.

3. Confident and effective communicator with excellent oral, written and presentation skills. Able to exercise effective decision making and sound judgement. Possesses demonstrable problem solving skills. Able to manage multiple activities to agreed deadlines. You will require excellent negotiating and influencing skills.

Key Words: Non-Clinical Development | Project Manager | Non-Clinical Study | Pharmacology | Toxicology | DMPK | Bioanalysis | Contract Research Organisation | GLP

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.