Associate Medical Director / Medical Director Clinical Development

Recruiter
Axess Ltd
Location
South East England
Posted
02 Dec 2017
Closes
08 Dec 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Key position working as part of the medical team to design, execute and report on pivotal phase II / III EU clinical studies within an ambitious, rapidly growing Biopharmaceutical organisation.

BACKGROUND

- Well-funded specialist biopharma organisation
- Rapidly growing in Europe
- Opportunity to play a key role in the European growth of the company
- Central London location

PRIMARY DUTIES

- Design and execute clinical development plans and protocols for clinical trials
- Provide clinical trials expertise to support to study teams and participate in multidisciplinary meetings
- Medical monitoring of clinical trials and provision of medical expertise to the team
- Contribute to the analysis and discussion of study results
- Author key clinical documents, including protocols and study reports
- Contribute to the preparation of documents required for regulatory submissions
- Contribute to scientific publications
- Ensuring compliance with GCP across clinical trials
- Work closely with Regulatory, CMC, and Clinical Operations counterparts
- Develop relationships with investigators and key opinion leaders of clinical trials to both global and European management and for proactively addressing issues that arise.

QUALIFICATIONS / EXPERIENCE REQUIRED:

- Level and title for the position will be determined by the qualifications and experience of the candidate.
- A Medical Degree combined with industry experience is required.
- Significant experience in the design execution, analysis and reporting of Phase 2/3 EU or Global clinical trial
- Experience of contributing to the clinical sections of a marketing authorisation application
- Experience in immunology preferred
- Thorough understanding of GCP and familiarity with relevant FDA and ICH guidance
- Working knowledge of statistics as applied to clinical trial design and analysis
- Experience in writing and editing scientific research reports

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

Benefits:

Competitive including share options

TO APPLY:

For a confidential discussion please telephone Rebecca Bray at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-6982.

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market