Senior Medical Director/Senior Clinical Scientist (m/f/d)

REFERENCE NUMBER:

473115/1

MY DUTIES:

- You assist the Clinical Science Leader in all areas of project and study planning, evaluation, documentation and medical monitoring, including IND and annual report development, protocol development, medical monitoring for patients in the program and ongoing clinical review for safety
- You will be responsible for all scientific aspects of a study  
- You assist in the timely medically and scientifically sound development of the clinical portions of an integrated development plan (IDP)
- You assist with the quality and timely preparation of all PDC documents submitted for approval
- You ensure GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed within PDC
- You liaise with appropriate departments inside and outside PDC to define the timing of discussion with the FDA and other regulatory bodies on format of clinical NDA and submission issues
- You assist in the preparation of clinical progress reports for regulatory agencies before they are reviewed by line managers
- You ensure correct data interpretation including interim and Final Study Reports before they are approved

MY QUALIFICATIONS:

- Ideally a senior Medical Doctor with medical monitoring experience, in neuromuscular and/or pediatric
- Able to answer medical questions both internal and external and cover the medical monitoring aspect of the clinical trials
- Medical Doctor degree (prefered)
- Profound experience in working in clinical development and medical monitoring
- Experience in Neuromuscular and/or pediatric
- Experience answering and interacting with Health Authorities
- Fluent in English

MY BENEFITS:

- You will work in an international environment

PROJECT INFORMATION:

- One of the biggest pharmaceutical companies of the world
- Maternity leave cover 

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Natascha Hanser

Reference number
473115/1

Contact
E-Mail: [email protected]