Reference Number: JO-2204-490632
Drug Safety Director
Job Type: Permanent
(Senior) Drug Safety Director start up Biotech
CPL Life Sciences has partnered with a truly innovative, start up Biotech, in search of a Drug Safety Director.
The company is focusing on developing revolutionary technology to combat immunologic diseases. With very strong & positive data collected so far during clinical trials, they are now looking to make their first hire within PV to help support the companies vision and pave the safety strategy going forwards.
As you can imagine, working within a start-up environment can be challenging; requiring a leader who is hands-on, willing to take on responsibilities that are perhaps outside of the job description but also someone who is able to lay the foundations for the PV department.
Chair the safety committee
Manage and provide oversight to all vendor related activities
Hands on PV activities: signal detection, aggregate reporting, risk management, regulatory filings, developing key safety documents (SMPs, DSURs)
Provide advice and guidance throughout clinical development programmes
Act as the Medical Director (if MD qualified)
MD or Physician preferred or a degree in a life sciences related discipline
Experienced in clinical safety. Ideally involved in early stage clinical development programmes
Strong experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
Experience in producing safety documents
Good knowledge of safety databases
Able to work 99% from home with occasional trips to the office each month
If you are interested in working within challenging environment, with a fantastic team and innovative tech then reach out to Andrew Linskey using Andrew.email@example.com