Description:
You will be tasked with taking a leadership position for assigned studies/projects and developing clinical development plans. You will have responsibility for writing and/or reviewing of all study-related medical documents. Building and maintaining relationships with third-party contacts such as key opinion leaders and study groups. Where appropriate, you will interact with Health Authorities and other regulatory bodies.
Write and review medical documents (e.g. Investigator brochures, clinical study reports, clinical development plans, newsletters, regulatory documents) together with support from other colleagues.
Medical monitoring of ongoing trials, with focus on continuous safety evaluation and investigator communication.
Close interaction with CROs and with clinical colleagues to support studies.
To ensure support for the company's clinical programme/s, work with network of opinion leaders to gain this support from community.
Lead the presentation and publication of data and results from clinical programme.
Work with discovery scientists to select and validate new drug targets.
Work in close proximity to Pre-clinical colleagues to scientifically evaluate date relevant for clinical development programmes.
Interact with Regulatory Affairs experts.
Profile:
Medical Qualification (MD)
Experience of oncology / haematology drug development
Relevant industry experience in the drug development sector is preferred.
European and/or International experience Good network of KOLs and proven expertise in fostering these relationships.
Leadership and managerial qualities must be evident. |