Purpose of role
Clinical Safety expert within the Drug Safety Team at MRL who provides safety oversight and expertise to the clinical development programs.
Key Responsibilities – Strategic, Financial, Resource, Management, Decision Rights, Key interactions (Internally / Externally)
- Responsible for strategic clinical safety input and delivery to all asset development activities across a variety of therapeutic areas including oncology.
- Responsible for clinical safety support for Due Diligence.
- Responsible for overseeing clinical safety vendor(s).
Tasks that individual will carry out:
- Set the strategic direction for delivery of clinical safety services provided to the Mundipharma companies and their licencing.
- Deliver effective clinical safety strategy for our clinical development pipeline, including successful risk management and signal management activities.
- Ensure the safety of patients in our clinical development programs through optimal clinical safety monitoring.
- Provide Clinical Safety expertise to the entire R&D and work closely with Clinical Development on the development of the safety relevant GCP compliant key trial documents such as trial protocol, IB, SMP.
- Ensure effective and efficient clinical safety support for the evaluation of potential new development opportunities.
- Vendor oversight for outsourced clinical safety tasks, which include case processing, medical assessment and regulatory reporting.
- Development of Safety Management Plans.
Key Skills and experience required:
- Demonstrated experience as a safety physician in the Pharmaceutical or CRO industry.
- Experience with clinical safety in Phase 1 to Phase 3 trials.
- Experience of working across a global development programme.
- In depth knowledge of clinical safety regulatory requirements and industry best practices.
- Demonstrated knowledge and experience of provision of successful Clinical Safety strategy and services.
- Strong negotiation and problem-solving skills.
- Excellent communication skills and ability to engage with Senior Leaders within the organisation effectively.
- Strong focus on the meeting the needs of our Stakeholders and Customer.
- Medical Doctor with demonstrated industry experience.