Responsibilities of the Safety Responsible Physician (Experimental Medicine Neuroscience)
The Safety Responsible Physician in Experimental Medicine Neuroscience is a responsible member of the clinical team and safety management team dedicated to the development, implementation and execution of the medical/safety strategy of a complex compound program in early development. The Safety Responsible Physician provides active medical and scientific contribution to a cross-functional clinical team for each project assigned in early development. The Safety Responsible Physician provides medical/safety input to the clinical development plan, the clinical trial protocol, and clinical trial materials. The Safety Responsible Physician is responsible for the medical monitoring and safety reporting activities for each assigned project. The Safety Responsible Physician may be asked to contribute to the evaluation of scientific opportunities in the neuroscience therapeutic area.
- Responsible for all medical and safety aspects for each assigned neuroscience early development study, project or compound
- Responsible for medical monitoring/reporting and evaluation of adverse events in early development clinical trials
- Be the liaison between clinical team and investigational site for any safety related aspects
- Provide safety/medical interpretation and reporting of clinical research results
- Takes responsibility for the on the safety/medical aspects of the clinical development plans, trial protocols and clinical study reports
- Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting in relation to any safety/medical aspect.
- May act as a medical contact at the company for health authorities concerning clinical/medical issues
- Close interactions with Clinical Leaders and Clinical Scientists across studies and programs.
- Develop, review and coordinate the safety review procedures, policies and activities within Experimental Medicine Neuroscience
- Helps explore and evaluate new compound/study ideas.
- Assess external clinical research proposals from a safety perspective which may involve Janssen products (marketed or in development), in concert with the clinical leader and clinical scientist
- May be asked, if appropriate based on experience, to take on Clinical Leader responsibilities for assigned early development projects
- May be asked to assess medical publications emerging from the Team and its affiliates
Profile of the Safety Responsible Physician (Experimental Medicine Neuroscience)
- You are a physician and have at least 8 years of relevant experience
- Experience with clinical studies – phase 1
- experience with evaluating safety and with translating animal tests to human tests
- Fluency in Dutch and English is essential
Offer for the Safety Responsible Physician (Experimental Medicine Neuroscience)
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees