Clinical Research Physician

Clinical Research Physician

Bial

Porto, Portugal

The Impact You’ll Make

• Design and/or review the clinical study protocol outline and support the clinical development plan;
• Participate in the preparation and medical review of clinical documentation related to new or ongoing clinical studies;
• Support the clinical research and operations team and provide the medical oversight of the clinical studies (Phase I to IV);
• Supervise safety within clinical studies, working closely with the Pharmacovigilance team;
• Collaborate in various scientific publications and meetings related to clinical development;
• Analyse study documentation and data in the preparation of clinical study reports;
• Interact with investigators, KOL’s, external consultants and other relevant medical entities in relation to clinical studies or other ongoing projects;
• Analyse and respond to clinical studies medical questions internally and externally (e.g. authorities);
• Provide medical support in due diligence activities;
• Provide scientific & medical support and guidance to the operational teams (as per projects) and to other internal stakeholders (e.g. pre-clinical research, business development, regulatory, etc.);
• Comply with good clinical practice and/or SOPs;
• Comply with the Quality, Environment, R&D, Health and Safety Policies, Standards and Procedures;
• Participate in other department activities, as needed.

What You’ll Bring

• Degree in Medicine;
• International experience within neurosciences area (preferred);
• Knowledge of ICH/GCP regulations, FDA and EMA guidance documents, drug development process and clinical monitoring procedures;
• Good communication and team-work skills, ability to multi-task;
• Excellent organizational and time management skills, able to prioritize workload to meet deadlines;
• Autonomy, results oriented and proactivity;
• Availability to travel.

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