Clinical Expert

Our Client is passionate about globally being the preferred partner in pain management for patients, healthcare professionals and payors. The corporation drives innovation to expand European market leadership in moderate to severe pain. Our Client is an independent, family-owned German corporation with companies in 34 countries all over the world. Founded in 1946, the corporation employs 2,000 people in Germany and 5,200 worldwide. In 2008, our Client achieved revenues of about 864 million Euros.

Together with highly specialised partners they are pressing on with the research and development of new active substances. For this they are concentrating on selected indications and the latest technological developments. They are intensively searching for innovative ways of improving pain management, pain relief and reducing side-effects.

The Company has embarked on a far-reaching restructuring with a new CEO and several new Department Heads bringing new and updated processes and procedures into the Company. These key roles are reporting to the Head of Clinical Experts or respective Head of Therapeutic Area and International Clinical Project Leader (ICPL).

The main responsibility of the Clinical Expert is to provide scientific input in the clinical development of assigned compound/s at the scientific/medical level, the clinical project level and the trial level.

Scientific/medical level:

• Assessment of preclinical and clinical investigations
• Scientific evaluation of trial methodologies
• Scientific/medical input to concepts and documents within the pain/analgesia therapeutic area or CNS indications, e.g. Clinical Feasibility Assessment, Clinical Development Plan, the Investigators' Brochure, the Advanced Protocol Synopsis, clinical trial applications, evaluation of potential license candidates and dossiers for registration
• Scientific/medical input to and participation in working groups / advisory boards / expert panels, etc.
• Literature studies
• Attendance at congresses and other scientific forums
• Contribution to publications.

• Participation in meetings with regulatory authorities
• Input to project, regulatory and submission documents as defined in the clinical project processes and team description of the Clinical Core Team Input to potential license candidates as defined in the clinical project processes and the team description of the Clinical Core Team
• Contribution to other activities of the Clinical Core Team as defined in the team profile.

• Discussion of trial aims and design with experts
• Scientific/medical input to the trial, incl. generation of a trial design, protocol synopsis and trial protocol, statistical analysis planning, reporting of trial results
• Scientific/medical supervision of trials, e.g. safety (together with Drug Safety), co-monitoring etc.
• Trial-specific scientific and medical instruction of CSMs, CTAs, CRAs and Investigators assigned to a trial
• Contribution to other activities of the Study Team as defined in the team profile.

• Medical Degree or PhD in Life Sciences
• Fluency in English
  Industry-specific knowledge
• Experience in clinical development within the pain/analgesia therapeutic area or CNS indications
• Relevant scientific knowledge and competence
• Understanding of drug development
• Appreciation of the issues and challenges faced in developing products for therapeutic use
• Experience in interacting with regulatory authorities is beneficial
• Organize work in a structured fashion with attention to detail and compatible with other activities in the clinical project and / or trial
• Strong communication skills
• Ability to work in a team setting
• International and intercultural work experience.

How to apply for the Clinical Expert role:

1. Click the button below to raise an email form
2. Attach your CV file to the email
3. Add any covering letter / personal notes to the body of the email
4. Send your completed job application through to us for processing.

Alternatively, for a confidential discussion concerning the Clinical Expert opportunity you can telephone Robert Bates on +49 (0) 69 219 776 0. Please be sure to quote 10307 in all correspondence relating to this role.