Proclinical are recruiting a Medical Director for a biopharmaceutical organisation. This role is on a permanent basis and is located in Cologne.
As a Medical Director, you will provide medical input and scientific advice for projects. Furthermore, you will successfully design, conduct, and report international clinical trials in the respective subject area in collaboration with the project team, external consultants, service providers, and ethical / regulatory bodies.
You will be reporting to the Chief Medical Officer.
Responsibilities:
- Provide clinical and medical input (e.g., regarding unmet needs, translatability into patients or feasibility) at any stage during the R&D-value chain.
- Responsible for the translation of research projects into clinical trials to prove the value of projects.
- Development of the clinical part of the project development plan for a compound.
- Development of clinical trial protocols and provision of clinical input in the conception of CRFs (paper or electronic).
- Creation of the trial reports, critical review and quality checks of the clinical data.
- Development of the clinical part of the investigator brochure, specifically the risk benefit section, information to the investigators and reference safety information.
- Clinical trials: Responsible for medical monitoring, medical input, online follow up of patient data, AEs and SAEs follow up, narratives, participation in the preparation of statistical analysis plan and tables, figures, and listings.
- Interaction with investigators, coordinating investigator and the key experts, e.g., investigator meeting presentations, monitors training, regular contacts with investigators and experts. Establishment of and working with DSMBs.
- Overall supervision of the trial conduct in close working collaboration with the Clinical Trial Manager.
- Development of the clinical part of regulatory documents, e.g., briefing books, summary documents, answer questions to authorities.
Key Skills and Requirements:
- MD degree and holds a license to practice medicine.
- At least 5 years proven experience in running clinical trials specifically Phase II and Phase III trials in the pharmaceutical industry or with international CROs.
- Good understanding of the pharmaceutical value chain and experience in clinical development.
- Experience in running anti-infective clinical trials would be preferred.
- Experience in the translation of research projects into clinical trials ideally in the anti-infective or related indication fields.
- Previous experience in working as a treating physician in a hospital setting.
- Ability and experience in working as a team, e.g., in-house, with CROs, experts and opinion leaders.
- Openness and respect for diversity.
- Leadership, interpersonal communication, organizational and presentation skills.
- Results oriented, capable of setting priorities and managing high workload at times.
- Small biotech mentality and flexibility to accept and perform the tasks of his/her direct reporting workers and colleagues across projects in case of need.
- Fluent in business English and speaking in German would be beneficial.
If you are having difficulty in applying or if you have any questions, please contact Kain Rix at +44 203 854 262... [Vollständig anzeigen] .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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