Clinical Research Scientist

vor 2 Wochen

Lausanne, Schweiz agap2 - HIQ Consulting Vollzeit

Founded in 2005, agap2 is a European company of engineering andoperational consulting. We operate in the sectors of Energy, Infrastructure,Transport, Chemistry, Life Sciences and IT.

Today, the agap2 group has a team composed of over 5000 qualifieddoctors and engineers. We work on projects around the world from ouroffices in Europe - Switzerland, Germany, Belgium, Spain, France,Netherlands, Portugal, and UK.

We attach as much importance to the spirit, ambition, dynamism, anddaring as to the expertise of our teams. Attached to these basic humanvalues, we recruit high-value profiles to strengthen our technical teams andour industrial partners in Switzerland (offices in Basel, Zurich and Lausanne)

Tasks

You are responsible for medical and scientific contribution to: protocols, new product and indication opportunities, drug safety, study reports, IBs, regulatory submissions, manuscripts, medical education, and other projects requiring medical/scientific research, analysis, evaluation, training and reporting.

In collaboration with a cross-functional team, contribute to the development of effective and innovative clinical trial designs, and facilitate execution of clinical trials by supporting site and CRO personnel, safety monitoring activities, data clean-up activities, data analyses, and clinical study report development and finalisation
- Author protocols, and provide scientific input into manuscripts/publications, IBs, regulatory and clinical study reports
- Research and analyse scientific/medical information and data with respect to clinical trials, safety databases, and other medical/scientific elements necessary for decision-making and regulatory submissions
- Assess safety data including labs and SAEs on an ongoing basis for ongoing clinical trials; manage DSMB processes for clinical trials
- Provide Medical Oversight and Medical Monitoring to interventional clinical trials (supported by CROs, if applicable)
- Contribute to Clinical Development Plans of projects within the OM Pharma Pharma project portfolio
- Maintain and evaluate current knowledge of key disease areas, providing information to appropriate groups as needed
- Serve as a deputy of the Head of Clinical Development as needed
- Evaluate investigator-initiated study protocols and make recommendations (if applicable)
- Prepare and present medical education materials, medical/scientific materials at investigator meetings, internal training materials with respect to medical/scientific issues
- Medical/scientific training for internal staff, service providers, investigators and others as needed

Business travels are required for this position, around 5-10% of working time.

**Requirements**:
**Minimum Requirements**:

- PhD, PharmaD or master’s in science/health-related discipline
- Minimum 5 years pharmaceutical industry experience
- Knowledge and experience of clinical trial design, data analysis, statistics, and researchmethods
- Knowledge of the drug development process and clinical research methodologies
- Ability to work independently and in a fast paced, hands-on, flexible, dynamically changing environment
- Trained in GCP regulations, and familiar with ICH and FDA guidelines relevant to clinical development
- Proficiency in MS Office
- Business fluent in English and French

**Preferred Requirements**:

- Knowledge and experience in immunology and/or infectious disease clinical trials desired
- Experience in writing and submission of Health Authority documents (e.g., BLA, NDA, MAA) desired

Applications from Switzerland and EU only will be considered.

**Benefits**:
**What “being an Agapian” stands for**:

- being an expert in a fast-paced and diverse environment
- joining an organically fast-growing company
- working in an agile company with startup feeling
- joining a team guided by shared values, respect, trust and fun
- meeting wonderful people and their network
- facing technical challenges in changing industries
- chance to speed up and improve your career
- having choice of projects, follow ups and trainings
- being valued and not just one of many

Looking for enthusiastic, flexible and dynamic leaders of tomorrow

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