P2305 - Clinical Scientist
vor 9 Stunden
Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
For our Clinical Development organization based at our Headquater in Lausanne, we are looking for a
Clinical Scientist
The Clinical Scientist provides scientific expertise to the design and delivery of Global clinical studies and programs for innovative new medicines.
He/she works in close collaboration with the Medical Director Oncology and cross-functional clinical study teams to deliver high quality study data and analyses
**Your responsibilities will be but not limited to**:
Design and execute assigned clinical trial
Work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical trial
Contribute to development of end-to-end clinical development strategy
Protocol development with mínimal guidance (writing, reviewing, resolution of cross functional comments)
Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
Monitor, review and interpret safety and efficacy data of ongoing clinical trials
Act as (clinical science expert) liaison to cross-functional project core team, clinical study teams, CRO's, study sites and others
Establish relationships with investigators, KOLs, partners and appropriate consultants
Provide clinical scientific input to business development (e.g. due diligence) and marketing activities
Perform literature research
Develop and deliver presentations to internal and external stakeholders. Provide input in scientific communication plan and scientific publications
**Requirements**:
Master's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, MSN, MPH, etc.)
Experience in conducting Clinical Studies in Oncology
5 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols
Broad experience in the principles and techniques of data review, analysis, signal detection, interpretation and clinical relevance
Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations
knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end-results.
Driven and proven abilities to perform responsibilities independently and with limited guidance
**Excellent project management skills**: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget delivery. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
Strong interpersonal, verbal/written communication, negotiation and influencing skills in English
**Proven track record of effective decision-making**: makes good business decisions and exercises sound judgment
**Proven teamwork skills**: has a proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams. Demonstrate curiosity and challenge status-quo
**Benefits**:
International, highly dynamic environment with a long term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
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