Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving 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. Bridging the gap between disruptive discovery products and real-world patient reach, we 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.
Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.
For our Clinical Development organization based at our Headquater in Lausanne, we are looking for a
Senior Clinical Scientist, Oncology
The Senior 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 minimal 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
- 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
- An international and highly dynamic environment, with a long term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.