Senior Clinical Scientist
Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Medicine Service, Clinical Research & Development Department based at our Headquater in Lausanne, we are looking for a
Senior Clinical Scientist
The senior clinical scientist develops promising Debiopharm molecules into medicine that fulfil patient's needs and provides them with the best value. He/she works in close collaboration with the Medical Director and cross-functional clinical study teams and provide clinical science support for assigned programs.
- Drive development of clinical development plans and protocols for clinical studies;
- Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);
- Monitor, review and interpret safety and efficacy data of ongoing studies;
- Represent clinical R&D in cross-functional project core teams;
- Serve as clinical expert in communications with Regulatory Authorities worldwide;
- Act as (clinical science expert) liaison to clinical study teams, CRO's, study sites and others;
- Participate in cross-functional clinical study team meetings;
- 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 as needed;
- Develop and deliver presentations to internal and external stakeholders.
- Master's Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, MSN, MPH, etc.).
- Experience in Oncology and/or Infectious Diseases is a plus.
- 5+ years of relevant experience in clinical development within the pharmaceutical industry.
- Data listing review experience. Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance.
- Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation), FDA, EMEA and other relevant guidelines and regulations
- Has 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 has 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. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
- Strong interpersonal, verbal/written communication, negotiation and influencing skills.
- 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.
- Ability to travel (<20%).
Debiopharm International can offer you
- An international and highly dynamic environment.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application.
For more information : www.debiopharm.com