Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments.
Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-wide marketing and sales.
For our Clinical Development organization based at our Headquater in Lausanne, we are looking for aSENIOR CLINICAL SCIENTIST ONCOLOGYThe senior clinical scientist contributes in developing 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 Oncology (MD Oncology)and cross-functional clinical study teams.
The senior Clinical Scientist provides clinical and scientific support for assigned programs, in compliance with Debiopharm processes, and ICH GCP.
Develop medical and scientific section of study protocols, informed consent forms and other relevant clinical documents (e.
g. SAPs, IDMC and SMC Charters, CRS) in close collaboration with the MD.Contribute to the clinical section of the regulatory / submission documents (e.
g. CTA, IND, BLA, MAA, IB, AR, medical narratives) Contribute to the implementation of the data review plan and data review strategy, ensuring that protocol deviations, eligibility criteria, safety data, efficacy assessments & other aspects of the protocol are implemented consistently across the study.
This could also include support for Case Report Form (CRF) development, and implementation of data capture tools.Perform high quality clinical data review and identify clinical data trends through patient level review and cumulative analysis, supporting Interim Analysis, Database and Post Lock activities and resolution of issues Develops specific medical / protocol training for Site Initiation Visits and Investigator Meetings, and for Debiopharm site facing roles and vendor / CRO staff.
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.
Provide input in scientific communication plan and scientific publicationsSupport new clinical scientists in their developmentRequirementsYour profileMaster'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, interpretation and clinical relevance. Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulationsHas 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 : 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 : 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 ( BenefitsDebiopharm International can offer youAn 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