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 a
SENIOR CLINICAL SCIENTIST ONCOLOGY
The 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.
Your responsibilities include, but are not limited to:
- Contribute to the development of clinical development plans (CDPs) and protocols for Oncology clinical studies from PhI to PhIII in close collaboration with the MD Oncology;
- 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.
- Represent Clinical Development 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. Provide input in scientific communication plan and scientific publications
- Support new clinical scientists in their development