Medical Director Phase III, Oncology

Lausanne, Vaud, Switzerland · Clinical Development

Description

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 Headquarters in Lausanne, we are looking for


MEDICAL DIRECTOR Phase III, ONCOLOGY

(Contractor or temporary assignment – 12 months)

The Medical Director will lead the clinical development Phase III program of an innovative first in class NCE in Head & Neck cancer. He/she will work in close collaboration with the Global Project Leader, the Global Medical Director, the project core team and the cross-functional clinical study team to design and execute the clinical program.

Your responsibilities

Develop the Phase III clinical strategy and design the Phase III protocol for the product, taking into account current medical practice, regulatory requirements, business needs as well as the competitive environment;

Be an integral member of the development team and work closely with Clinical Operations, Biostats, Drug Safety, Regulatory Affairs and Business functions.

Provide functional leadership to the Clinical Scientist assigned to the program with respect to monitoring, reviewing and interpreting patient profiles, safety and efficacy data of the Phase III study on an ongoing basis and assure the completeness and quality of the data.

Responsible for the updating of the Clinical Development Plan with respect to Phase III activities.

Consult with internal and external experts for the generation of an innovative and optimal designed Phase III program and Clinical Trial Protocol.

Deliver and execute the Phase III clinical development plan in collaboration with study teams by ensuring: efficient execution/compliance of protocols, appropriate study medical monitoring, timely resolution of issues, and reporting of study results including communication at congresses.

Work coordinately with PV team to provide efficient and proper medical review of safety of participating subjects in the phase III study including SUSAR, AESIs, SAEs review.

Coordinately work with the project team and study team to deliver phase III data update for DSUR, IB IND updates and other regulatory and/or business required documents.

Provide guidance and support to the clinical study team with respect to feasibility studies for identifying lead investigator(s) and high quality investigational sites and the organization of Investigator Meetings.

Act as medical expert for clinical study teams, CRO's, study sites and others.

Develop and consolidate a network of Key Opinion Leaders /investigators, participate in medical congresses and symposia and take the lead in the organization of Scientific Advisory Boards.

Develop the scientific communication plan and supervise the development and delivery of scientific publications and scientific presentations to internal and external stakeholders.

Provide medical expertise for interactions with Regulatory Authorities worldwide.

Provide leadership to ensure the successful delivery of the clinical program, proactive identification and mitigation of risks, elaboration of contingency scenarios, swift handling and resolution of issues and uncertainties, execution of the program to the highest scientific and GCP quality standards.

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