Executive Medical Director, Oncology

vor 1 Tag

Lausanne, Schweiz Debiopharm Vollzeit

Description

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 Research & Development organization based at our Headquarters in Lausanne, we are looking for a

Executive Medical Director, Oncology

You will be the clinical leader responsible for the global clinical program of one or more compounds. You will develop and lead the clinical strategy and development of the compound(s) and the related clinical trial(s) end-to-end to achieve overall business objectives.

An executive Medical Director is expected to perform his/her responsibilities independently, including participating in strategic health authority (HA) interactions and due diligence processes. In this role you may be responsible for the management and supervision of Medical Director(s) within the project or of other project(s).

**Your responsibilities will be but not limited to**:
Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology - hematology) taking into account current medical practice and unmet needs; advances in both biological sciences and data sources; as well as competitive environment
Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned program(s) to ensure: successful delivery of the development plan, anticipation and dealing with uncertainties; generation of scenarios and relevant information for decision making; and managing risks.

Clinical deliverables may include but are not limited to clinical study synopsis and protocol(s), Investigator Brochure, program specific standards, clinical components of regulatory documents/registration dossiers, publications, and in-/out licensing activities

Deliver and execute the clinical development plan(s) in collaboration with study teams by ensuring: efficient execution of protocols, appropriate study medical monitoring, timely resolution of issues and reporting of study results including communication at congresses
Be an integral member of the clinical development team and drive execution of the clinical program(s) in partnership with other functions (e.g. Clinical Scientist(s), Project Management, Clinical Operations, Biostats, Regulatory Affairs and Business functions) to support decision milestones, regulatory requirements, market access and potential out licensing
Responsible for the generation of the Clinical Development Plan (CDP) and is a major contributor to the Target Product Profile (TPP) and Integrated Project Plan (IPP). Present CDP and other study project-related topics to Leadership Team for validation
Consult with internal and external experts for the generation of an innovative and optimal Clinical Development Plan including design and timing of individual study protocols
Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., study teams, Translational Medicine, Regulatory Affairs), and internal decision boards
Provide Clinical Development input in due diligences both for the in-licensing and out-licensing of compounds
Management and supervision of Medical Director(s) within the project or of other project(s)
**Requirements**:
Medical Doctor with adequate clinical experience in oncology;
Expertise in solid tumors is a must and expertise in hemato-oncology or radio-oncology is a strong plus;
7-10 years of successful and solid experience in oncology early and late drug development, from First In Human to Phase III study in the pharmaceutical industry, including in best practice big pharma;
Evidence of keeping up to date with the recent development in clinical practice and scientific progress
Track record of having led at least one oncology development program through different stages
Proven track record delivery and publication of clinical trials in oncology an/or hematology. Open-mindedness, flexible, with a high level of scientific / medical curiosity and strategy mindset;
Being able to deal with uncertainty, manage risks and

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