Associate Medical Director Oncology

Vor 3 Tagen

Lausanne, Schweiz Debiopharm Vollzeit

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve 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. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first 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.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

For our Clinical Development organization based at our Headquarters in Lausanne, we are looking for an

Associate Medical Director Oncology

You will contribute to the global clinical program of one or more compounds by supporting the Medical Director responsible for that compound. With supervision, you will oversee the direction, planning, execution and interpretation of Phase I/II clinical studies or research activities of a clinical development program. You will participate in cross-functional team(s) to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.

An Associate Medical Director is expected to perform their responsibilities under supervision of an executive MD. The role of an Associate Medical Director offers the opportunity for accelerated career growth to a Medical Director who is the clinical leader responsible for the clinical development of the program of a compound.

**Your responsibilities will be but not limited to**:
Be an integral member of the clinical development team and the clinical study team and drive execution of the clinical study in partnership with other functions
With appropriate supervision, manage the design and implementation of study protocols for a clinical development program in support of the overall Clinical Development Plan
Work closely with Pharmacovigilance, Clinical Operations, Regulatory Affairs, Biostatisticians and Business functions to ensure appropriate site selection, efficient execution of study protocols and overall timelines for key deliverables
Be responsible for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating study data pertaining to safety and efficacy of the compound internally, and where appropriate to forums externally
Contribute to analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents
Provide insights to the development and study team with regards to current medical practice and identify unmet need
May contribute to the generation of the Clinical Development Plan and Target Product Profile as the clinical representative for the protocols for which the incumbent has responsibility, when applicable
Participate in Key opinion leader interactions related to clinical study and its disease area(s)
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May contribute to regulatory responses and discussions
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research
**Requirements**:
Medical Doctor with adequate clinical experience in oncology; This may include Oncology drug development experience from academia, looking to move into their first to industry role, or pharmaceutical drug development of at least 2 years;
Clinical or pharmaceutical experience in oncology (solid tumors) is desirable
Evidence of keeping up to date with the recent development in clinical practice and scientific progress;
Open-mindedness, flexible and willing to learn with a high level of scientific / medical curiosity and strategic mindset;
Being able to deal with uncertainty, manage risks and drive a proper decision making;
Excellent written and verbal communication skills
Leadership and ability to collaborate in a team within an matrix organization, while remaining autonomous and having an Innovative mind-set
Knowledge of GCP, clinical trial design, statistical analysis methodology, and of ensuring compliance with GCP, SOPs, and regulatory requirements.

**Benefits**:
International, highly dynamic environment with a long term vision.
Cross-functional collaboratio

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