Start of mission
December 19, 2019
Type of contract
DescriptionOverall Objectives and Purpose of the role
This role is within the clinical affairs team reporting to a senior medical director of clinical development. You will be a core team member within a matrix organization of a fast growing biotech company in the immune-oncology space.
It is a perfect opportunity for a young oncologist, who is passionate about clinical development, and have hands-on experience in drug development, either in industry, academia or in a CRO.
You will be acting as a study level physician, involved in the design, conduct, monitoring, data interpretation and reporting of phase I/II clinical trials of one or more immuno-oncology agents, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (GCP) and regulatory requirements.
Main responsibilities and key tasks
Develop clinical Trial protocol
- Develop a well thought, and medically solid clinical trial synopsis aligned with the clinical development strategy.
- Support clinical operations team to the selection of investigators/sites to run clinical trials.
- Support regulatory team for successful submission of protocol to regulatory authorities.
- Serve as a trial level physician and medical monitor for clinical studies.
- Managing and oversee the medical monitoring teams of CROs.
- Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators.
- Work in close collaboration with the pharmacovigilance team to ensure adequate overview of the safety signals in the ongoing trials.
- Work in close collaboration with the data management and statistics team to ensure proper analysis of clinical trial results.
- Maintain up to date awareness of all important advances within a given disease area through scientific literature, attendance at critical meetings and relationships with Key Opinion Leaders (KOLs).
- Establish and maintain communications with prominent clinical investigators in field of expertise. Liaise with internal and external medical community to follow developments within area of expertise.
- Writing of medical section in investigator brochure and other regulatory documents.
- Contributing to writing clinical study report
- Contributing to publications, data presentation at scientific meetings, and manuscript writing.
ProfileExperience and Qualifications
- Graduate of a recognized school of medicine with an M.D. degree or equivalent.
- Board Certification or Eligibility in Oncology is required.
Specialty training and/or clinical experience and strong academic track record in Immuno-Oncology, Tumor Immunology, or Immunotherapy.
- Experience in medical monitoring of phase I/II clinical studies in industry, CRO or academic setting.
- Experience in protocol writing and preparation of submission to regulatory authorities.
- Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications).
- Experience in communication with FDA/EMA (e.g. cooperation on an industry sponsored phase 3 trial).
- Participated as principle investigator or co-investigator in academically. sponsored or industry sponsored trials
- Previous participation or coordination of advisory boards.
Additional Skills/ Behaviors
- Highly motivated, dynamic physicians with aspiration to evolve and develop in the clinical development space.
- Perfect command of spoken and written English.
- Training in statistics or clinical trial methodology.
- Good knowledge of French written and spoken.