Offre d'emploi : Medical Director
Founded in April 2014 in Grenoble (France) as a spin-off of the French Blood Bank (Etablissement Français du Sang, EFS), PDC*line Pharma is a Belgian-French biotech company that is developing a novel class of off-the-shelf cancer immunotherapies based on a proprietary Plasmacytoid Dendritic Cell line (PDC*line) pre-loaded with peptides that are derived from target tumor antigens.
After a first-in-human feasibility clinical study in melanoma, PDC*line Pharma is focusing on lung cancer with a new candidate in phase 1b/2 clinical trial (PDC*lung) and neoantigens (PDC*Neo). The company currently comprises f 20 people and has an experienced management team. In March 2019, PDC*line signed a licensing deal with a leading Korean pharmaceutical company for the development and commercialization of PDC*lung cancer vaccine for lung cancer. The total deal value is 108M€ (123M$) plus significant tiered royalties on net sales in Asia.
In order to strengthen the management team located in Liege, we are actively looking for a:
As a Medical Director, you are responsible for providing medical and scientific input into the Study Team and into the Project Teams. You are in charge of planning, designing, developing, executing and interpreting clinical studies. Your main responsibilities are:
- Design clinical development plans, optimize and execute them efficiently and effectively.
- Drive the selection of sites for clinical studies, identify investigators and opinion leaders.
- Write or review study synopsis, protocols, reports and documents (e.g. CRF, ICF and TMF) for regulatory agencies.
- Ensure medical monitoring of clinical studies.
- Responsible in evaluating adverse events and handling safety information as appropriate, for the management of safety review boards, CROs and other vendors for study and/or safety-related issues.
- Serve as the primary medical liaison to the investigators, opinion leaders, clinical leaders and medical teams of pharma partners.
- Develop and maintain a network of medical experts in the field and represent PDC*Line in interactions with investigators, at meetings and conferences.
- Provide direction on all clinical matters to the PDC*line teams.
- Provide review and query of overall clinical data sets, clinical laboratory and author reports.
- Participate in medical writing of regulatory documents (IND, briefing documents, etc).
- Coordinate and oversee the execution of drug safety process. In collaboration with the clinical team and CRO, you are responsible for safety documentation for clinical trials.
- Participate in the development plan strategy with the other members of management and in the R&D plan development lead by the CSO.
- Medical Degree (MD) with strong scientific background and medical practice experience, a fellowship or equivalent in (immuno-)oncology is a plus.
- Experience in a pharmaceutical or biotech company, especially in early stage, exploratory clinical development of drugs and biologics.
- At least 5 years’ experience in performing early development clinical activities and safety assessment activities.
- At least 2 years of successful experience managing and directing a study or project team.
- Working knowledge of GCP, ICH guidelines, EMA and FDA regulations.
- Ability to work in a small, yet international environment with complex issues.
- Excellent organizational, communication and interpersonal skills.
- Effective time, cost and resource management skills.
- Ability to lead and motivate personnel.
- An interesting position within a high-potential clinical stage biotech company.
- The opportunity to work in a human-sized and multicultural team environment.
- A variety of interesting contacts with international exposure.
- An attractive salary package in line with the position responsibilities and your experience.
Your application and related information will remain strictly confidential.