PDC*line Pharma is a clinical-stage spin-off of the French Blood Bank (EFS) that develops a new class of potent and off-the-shelf therapeutic cancer vaccines based on a proprietary cell line of Plasmacytoid Dendritic Cells (PDC*line).
Based on a robust preclinical package and a first-in-human phase Ib in melanoma, PDC*line Pharma has initiated a clinical development in lung cancer with a new candidate (PDC*lung) and neoantigens (PDC*neo)
After a total deal value of 108M€ (123M$), PDC*line Pharma raises €20M in Series B1 financing round in December 2019. In December 2021, PDC*line Pharma raises €17,5M€ in Series B2 financing round. Find out more about the company on their website: https://www.pdc-line-pharma.com/.
In order to strengthen PDC*line Pharma’s team, we are looking for a Medical Director - Oncology (M/F).
Responsibilities :
As a Medical Director, you are responsible for providing medical and scientific input into the Study and 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.
- Provide medical advice to the PDC*line teams for study design and CDP optimization.
- Represent PDC*line with investigators, at meetings and conferences.
- Select clinical studies sites, identify investigators and thought leaders.
- Serve as the primary liaison to Clinical Science Leaders.
- Collaborate with QA, QC, R&D and RA teams to fix any medical or safety issues.
- Write study protocols; execute studies, provide medical input into data preparation, analysis, report writing, and clinical study documents (e.g. CRF, ICF and TMF).
- Provide review of overall clinical data sets, author reports and publications in interactions with Regulatory Agencies.
- Support teams in medical writing of regulatory documents such as IND submissions, briefing documents for formal meetings and present to Regulatory Agencies.
- Coordinate drug safety process in collaboration with CRO.
- Prepare, supervise and review safety documentation.
- Contribute to documents for regulatory agencies, make presentations Work with Finance Department to create and manage study budget.
- Train and develop PDC*Line Pharma staff and CRO staff on medical and safety issues.
- Participate to company presentation to investors and financial analysts.
Profile :
- Medical Degree (MD) with strong scientific background in oncology is a must.
- 5-10 years’ experience in clinical development in a pharma or biotech company.
- Excellent organizational, communication and interpersonal skills.
- Strong leadership and management skills, with solutions and results orientation.
- Working knowledge of GCP, ICH guidelines, EMA and FDA regulations.
- Ability to work in an international environment with complex problems where analysis of situations or data requires an evaluation of intangible variables.
- Good written, interpersonal, and intercultural communication skills, good team player.
- Fluent in English (writing – oral).
Offer :
- A diversified position with responsibilities within a fast-growing start-up.
- The opportunity to join a human-sized, dynamic and professional environment.
- A permanent contract or a freelance status.
- New Offices location – Legia Park since July 1st, 2023.
Your application and related information you would share will remain strictly confidential.