Medical Director
BioInvent International AB / Läkarjobb / Lund
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hela Sverige Visa alla jobb hos BioInvent International AB i Lund The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it - as our
Medical Director - Clinical Development
As our Medical Director you will support the planning and execution of BioInvent's clinical studies.
The Medical Director will have a strong understanding of all phases of pharmaceutical drug development, clinical trial management, medical monitoring, and regulatory submissions. The position requires experience in collaborating with Clinical Operations, Clinical Pharmacology, Preclinical and Translational Research, CMC, QA, Regulatory Affairs, and other key stakeholders. The responsibilities include leadership and support of all functions to ensure high quality clinical development, and GCP compliance by providing medical and scientific expertise to BioInvent's clinical programs.
The main responsibilities are to:
• Lead the generation of study protocols, and production of other essential documents such as investigator's brochure, IMPD, briefing books, safety updates, responses to Health Authorities and other regulatory submissions, DSURs, clinical study reports and publications.
• Provide and support medical monitoring to the company's clinical trials.
• Closely manage and monitor pharmacovigilance activities in clinical studies, safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials.
• Support clinical development activities, including interactions and supervision of medical activities outsourced to CROs, as well as resource planning and review of study budgets.
• Ensure compliance with ICH-GCP and support the team in maintaining a clinical Quality Management System.
• Coordinate with other departments in all educational efforts, management of medical information, and reviewing and editing of medical documents.
• Participate in business development activities by supporting due diligence and partnering activities, as needed.
• Work with academic leaders/advisors to develop clinical strategy. Organize, and participate in advisory board meetings.
• Help maintain a close contact with KOLs and advisors and help enlarge the list and scope of the best consultants to BioInvent.
• Provide strategic input and support to regulatory development plans, support regulatory submissions, scientific advice meetings.
• Support corporate GO/NOGO decisions by providing recommendations based on the data generated by the clinical studies.
Essential for the role
To succeed in this opportunity, you will be an accredited medical doctor. A qualification in oncology/hematology, and/or a PhD in a biological, pharmaceutical, or physical sciences is a plus. You must have at least 6-8 years clinical development experience in the biotech or pharmaceutical industry.
Desirable for the role
• Ability to independently evaluate, interpret and present complex scientific data.
• Detailed knowledge of ICH-GCP, European, US FDA pharmaceutical regulations and guidance, drug development process.
• Strategic and critical thinking.
• Superior communication skills in cross-cultural environments
• Ability to manage complexity and uncertainty and be flexible to adapt quickly to a changing environment.
• Excellent business judgment, and problem-solving skills.
• Proven successful leadership of teams in a matrix environment.
Personal suitability is of great importance. You are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines while securing high quality deliverables. You are enthusiastic, a kind person and enjoy creating results and achieving goals both individually and together with your teams.
The company is in Lund, Sweden. However, relocation is not a requirement for European residents.
BioInvent is in a unique situation with a great potential to change the future. If this is your profile and would like to contribute to change the way cancer is treated today, you are welcome to apply for the position, we want to hear from you!
Please send us your application, personal letter and CV and tell us why you are the right person for this new position, at the latest 4th of September 2023. Interviews will be held continuously which means the positions can be filled before deadline.
Så ansöker du Sista dag att ansöka är 2023-09-04
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Bioinvent International AB (org.nr 556537-7263)
Sölvegatan 41 (
visa karta)
223 70 LUND
Arbetsplats BioInvent International AB
Jobbnummer 8021611
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