Overview:
You will drive the development of therapeutics operationally as well as strategically.
Responsibilities:
- High quality and timely execution of clinical trial strategies
• Design and creation of clinical studies, including compilation of clinical documents (i.e. protocols, investigator’s brochure, clinical study reports) or providing respective sections
• Monitor, document, interpret and ensure timely publication of clinical study data
• Ensuring projects are conducted in compliance with relevant regulatory requirements and standards
• Medical oversight of clinical trials and Investigator Initiated Trials
• Oversight of contracted medical monitoring activities
• Participation in Investigator Meetings and key scientific meetings/conferences.
• Support or conduct of early assessments of new therapeutic approaches and, as appropriate, assist in competitive intelligence and/or market assessment activities
• Maintain scientific and medical knowledge of assigned therapeutic and disease areas
• Assist in engagement and management of external stakeholders, ranging from KOLs, PIs to vendor representatives
• Management of Clinical Trial Managers.
Qualifications and Experience:
The job of Medical Director will be held by a person with;
• MD with at least 5 to 10 years of experience in clinical development of therapeutics, preferably with cell and gene therapies
• Track record of successfully initiating and progressing projects from discovery into the clinic in the hemato-oncology therapeutic space.
• Outstanding communication skills, both verbal and written in English.
• Ability to work independently and prioritize duties.
• Effective time management and organization skills and attention to detail.
• Demonstrated ability to work within small teams in a fast-paced, changing environment.