Job Details

Position Summary

We seek an enthusiastic Medical Director with a high degree of scientific acumen to help develop clinical plans for Clients Hemoglobinopathies programs and is excited by the unique opportunity to bring cutting-edge gene therapies to market. The candidate should be a team player, have basic knowledge of clinical trials and GMP guidelines, detail oriented with prior clinical research experience, either in academia or industry.

In this role, Medical Director will work across different functional teams to support the design and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility position, the candidate will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.

The successful candidate will participate in the strategic development and tactical implementation of the early clinical studies for our lead gene-editing programs. This will include providing direct medical/physician oversight for phase 1/pivotal trial and proof of concept clinical trials, and clinician input into all aspects of discovery and preclinical development, from target selection to preclinical and regulatory strategy and tactics. The ideal candidate will have an understanding of hematology and/or gene therapy, clinical development, the p

Responsibilities

• Principles of pharmacology, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans along with experience working closely with clinical operations.
• Understand (and eventually develop into local expert for the underlying scientific principles of the disease indications and pipeline gene therapies being studied
• Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy, and IND enabling studies to develop optimal translational medicine approaches to facilitate development to clinical POC
• Contribute to the development of robust product development plans for each program, including providing content for clinical development and other sections, as needed
• Identify and establish relationships with leading KOLs and principal investigators, including organizing and running KOL meetings, as needed
• Organize and present at relevant clinical advisory boards and medical/scientific meetings
• Develop protocols and oversee clinical trials as a medical monitor
• Collaborate with clinical operations and medical affairs to ensure clinical development program success
• Contribute to the development of regulatory strategy and act as the medical expert in meetings with regulatory authorities
• Ensure and support effective leadership, management and governance, and seamless collaboration across all areas of Research and Development
• Serve as the Sponsors medical representative to external collaborators
• Travel, as needed, nationally and internationally

Minimum Qualifications

• A medical degree (MD), and 3 years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or a minimum of 5 years in a related, research/academic environment
• Past experience in hematology or stem cell transplant clinical trials is preferred, but not required
• Strong scientific background with experience in reviewing & interpreting scientific and study data is required
• Medical monitor experience in clinical development, or clinical translational medicine related areas
• Track record of scientific publications strongly preferred
• Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable
• Working knowledge of applicable US and EU regulatory requirements and of the drug development process
• Experience in building and maintaining effective relationships with external KOLs, advisory boards and other key external therapeutic area influencers desirable
• Team player who works collaboratively in a challenging and fast growing team matrix environment
• Ability to work independently to resolve challenges and conflicts
• Excellent written and oral communication skills
• Integrity, honesty and highest ethical standards and a sense of personal accountability
• Quickly adapt and provide innovative solutions to challenges as they present themselves
• Ability to travel on average 20% of the time (range 0-30% each month)
• Ability to work in a team-oriented environment
• Scientifically rigorous, highly organized, and with significant attention to detail