VP, Clinical Affairs

MindMed is a leading $1B+ biotech, focusing on mental health. With breakthrough clinical research in psychedelic medicine and treatments, utilizing novel AI digital measures, we are turning our vision to help millions of people around the world into reality. 

Founded in 2019 and with a current team of 50, we are continuously expanding our presence throughout North America, central Europe and Australia and are constantly searching for high impact individuals in various clinical, technological and business operations domains to strengthen our team.

We are seeking a motivated candidate who is passionate about supporting the growth of an innovative company committed to novel therapeutic approaches to psychiatric conditions and improving clinical development through better measurement. We help patients unlock the healing power of the mind through psychedelic inspired medicines.

As a Senior Director Clinical Science you will lead the study design and oversee the planning and execution of clinical trials aligned with the clinical development plan focused on neuroscience, psychiatry and addiction medicine.

Responsibilities:

• Provides clinical science leadership within assigned teams.
• Leads the study design of clinical trials on assigned programs, is responsible for the preparation of clinical study synopses and serves as a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports.
• Responsible for providing or supervising medical monitoring activities for all human clinical trials including support of adverse event reporting and safety management.
• Responsible for ongoing benefit/risk and data integrity assessment, monitoring adherence to protocols and helping in the investigation of protocol deviations.
• Provides clinical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents.
• Develops relationships with investigators and external organizations and experts to conduct advisory committees, advocacy review and optimize study design and executions.
  
  

Requirements:

• Scientific degree, masters level or PhD and 5+ years broad bio/pharmaceutical industry experience in drug development or equivalent. 
• Additional training and/or experience in psychiatry, neurology or addiction medicine, desirable.
• Proven relevant experience in conducting trials ensuring safety and data integrity.
• Background and proven relevant experience in engaging with clinical operations and trial management.
• Understanding of the drug development process including technical, business, and regulatory issues.
• IND/NDA experience is desirable.
• Ability to develop knowledge about international regulatory requirements and processes to support socialization with regulatory authorities.
• Diplomacy and professionalism, ability to build positive relationships both with company leadership and external experts. 
• Able to command respect from peers and subordinates, capable of highly-independent work as well as being a team player and role model.
• Excellent interpersonal, verbal and written communication skills.
• Proven ability to work remotely and with remote internal and external interdisciplinary teams
• Problem-solving and strategic planning skills .
• Excited by innovative ideas in the clinical research space.
• Self-motivated, resourceful with a ‘get  the job done’ attitude in a fast-paced team environment.