Manager, Digital Medicine - Clinical Operations

MindMed is a clinical-stage biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental health. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

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.

Responsibilities

• Day-to-day oversight and independent management of all  operational aspects of the clinical trials across multiple digital programs
• Development and management of clinical study budgets and timelines
• Review of clinical study documents including clinical study protocols, statistical analysis plans, clinical study reports for future MindMed studies
• Selection, enrollment, and management of study sites - facilitating all start-up activities such as investigator recruitment, site contracting, IRB/IEC committee submissions
• Development of presentations, handouts and other materials used within the clinical studies as well as in externally facing activities (business development, marketing, product development, etc.)
• Plan and manage regulatory conversations and submissions 
• Work closely with all other departments of MindMed to understand the full product portfolio and business development requirements. 
• Participate in externally facing activities with industry and research partners, such as project proposals, project management or customer success processes
• Be an active member of Digital Medicine operations supporting our growing organization    
• Have a business first approach with strong attention to detail
• Drive cross organizational change with your excellent communication, cross team interaction and project management skill sets
• Own communications and team leadership with outside partners
• Proficiency with productivity tools and GXP for clinical development and smooth integration into complex, high growth organizations. 

Requirements  

• 5+ years experience working in clinical operations 
• Background and proven relevant experience in GCP, clinical operations, and trial management
• Experience working with technology in clinical trials (e.g. doing UAT on an EDC, incorporating an eDiary or ePRO in a trial, training site staff in a medical device, etc.)
• Experience with site management and cultivation of strong relationships with KOLs, Investigators, and study sites
• Advanced skills related to communication, compliance and (clinical trial) project management
• Ability to effectively interface with medical personnel at clinical site(s)
• Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, IRB/IEC submissions, and other trial-related documents
• Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas and technologies used at MindMed
• Previous experience with clinical studies in mobile health, medical devices or medical software is an advantage.
• Understanding of  international regulatory requirements and processes to drive socialization with regulatory authorities
• Excellent interpersonal, verbal and written communication skills
• Problem-solving and strategic planning skills 
• Excited to develop and execute  innovative ideas in clinical research space
• Experience with developing and executing successful patient recruitment strategies is a plus
• Self-motivated, resourceful with getting the job done attitude in a fast-paced team environment
• Based in US or Canada