Full Time
New York City, Remote
Posted 1 month ago

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 by JR Rahn 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.

The Associate Director, Clinical Operations, has primary global accountability at the trial level within the organization. The Associate Director Clin Ops (ADCO) is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The ADCO is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol synopsis to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.

The ADCO is responsible for leading the cross-functional Trial Team (CTT) and interfaces with all trial team members, building the trial operational plan, is responsible along with the Study Clinician, for external service providers contracts and budget, in alignment with the organizational objectives. The ADCO provides global operational leadership to the execution to plan and define risk mitigation strategies and ensures implementation thereof.

The ADCO maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Clinician. This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.

Responsibilities: 

  • Leads the cross-functional Trial Team (CTT); Tracking of Project Deliverables & Timelines. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
  • Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of trial costs. Is responsible for overall contract management, including review & approval of external service provider contracts, change orders and ensures services are delivered per contract (in conjunction with Study Clinician).
  • Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within timelines. Responsible for driving the final study placement and ensuring alignment with and communication to the involved stakeholders.
  • Is accountable for oversight of all external service providers used for the trial for both in-house and outsourced studies. Is responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines. During execution, the ADCO will ensure escalated issues are appropriately resolved. For outsourced trials, the ADCO is responsible for CRO management, including initiation of the RFP and selection process, SOW development, budget and change orders (in conjunction with Study Clinician) and oversight of all deliverables outsourced to the CRO. You will be the primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
  • Ensures Trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensures that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trials utilizing the available tools.
  • Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Clinician, the ADCO ensures appropriate trial-specific training is given to Trial Team members or to the CRO. Oversee the Clinical Trial Assistant (CTA) in the set-up and coordination of Investigator Meetings, if applicable.
  • Responsible for ensuring transparent status reporting information to relevant key stakeholders.
  • Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they cannot be resolved within the function and/or Trial Team they are escalated to the PM/Program Team Meeting attendees. Manages timely and accurate documentation of issue escalation. Accountable to drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required. 

Job characteristics:  

  • Working independently within a distributed team
  • Being proactive, target driven and diligent
  • Working for multiple stakeholders and managing multiple priorities
  • Learning about the broad, rapidly evolving digital health sector

Requirements:

  • BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • Minimum of 8 years clinical trial experience in the pharmaceutical industry or CRO.
  • Willingness and ability to travel up to 15-20% of the time, defined by business needs.
  • Requires clinical research operational knowledge, project planning/management, communication, and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experience managing or leading global or regional teams in a virtual environment is required. Strong expertise in vendor management required.
  • Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. Excellent decision-making, analytical and strong financial management skills are essential to this position. Operates and executes with limited supervision. Experience mentoring/coaching others. Ability to support and participate in the hiring, training, development, and evaluation of staff on a regular basis.
  • Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

Job Features

Job Category

Clinical

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