Job description
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.
Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
The Director of Clinical Operations has primary accountability of all trials in either Early or Late Phase within the organization. The Director is accountable and provides operational expertise and guidance to the junior members of Clinical Operations to ensure the successful cross-functional delivery all of global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The Director of Clinical Operations is accountable for global trial-level oversight of all external service providers; responsible for oversight of all Clinical Operations assigned trial leads for 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 Director of Clinical Operations may represent the Operations department at Program Team meetings and interfaces with all Clinical Operations assigned trial leads to provide oversight and guidance in building all trial operational plans, managing program budgets with oversight of trial level budgets and contracts, in alignment with the organizational objectives. The Director provides trial-level operational leadership to assigned Clinical Operations trial leads to the execution to plan and execution to plan and defines trial level risk mitigation strategies and ensures implementation thereof. The Director of Clinical Operations is responsible for timely escalation of all risks identified to the Senior Director of Clinical Operations.
The Director will provide oversight of all trial budgets, and report back to the Senior Director of Clinical Operations any issues/risks identified.
Responsibilities:
- Responsible for all trial level operational oversight and leadership of the Clinical Operations assigned trial leads
- Responsible for implementing the tracking of project deliverables & timelines at the trial level, including timely escalation of risk to trial deliverables and milestones to the Senior Director of Clinical Operations
- Ensures escalation of identified risks to the Senior Director and deploys timely mitigation strategies at the trial level
- Provides guidance and oversight of all trial budgets, ensuring accurate trial budget management by the assigned Clinical Operations trial leads; responsible for reporting all trial budget updates, inclusive of risks, to the Senior Director
- Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within timelines. Accountable to drive the final study placement and ensure alignment with and communication to the involved stakeholders
- Is accountable for trial-level oversight of all external service providers used for all clinical trials for both in-house and outsourced studies; and responsible for timely escalation of issues to the Senior Director
- Accountable that the trial(s) is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
- Accountable for the management of Health Authority inspections and internal QA audits
- Responsible to ensure transparent status reporting information to relevant key stake holders and the Senior Director
- 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
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
- Experience leading Global Early and/or Late Phase trials, ideally in the psychiatric space
- 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
The starting base pay range for this position is $182,805.00 - $220,941.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks!
