Associate Director, Clinical Operations - Late Phase

The Associate Director, Clinical Operations, has accountability at the trial level within the organization. The Associate Director Clin Ops (ADCO) is accountable for, and provides, operational expertise for the successful cross-functional delivery of an assigned global clinical trial, within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The ADCO is accountable for the trial level 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 and Clinical Scientist, for external service providers contracts and budget, in alignment with the organizational objectives. The ADCO provides trial operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof. 

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 the delivery of the trial within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of trial costs. Is responsible for trial-level contract management, including review & approval of external service provider contracts, change orders and ensures services are delivered per contract
• Provides trial level leadership to drive the implementation of feasibility and site selection according to timelines in alignment with and communication to Clinical Operations Leadership (Senior Director/Executive Director)
• Provides oversight of all external service providers used for the trial for both in-house and outsourced studies; responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines.
• Work collaboratively with the cross-functional team to ensure the trial is operationalized in compliance with global health authority regulations and guidelines 

• Partner with Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure EAP and Phase 4 activities are fully integrated into the overall asset strategy and Target Product Profile (TPP)
• Provide Clinical Operations leadership to ensure EAPs are compliant, scalable, ethically sound and aligned with regulatory guidance
• Work closely with the Executive Director, Expanded Access and Phase 4 Clinical Strategy to ensure the execution of Phase 4 trials address regulatory commitments, payer needs and scientific gaps
• Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trial 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 and Clinical Scientist, the ADCO ensures appropriate trial-specific training is given to Trial Team members and/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 CTT and if they cannot be resolved within the function and/or CTT they are escalated to the Senior Director/Executive Director of Clinical Operations in a timely manner
• Manages timely and accurate documentation of issue escalation and provides trial-level insight to drive lessons learned and process improvement initiatives during and after trial milestone completion

REQUIREMENTS: 

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy), 
• Minimum of 6 years’ experience leading Late Phase clinical trials within the pharmaceutical industry or CRO with at least 3 years’ experience managing Phase 4 and/or Expanded Access Program trials, preferably 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
• 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 $168,856.00 - $192,641.00. 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 vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave and some fun fringe perks!