Director, Clinical Operations & Delivery

at  Lightship

OVERVIEW

Lightship is the virtual-first provider that is perfecting the way clinical trials get executed. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence in clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house patient care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.
The Director, Clinical Operations and Delivery is an experienced leader to direct and oversee clinical operations activities for the clinical research studies conducted by Lightship and support business growth. This individual manages the development of new services, tools and strategic partnerships aimed at enhancing the ability of the Clinical Operations and Delivery performance and strategic selling capabilities globally.
This includes managing, mentoring and developing a team of Clinical Project Managers, overseeing, and ensuring the delivery of assigned projects on-time, within budget and to expected quality and client standards, and being the key point of escalation for clients and internal stakeholders to ensure risks are mitigated and issues are managed effectively.
Given Lightship’s distributed model and the remote nature of this position a successful candidate will possess a willingness and desire to work independently without significant oversight. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate US West Coast, US East Coast, and UK-based time zones, based on business need. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual’s daily life.
Additionally, this position will require moderate travel, approximately 20%.

• Setting direction, strategy, and performance standards for the assigned project teams
• Providing oversight of all project activities and responsibilities (including, but not limited managing protocol and consent form development; vendor selection and management; developing and managing study, project, and departmental budgets; establishing timelines and milestones; invoice review and project financial management, review, and execution of contracts; overseeing study set-up, conduct, and close out; and completing appropriate reporting as needed) to ensure:
• Project tasks are delivered to high quality standards on-time and within the budget
• Services provided to clients are compliant with Lightship policies, procedures, SOPs, ICH GCP, client contractual expectations (including the approved protocol) and country-specific regulatory requirements
• Managing Clinical Project Management staff to optimize employee performance levels, ensure retention of high performing Lightship team members and cultivate optimal team dynamics
• Coaching and mentoring other management team members
• Ensuring appropriate employee resources are available to meet corporate / client/ project objectives while achieving optimal utilization of staff
• Accurately projects resource needs to ensure timely hiring of staff
• Adjusts resource allocation for project work as appropriate to ensure corporate targets are maintained while assuring client/ project objectives are achieved
• Leading Lightship’s continuous process improvement initiatives, including identifying and executing opportunities to optimize departmental performance and best practices at Lightship
• Ensuring project quality metrics align with company, client, and clinical operations objectives
• Providing input to proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
• Provides guidance/ insight on aspects of Clinical Operations and Delivery, as well as contingency planning, to accommodate project or therapeutic-specific nuances while identifying potential impacts of the same to budget
• Participates in client presentations and / or bid defense meetings, as required
• Contributing to the revision of scope and ensuring change orders are implemented, and that Client Partner is apprised of all changes and supports discussions with sponsor
• Reviewing and approving project direct and pass-through expenditure per contract and/or company policy
• Proactively identifying potential project risks, barriers and issues and works to mitigate their impact through direct action or providing guidance to others
• Ensuring consistent delivery across portfolio with assigned client(s)
• Working collaboratively with Client Partner to support portfolio growth
• Acting as the key point of escalation for risks / issues related to the assigned project team’s deliverables and leads regular meetings with Clinical Project Management team and cross-functional directors as needed to review and discuss project risks, status, and opportunities for awarded projects to improve delivery, profitability, quality and/or client satisfaction. Leads project governance activities for assigned clients
• Managing the development of new services, tools and strategic partnerships to enhance Clinical Operations and Delivery’s performance and strategic selling capabilities globally and within assigned region
• Contributing to the evaluation of studies for operational feasibility in the virtual first model
• Establishing and maintaining effective communication and collaboration with Lightship personnel from various functional areas, including quality, regulatory affairs, technology, legal, design, recruitment, finance, etc.
• Supporting VP in identifying hiring requirements based on departmental needs, and actively participating in candidate review, selection, and successful on-boarding
• Regularly reporting on data related to studies and other departmental initiatives to VP Clinical Operations and Executive Leadership Team (as necessary)
• Participating in the evaluation of study personnel, including developing performance goals and objectives, and providing training and support as needed
• Independently leading assigned departmental management actives and cross functional initiatives
• Supporting audits and inspections as required
• Independently leading assigned departmental management activities and cross functional initiatives
• Supporting other departments or cross-functional needs as the business requires
• Other duties as requested