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Define Ventures Partners

Director, Clinical Operations & Delivery



Raleigh, NC, USA
Posted on Friday, June 23, 2023
OverviewLightship 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 expected to direct and oversee the clinical operations activities for clinical research studies conducted by Lightship. This individual will work in partnership with the Lightship Commercial team in driving business growth within designated accounts. The Director, Clinical Operations and Delivery individual oversees the development of new services, tools and strategic partnerships intended to enhance the Clinical Operations and Delivery performance and strategic selling capabilities globally, while supporting the development and execution of the functions strategic vision and priorities. This individual will manage, mentor, and develop a team of Clinical Project Managers and Coordinators, overseeing, and ensuring the delivery of assigned projects on-time, within budget and to the expected quality and client standards, 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%. The Director, Clinical Operations & Delivery is responsible for:
  • 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
  • Line managing Clinical Project Management and Study Coordination 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.
  • Independently leading assigned departmental management activities and cross functional initiatives
  • Supporting the Clinical Operations functional leader to develop the strategic vision and priorities for the function
  • Assuming the responsibilities of the functional leader in their absence if required
  • Supporting the functional leader 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
  • Contributing to the development, implementation, and maintenance of clinical processes, SOPs, and systems across Lightship
  • Supporting audits and inspections, as required
  • Other duties as requested
The Director, Clinical Operations & Delivery has:
  • Required knowledge, skills & abilities:
    • Advanced knowledge of company people management policies and procedures, including hiring, performance management, people development, strategic thinking and influencing
    • Strong global understanding of Clinical Research process in multiple countries
    • Strong leadership skills including coaching, interviewing, and providing feedback and recognition
    • Ability to establish and maintain strong professional relationships and strategic partnerships, building credibility quickly across a diverse range of functional teams, seniority, and geography
    • Sound judgement and agile decision-making – using evidence and applying judgement to balance pace, rigor, and risk
    • Excellent verbal and written communication skills
    • Detailed oriented with excellent organizational skills, in an environment with shifting priorities
    • Ability to learn and work with new technology
    • Ability to manage multiple priorities in a dynamic, fast-paced environment
    • Ability to actively support VP Clinical Operations with planning of departmental vision and evolution
    • Ability to critically review protocols, operation plans and project review materials such as metrics / KPIs and provide comprehensive analysis of components required to conduct successful research studies
    • Ability to co-develop and translate strategic objectives into operational plans and guide their execution. Has a broad, lasting impact on the organization
    • Demonstrated skill operating in situations characterized by complexity, ambiguity, and high levels of uncertainty
    • Possess negotiation skills and ability to influence with or without authority at all levels of the organization; adapting style to deliver messages or sell ideas or services
    • Comfortable advising others on complex matters
    • High level of energy, enthusiasm, and commitment
    • Track record of project delivery. Areas of experience should include Clinical Research Services, Line and Matrix Management, Project/Program Management, Portfolio Management, Performance Management, Risk Management, Financial Management, Strategy, Development and People Management / Development
  • Education and experience:
    • Bachelor's degree or international equivalent in scientific or business discipline preferred, or requisite combination of education, training
    • 10+ years' experience in relevant industry experience in Pharmaceutical R&D and related clinical research services
    • 5+ years' of people management experience or matrix teams' management
    • 4+ years' experience managing a portfolio of projects and involvement in department management activities
    • Project Management Professional (PMP) certificate preferred
    • Experience leading the delivery of multiple/complex projects/assignments in a matrix environment to demanding deadlines with minimal direction/leadership
    • Strong experience in critical path management, scenario planning, budget forecasting / management, risk identification / management, and experience with the variability of assumptions supporting robust quality clinical research services plans and the ability to deliver to plan
    • Experience in organization-wide problem solving and financial & analytical modelling and proven application of high-quality strategic analysis and ability to develop strategic/commercial recommendations
    • Experience employing highly effective decision-making strategies in resolving issues and conflicting options
    • Experience of leading in a global project management function where people are challenged, developed and talent management, is a plus
We would like to offer you:
  • An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
  • The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade virtual-first clinical research solutions at scale
  • An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity
  • Great compensation
Generous benefits package, including:
  • Top notch healthcare (medical, dental, and vision) for you and your family.
  • Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.
  • A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
  • A home office stipend to set yourself up for success in our distributed working environment
  • Company provided laptop, your choice of a PC or a Mac
  • Monthly stipend for internet and phone expenses
  • Generous paid parental leave
  • Short & long-term disability
  • Life insurance and More!
The base salary range for this role is between $164,500 and $208,00+, depending on education, skills, and experience. To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of 'believing in people' – valuing the outputs and performance of each team member.Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19. Our commitment to diversity & inclusion:Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law. EEO is the LawLightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster#jobs #careers #nowhiring #hiringnow