Lightship is the premier provider of enterprise level, decentralized clinical research services. In this capacity, Lightship serves as a telemedicine-enabled virtual site within a clinical research study. Through the use of technology and home visits by our nurses and other medical professionals, the Lightship decentralized model makes participation in clinical research more accessible for patients. By placing patients at the center of the decentralized model, Lightship positions the patient’s home as the hub for clinical trial activities, eliminating frequent study-related visits to clinics and hospitals.
The Director Project Delivery is responsible for ensuring the delivery of projects for one or more clients, in line with contractual commitments and in compliance with GCP and Lightship/client SOPs and working practices. Their responsibilities include providing cross-functional coordination and oversight of the project team from all functional areas within Lightship (e.g. Design, Pricing and Project Finance, Clinical Operations, Patient Engagement/Recruitment, Technology and Quality) to proactively identify and solve potential risks to successful delivery, communicate with functional management to ensure adequate and timely staffing of projects, ensure team tracking of KPIs, financial management, and the creation and management of timelines to achieve study objectives.
This critical role works closely with the client lead and the project finance lead to ensure appropriate interactions and seamless handoffs between sales, operations and finance through the lifecycle of a study from opportunity through project close out. This role is responsible for ensuring that feasibility is performed/assessed for the patient recruitment funnel, the resulting enrolment plan and operational project plan, working with the relevant functional areas, and that these deliverables are completed prior to project contract signing.
Given the distributed team model at Lightship, this position operates in a remote capacity. Overtime, this position will require moderate travel – approximately 25%.
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 direct-to-patient clinical research solutions at scale
- An unmatched opportunity to grow as part of an early stage startup with industry veterans, high-caliber investors, and a massive market opportunity
- Competitive 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.
- Generous paid parental leave
- Short & long-term disability
- Life insurance and More!
This role will be responsible for:
- Provides overall project/program-level management for contracted studies within one or more clients.
- Supports strong communication and relationships between client and Lightship through tight integration, coordination and collaboration with the client lead around all communications with the client as the client lead acts as the primary point of contact with the sponsor.
- Chairs and leads internal and joint team meetings, and provides regular, accurate reporting on project metrics, status of deliverables, and identified risks/issues to leadership and, working with the client lead, to the sponsor.
- Develops appropriate early warning systems of potential/impeding barriers to the successful completion of the project, analyses information and develops innovative solutions to challenges.
- Provides effective leadership to motivate a high performance team culture and adjust mid-stream to cultivate optimal team dynamic
- Ensures Lighship team stakeholders have a clear understanding of service offerings, intersections of those offerings and protocol assessments to ensure flawless delivery
- Provides leadership on new projects/clients to define best practices and consistency across the program for study documentation, project plans, communication and escalation pathways, risk identification/mitigation/documentation/review, and roles & responsibilities
- Leads and directs cross-functional team and third parties/vendors through the development of dynamic operational strategies, and mobilization of the project team to execute accordingly while maintaining compliance with designated SOPs/guidelines, study protocol, and GCP/ICH
- Manages project costs by ensuring project resources are allocated to align with the contracted scope of work and budget to achieve planned deliverables and maintaining accurate unit forecasting and actualization relevant to work completed each month in partnership with project finance lead and other functional leads
- Proactively identifies out of scope activity to ensure the timely approval and execution of contract modifications prior to completing the relevant scope
- Ensures change orders are implemented working with the project finance lead and appropriate stakeholders to contribute to revised scope; ensures that the client lead is apprised of all changes and supports the client lead in discussions with the sponsor as requested.
- Develops cross-functional project plan that supports agreed patient recruitment funnel, enrolment plan and operational feasibility during the opportunity phase prior to contract signing, including any external vendor impacting Lightship deliverables
- Maintains cross-functional project plan including coordination and management across all Lightship functions within scope as well as any external vendor impacting Lightship deliverables resulting in effort and cost forecasts for remaining work to deliver the contracted services.
- Reviews and approves project direct and pass through expenditure per contract and/or company policy.
- Develops case studies to share across organization and for use in selling/bid defense opportunities to showcase Lightship best practices, metrics, or other achievements supporting sales as requested
- Proactively escalates risks/issues/concerns and suggested mitigation strategies to Lightship leadership for discussion, alignment and resolution pathway implementation.
- Participates in client meetings and bid defenses providing operational and strategic input in support of the Client Partner
- Identifies opportunities for continual process improvement and support in the development of best practices at Lightship
Required knowledge, skills, and abilities
- 10+ years of relevant experience
- Pharmaceutical R&D or related clinical research services industry experience required for at least 4-5 years.
- People management experience or equivalent track record in matrix teams’ management.
- 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.
Education and experience
- Undergraduate degree in scientific or business discipline
- Project Management Professional (PMP) certificate a plus
- 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.
- Excellent organizational skills and ability to manage multiple priorities
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
- Experience of leading in a global project management function where people are challenged, developed and talent management, is a plus.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Highly effective influencing and negotiations skills in challenging, ambiguous and/or changing environments.
- Highly effective verbal, written, presentation communications skills.
- 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.
- High level of energy, enthusiasm and commitment.
- Ability to build credibility quickly across a diverse range of functional teams, seniority, and geography.
- Business and financial acumen.
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 Law
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.
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