Project Director/Senior Project Director

Highline Sciences is a specialized, full-service CRO and consultancy founded from within an oncology biotech to provide a better solution for innovative biotech companies. We are purposefully a different type of CRO. We aim to recruit, develop, and retain industry super stars that are curious, passionate, and want to make a difference. We’re looking for people who share our vision and want to contribute their unique skills and experience to a shared mission.

Job Summary:

Responsible for the planning and implementation of clinical operations deliverables, primarily site management and clinical monitoring of assigned project(s). Manage and contribute to continuous process and quality improvement within the Clinical Operations department.

Independently serves as Clinical Trial Lead and/or Strategic Oversight (as assigned) on complex studies, applying and providing guidance to clients and team members on best practices tailored to the applicable project, patient population, investigational product and client. Responsible for coaching/mentoring and supporting the CRA team and representing the clinical operations function to the client.

Serves in a line management and leadership role with minimal supervision and guidance.

Job Responsibilities:

Lead/Perform independently, with minimal guidance and oversight:

• Manage clinical operations deliverables including timeline, quality, scope, and financials
• Develop plans, monitor resource allocation and ensure that clinical site management and monitoring is being delivered with quality and efficiency
• Proactively identify risks and escalate to Project Manager and other appropriate functional leads
• Together with the Project Manager, ensure transparent communication both internally and externally regarding study progress and issues
• Develop and maintain project-specific clinical operations plans as required per project (e.g. Clinical Monitoring Plan, Cohort Management Plan, Recruitment Plan, etc.)
• Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs
• Develop training materials and conduct training for the clinical operations team throughout the project lifecycle
• Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency and quality
• Manage CRA resourcing, site assignments, visit schedules and serve as the initial point of contact for clinical operations and monitoring issues
• Review and approve site monitoring visit reports; monitor and track related metrics for compliance with Clinical Monitoring Plan and Highline SOPs
• Conduct monitoring visits, co-monitoring visits, assessment visits and/or team training as necessary
• Provide strategic oversight for (a portfolio of) projects as assigned
• Line manage Clinical Operations personnel (including interviewing and selection, terminations, professional development and performance appraisals)
• Contribute to management of department level metrics, quality and risks
• Contribute to development and review of department level Standard Operating Procedures, Work Instructions and other guidance documents
• Identify and manage implementation of department level initiatives, growth and training needs
• Contribute to business development activities, including but not limited to: meeting prospective clients, proposal and budget development, bid defense meeting preparation and presentation

Minimum Qualifications:

• Minimum of thirteen (13) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
• Minimum of ten (10) years Clinical Trial Lead/Manager or Clinical Project Manager or relevant clinical operations experience at a CRO, biotech or pharma company
• Or equivalent demonstrated skill set

Plus:

• In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the critical elements of success
• Early phase clinical trial experience in oncology
• Prior experience working on Global clinical trials in a Clinical Operations role
• Effective at integrating global clinical operations teams and leading them through challenging and complex situations
• Experience overseeing a program or portfolio of projects
• Excellent communication, planning, decision-making, risk management, negotiation, conflict management and time management skills
• Experience in the full study life-cycle
• Experience presenting and negotiating with senior internal and client leadership

Preferred Qualifications:

• Prior experience in a Clinical Research Associate related role at a CRO, biotech or pharma company
• Direct line management experience
• Leadership position experience
• Working understanding of the drug development life-cycle within oncology products

Our core belief is that it’s all about the team.

More specifically, bringing great people together to deliver incredible outcomes. With this approach, we are a more flexible, collaborative, innovative, inspiring and successful organization. We also happen to have a lot of fun.

We believe in questioning the norm and looking for alternatives. We seek out team members who are driven by curiosity and understand the power of the collective. We encourage continual learning and constructive feedback. We strive to build and maintain trust, both internally and externally.