Director, Clinical Operations – fhi360 – Durham, NC, USA
The position requires an operations expert primarily with experience in low-resource settings and with vaccine trials to oversee a portfolio of clinical trials including, Ebola clinical trials in West Africa. GCP, clinical trials, and developing country experience essential.
Job Summary / Responsibilities:
The Director, Clinical Research is responsible for setting the overall direction, strategy and performance standards for Clinical Research activities (including the planning, execution, monitoring, and reporting of international clinical trials) within GRS. The Director, Clinical Research mentors and leads the Clinical team, maintaining the appropriate resources to meet contractual obligations while ensuring adherence to quality management practices. The Director, Clinical Research, provides strategic direction ensuring that the organization and conduct of regulatory and non-regulatory clinical programs is in compliance with policies and procedures, Regulatory Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives. The Director, Clinical Research sets the overall direction and strategic implementation of trial execution for investigational drugs and devices to document safety and efficacy, and ensure data integrity (in collaboration with other function groups, e.g., data management and biostatistics). The Director, Clinical Research, provides oversight of trials to ensure high quality products are delivered on time and within scope and budget.
-Determines the overall direction, strategy and performance standards for clinical research projects conducted within GRS.
-Oversees activities related to Clinical Research infrastructure in GRS (e.g., SOPs, WIs, Clinical Trial Management System, budget and planning).
-Provides Clinical Operations expertise and leadership to cross functional project teams for assigned products and indications.
-Ensures that services provided to clients are compliant with FHI 360 SOPs and GRS procedures, ICH-GCP and country-specific regulations as well as client contractual expectations.
-Develops and maintains strong business relationships with clients and key opinion leaders.
-Proactively projects resource needs to ensure timely hiring of Clinical Research staff.
-Ensures appropriate staffing resources are available to meet client project objectives.
-Oversees and coordinates the timely development of all essential project documents including project plans, protocols, informed consent forms, case report forms, and monitoring tools.
-Oversees selection and management of external service providers to ensure project objectives are met within required timelines and budget through vendor contracting process.
-Develops collaborative alliances and relationships with external service providers, investigators, key opinion leaders and advisors.
-Oversees/participates in the implementation of sponsor and investigator meetings, conferences and workshops.
-Contributes to scientific publications and presentations for journals and symposium.
-Participates in client presentations and bid defense meetings.
-Provides input to proposals for project bids to ensure that projects can be implemented and executed within contractually agreed upon timelines and budgets.
-Engages in strategic planning activities and implements strategic decisions into operational plans for GRS.
-Provides strategic input into the planning and selecting sites and subject recruitment strategies. Provides oversight of programs and trials to ensure high quality products are delivered on time and within scope and budget.
-Evaluates and reviews project tasks with Clinical team and implements required changes for all trials (re-scoping, postponement, revised plans to mitigate risk).
-Develops and implement new and improved processes related to trial planning, budgeting, control and management.
-Manages senior level staff (e.g. Associate Directors) both in line management and technical management capacities.
-Leads study team responsible for implementation and execution of clinical trials.
-Mentors and develops staff to increase employee performance levels and assures retention of high performing staff.
-Propose and help to develop systems:
- To operationalize the study protocol ensuring that the data collected are reliable, verifiable and generated in a timely manner
- To ensure enrollment and conduct of the study is in compliance with GCP and applicable ethical requirements
- To generate and maintain source documents that support study data
- To establish and maintain cold chain for study vaccine
- To establish systems for expedited reporting of adverse events
-Provides guidance on how to effectively recruit and retain study subjects (perhaps considering outreach models for more remote locations)
-Helping to establish project management systems to monitor performance, deliverables and study metrics
-Helping to establish cross cutting implementation and reporting systems across study sites and partners to ensure consistency of study conduct
Applied Knowledge & Skills:
-Proven ability to lead an international cross functional clinical research team. Exhibits an open and constructive leadership style.
-Deep knowledge of clinical trial management techniques and tools.
-Extensive knowledge of global clinical trials management environment.
-Knowledgeable about tools used to track trial deliverables.
-Proven experience in trial management, risk mitigation and change management.
-Able to work closely with clinical research Finance Management to understand customer’s needs, study budgets and forecasting.
-Extensive knowledge of international clinical research regulatory guidance documents and regulations.
-Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
-Good computer skills including knowledge and experience of Microsoft Office applications.
-High degree of accuracy and attention to detail.
-Well-developed oral and written communication skills.
-10 years of experience in drug development (regulatory affairs, clinical development, clinical project management, clinical operations).
-At least 8 years’ experience in drug development gained in a CRO, Pharmaceutical or Biotechnology company.
-Extensive international experience with a broad range of clinical trials (Phase I-IV) and epidemiology clinical research studies.
-Documented experience of operating in a resource constrained work environment.
-Excellent knowledge of the drug development process from pre-CTA/IND status through to post approval marketing studies.
-Excellent understanding of clinical research regulations and guidance in US, Europe and other international territories.
-Experience in third party service provider selection, contracting and management.
-Experience in managing budgets, financial forecasting and cost accrual processes.
-Experience with Clinical Operations line management.
-Demonstrated project and operational management and leadership skills (e.g. managing cross functional international teams).
-Experience in managing relationships with pharmaceutical/CRO clients and other external collaborators.
Problem Solving & Impact:
-Demonstrates good judgment, strong analytical thinking and problem solving and can differentiate between critical and non-critical issues to manage appropriately.
-Demonstrates excellent time management, critical thinking, and decision-making.
-Demonstrates a results-orientated, accountable, flexible approach to problem solving. Demonstrates excellent planning and organizational abilities.
-Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
-Decisions may affect a work unit or area within a department.
-Ability to read, interpret and develop clinical protocols and all associated materials.
-Ability to write clinical reports, protocols, business correspondence, and procedural manuals.
-Excellent communication skills, including effectively presenting information and responding to questions from project teams, external vendors and clients.
-Prior experience and demonstrated success in working with PIs and research coordinator teams required.
– Ability to establish and maintain systems and processes necessary to control and report trial status and activities.
-Ability to ensure that quality, regulatory-compliant clinical projects is conducted on time and within budget.
Supervision Given / Received:
-Leads an international team of approximately 35 project management and clinical operations staff including regionally-based Associate Directors, Clinical Operations.
-Reports to a Director.
Technology to be Used: Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.
-10% – 25%
Typical Physical Demands:
-Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Master’s Degree or its International Equivalent – Biology, Chemistry, Clinical Trials, Life Science, Sciences or Related Field.
Management Experience – 5+ Years
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360’s Career Center at http://www.fhi360.org/careers or through the Employment section at www.fhi360.org. Please submit CV/resume and cover letter including salary requirements. Please specify source in your application.
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, disability or status as a veteran with respect to policies, programs, or activities.