• Establish near-term goals and long-range vision in implementation of current company objectives based upon principles of good clinical practice (GCP) in clinical operations and project management.
• Work closely with Chief Medical Officer and functional areas outside of clinical to influence processes and portfolio decisions while driving business process improvement initiatives.
• Accountable to ensure study teams are fully resourced with appropriately skilled outsource staff and that clinical programs are implemented and risks are managed within scope, on-time, and within budget.
• Accountable for the delivery of clinical program milestones.
• Management of risk at the program-level and provision of justification for risk mitigation and contingency plans; lead implementation of accepted plans.
• Management of third-party relationships engaged in the clinical programs.
• Ensure that the clinical project management staff is adequately trained and that issues within clinical programs are escalated effectively.
• Develop clinical project management staff to meet current and future business needs.
Program Project Management and Clinical Operations
• Ensure strong and productive interactions between study teams, functions, third-parties, and senior management in the development and conduct of clinical programs.
• Accountable for assessing and addressing issues related to the conduct of clinical programs.
• Provide input on strategy as a leader of the clinical team in development of realistic project milestones and deliverables.
• Provide expertise and direction on the activities involved with planning, conducting, and reporting of clinical data; this includes working with the team as a project management/clinical operations expert during clinical plan preparation and implementation.
• Partner with others to understand challenges, gather data on prior projects, and leverage these resources to help determine best options for current and future clinical trials.
• Work with Chief Medical Officer to develop and communicate clinical plans.
• Ensure that clinical risks, mitigation, and contingency plans are identified and communicated effectively to senior management along with alternatives and recommendations for best course of action.
• Serve as a consultant to the study teams in executing clinical operations procedures.
• Work with clinical service vendors to conduct risk assessments in ongoing clinical trials, create mitigation and contingency plans, and immediately understand the impact of any roadblocks that may affect timelines for individual studies and overall programs.
• Assess impact of project scope changes and work with vendors and clinical team members to understand the implications of the changes to implementation plans.
• Perform operations activities as required. This includes, but is not limited to monitoring report review, review and input for all protocol-related documents [e.g., protocols, monitoring plans, clinical trial registry documents, statistical analyses plans, data edit fields documents, site source documents, patient narratives, final study reports, etc.], and development and review of overall trial budgets.
• Capture trial and program metrics and timelines and provide these to Chief Medical Officer for dissemination (staff meetings, board meetings, etc.) as needed.
Submission Planning and Execution
• Drive planning of clinical submissions with vendors, functions, and Sanifit team by developing timelines, risk and contingency plans, and coordinating submission activities among all parties involved with the program.
• Provide critical evaluation of submission strategy, including planning for clinical support of regulatory agency meetings, critical path management, and issues that could prevent meeting submission objectives.
• Proactively identify and seek resolution to process gaps and risks related to submission activities.
• Assist senior medical management and clinical service vendors with the development of the clinical components of the submission dossier (e.g., clinical overview and clinical summary, narratives for patients of interest, etc.) as needed.
• Develop and maintain inspection readiness guidance and coach team members to remain inspection-ready at all times.
Vendor Management and Relationships
• Meet with and gather information on new vendors to build a knowledge base and maintain understanding of available services, thereby enhancing Sanifit’s operations and enabling the company to take advantage of new opportunities and technologies.
• Serve as primary liaison and operational leader of clinical program implementation with our clinical service vendors and consultants already under contract.
• Ensure that clinical service vendors/consultants and Sanifit adhere to contractual obligations via benchmarking trial performance against agreement terms and budgets.
• Maintain productive and cooperative partnerships with clinical vendors, demonstrating leadership and flexibility in all interactions.
• Interface with Sanifit Finance and Legal for acceptance and completion of budgets and contracts.
• Drive positive change in business processes with a view toward continuous process improvement, including development of GCP and standard operating procedures (SOPs) as well as business processes related to aspects of clinical program development.
• Ensure adherence to and documentation of SOP training for Sanifit staff members and vendors (as applicable).
• Promote and utilize project management and GCP operations tools and concepts in daily work in order to identify and bring forth areas for continual process improvement.
• Review, provide input, and aid in the implementation of new processes and procedures in nonclinical areas.
• Participate in interviewing and assessing new candidates to ensure programs are staffed to meet current and future needs.
• Contribute to the development of others by being an active source of coaching and feedback to co-workers and direct reports.
• Ensure that direct reports adhere to current policies and procedures and training requirements.
• Promote consistency in processes used that will aid in meeting company objectives.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:
- Four-year degree, preferably in a health-related or scientific field.
- At least 15 years of work experience in the pharmaceutical and/or drug development industry.
- Experience with management of clinical research organizations or drug development partnership relationships.
- Thorough understanding of and experience with the drug development process through multiple study phases (e.g., Phases I through IV).
- International clinical trial leadership.
- At least 5 years of work experience leading a team of people to deliver an objective, including hiring and performance management decision-making.
- Practical experience in initiating, maintaining, and terminating clinical trials either as a clinical research coordinator or in the role of clinical operations/development within industry.
- Practical experience performing project management for a cross-functional project.
- Excellent oral and written communication skills with the ability to communicate clearly, succinctly, and with credibility to all organizational levels.
- Strong problem-solving skills with the ability to anticipate and recognize systemic problems, diagnose the root cause of problems, and work with senior management to influence corrective actions that will prevent recurrence in other projects.
- Excellent self-management and organizational skills with the ability to independently manage workload, set priorities, and adjust those priorities as required by business needs.
- Strong interpersonal skills with the ability to create a shared vision and productively manage conflict through delivery-effective coaching and feedback.
- Understanding of business fundamentals with the ability to maintain a corporate view of programs and projects.
- Able to exercise sound judgment while taking and defending tough positions.
- Applied knowledge of project management tools and processes (e.g., management of integration, scope, timeline, cost, quality, resources, communications, risks, and procurement).
- Understanding of the requirements and company/regulatory needs concerning project documentation.
- Understanding of the practical aspects of clinical operations and elements required in the conduct of clinical trials.
- Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
- Ability to travel as needed for key meetings and KOL interactions.
- Therapeutic experience in ESRD or hemodialysis subjects, preferred.
As a federal contractor, Vifor Pharma, Inc. is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason, a genuine religious belief, on an individual basis in accordance with applicable legal requirements. All employees must be in compliance with Vifor Pharma, Inc.’s COVID-19 vaccine policy at the commencement of their employment.