Director, Clinical Operations
- Remote, Home Office, United States
- Employees can work remotely
- Department: Clinical Operations
Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health.
In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
The Director, Clinical Operations acts as Clinical Trial/Project Manager (CPM) and is responsible for implementing the strategy and management of assigned clinical studies or clinical programs being conducted by Aurinia Pharmaceuticals Inc. They will be a team leader within Clinical Operations and manage operational and logistical tasks to ensure efficient execution of trials within established budgets and timelines, while ensuring all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP. They will coordinate the efforts of internal and external resources to ensure efficient patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality. May serve as the functional leader for clinical research development program(s) and studies/study for an individual molecule or process initiative.
- Leads/supports the cross functional team, coordinates and oversees pre-approval and post marketing clinical trials/programs.
- Inputs/contributes to development strategy and the clinical development plan. May support scenario planning and risk benefit analyses to make recommendations to align with corporate strategies.
- Support for clinical trial preparation activities including protocol design and development, Case Report Form design, site identification, third party partnership selection (CRO, Central Labs, etc.).
- Overall accountability for vendor management and program budget.
- Responsible and Accountable for multiple global or regional programs and all clinical deliverables including:
- Primary point of sponsor contact for Investigators, Study Coordinators, and third-party vendors
- Site qualification/management and monitoring oversight
- Data management oversight activities
- Assistance with coding of adverse events
- Third party vendor (i.e., CRO) management
- Oversight of protocol compliance and protocol deviations.
- Review progress of projects and initiate appropriate actions to achieve target objectives; both budgetary and timeline.
- Provide updates and status reports on a regular basis; report on performance against plan.
- Reviews/develops budgets for clinical studies/programs and negotiates budgets and contracts with CROs.
- Manages/oversees regular review of study data.
- Assigns and oversees study related activities/tasks of Clinical Trial Associates.
- Participates in Clinical Submission activities.
- Assist with the development and implementation of SOPs for clinical trials and related activities.
- Interface with departments within and outside of Aurinia including Finance, Regulatory Affairs, Legal Affairs, New Drug Development, and Business Development.
- Provide training where necessary.
- Represent the company at Investigator Meetings.
- May direct Study Managers or line manage direct reports including developing training plans, act as mentor, and conduct performance review as required.
- May assist in planning and monitoring resource levels within studies/programs.
- May participates in due diligence activities for in-licensing opportunities.
- Participates in Clinical Submission activities.
- Other such duties as may be determined or assigned.
- Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advanced degree desirable.
- At least 10 years of experience in the pharmaceutical or medical device industry as a clinical research professional, including successful project leadership role and hands-on managerial experience running clinical trials/programs from inception to completion.
- Experience managing global clinical projects and multiple global vendors.
- Direct experience managing cross functional teams in a clinical study setting.
- Excellent knowledge of international regulatory and ICH GCP guidelines.
- Prior experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, IVR/IWRS, CTMS).
- Training and experience in monitoring of clinical trials and the related in house and investigational site activities is required. Data management experience preferred.
- Ability to work well independently as well as a member of multiple, integrated teams.
- Ability to multi-task and manage several projects in parallel while paying attention to detail. A wide degree of creativity and latitude is expected.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
- Highly effective verbal and written communication skills with internal and external stakeholders.
- Effectively collaborates with team members.
- Ability to travel (including internationally) and work across cultures.
- Demonstrated ability to motivate and mentor staff or Line management experience.
- Ability to contribute creative yet practical solutions to problems.
All candidate information will be kept confidential according to EEO guidelines