Manager, Clinical Operations

Description

Our Mission: Changing the trajectory of autoimmune diseases.

Our Vision: Enabling patients to live their fullest life.

We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care.

Along with driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies.

We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own Quality, and we proactively integrate Quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and “We Care” so that patients can take our drugs with confidence.

Our Strategy Leverages The Skills And Knowledge Of Our Expert Team And Our Deep Experience In Principled Drug Development And Commercialization. Aurinia’s Working Environment Enables Every Individual To Thrive In a Professional Atmosphere Guided By Our Culture Values:

• Achieve together
• Collaborate
• Explore & build
• Act responsibly
  
  

Together, we drive to change the trajectory of autoimmune disease for patients in need.

Overview

Accountable for the planning, execution, timelines, budgets, resources and overall direction of one or more clinical programs in accordance with organizational SOPs, policies and GCP/ICH guidelines.

Responsibilities:

• Assumes leadership role for specific programs, serving as the central clinical operations contact for one or more clinical projects. Accountable for Clinical Operations activities and cross functional project management at the program team level.
• Responsible for managing all study related timelines and budgets.
• Active participation in protocol design and preparation to insure consistency within a program or across more than one program.
• Oversee and provide cross functional leadership for clinical operations staff during all stages of the study.
• Study start up including investigator recruitment, site feasibility, vendor selection, CRO, Central Laboratory, CRF development, edit specifications, procurement of clinical trial insurance, collection of regulatory documents, IRB/EC submissions and organization, study team training, content and planning of investigator meetings.
• Execution period (managing enrollment timelines, vendor performance, CRA/CRO oversight of clinical sites and ensuring study conduct is consistent with GCP/ICH guidelines. Managing Data Safety Monitoring Committee meetings. Overseeing issue resolution / escalation and management of vendor budgets and set-up/maintenance of the trial master file. Develops and maintains study management tools.
• Study Completion: Database lock and study completion (final clinical report, trial master file completion). Preparation for site and sponsor Regulatory audits, clinical site and vendor shut down.
• May directly manage one or more clinical operations teams (CTMs, CRAs, CTAs, other operational staff).
• Financial Management of one or more clinical programs in conjunction with Finance and Strategic Sourcing Departments. Responsible for risk assessment of project objectives against actual activities to evaluate any significant impacts on time, cost or deliverables.
• Identifies new systems and processes to create efficiencies in clinical trial management.
• Mentors, trains and serves as a resource for other Clinical Operations staff.
• Performs other functions as necessary or as assigned.
  
  

Requirements:

• Proven experience as an AVP, Sales or similar leadership role leading a salesforce of 50-100 people
• Minimum of 8 years’ sales management experience in the pharmaceutical/biotechnology industry
• Recent experience launching products with demonstrated success on consistently meeting and/or exceeding sales objectives and goals
• 2-3 years of direct account management experience with a history of proven past performance that has met and exceeded expectations.
• Successful experience in fast-paced entrepreneurial environment
• Extensive network in Pharmaceutical, Biotech and auto-immune/rare disease industry
• Bachelor of Science degree in life science, biology, business, or marketing, with an MBA preferred
  
  

Skills:

• Bachelor’s Degree required
• At least 7 years clinical research experience
• 5-7 years Vendor management
• Demonstrated success in domestic/global trial management
• PMP Certification an asset
• SOCRA (CCRP) Certification an asset
  
  

Knowledge & Skills

• Proven success managing all aspects of domestic and international clinical trials from study start to final report.
• Experienced in management of multiple study vendors, developing site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
• Knowledge of the drug development process in the bio/pharmaceutical industry with an understanding of ICH/GCP guidelines, and relevant regulatory requirements.
• Knowledge of critical path construction and analysis.
• Understanding of financial principles, budget management and staff utilization.
• Demonstrated proficiency at building consensus when working within a team setting.
• Must have the skills to work with peers from different functional areas to facilitate team objectives.
• Demonstrated negotiation and persuasion skills.
• Enthusiasm for innovative research and ability and desire to learn new approaches and expand core skill set.
  
  

Desired Competencies:

• Being Resilient: Rebounding from setbacks and adversity when facing difficult situations
• Collaborates: Building partnerships and working collaboratively with others to meet shared objectives
• Communicates Effectively: Developing and delivering multi-mode communications that convey a clear understanding of unique needs and different audiences
• Customer Focus: Building strong customer relationships and delivering customer-centric solutions
• Decision Quality: Making good and timely decisions that keep the organization moving forward
• Drives Engagement: Creating a climate where people are motivated to do their best to help the organization achieve its objectives
• Drives Results: Consistently achieving results, even under tough circumstances
• Ensures Accountability: Holding self and other accountable to meet commitments
• Instills Trust: Gaining the confidence and trust of others through honesty, integrity, and authenticity
• Plans & Aligns: Planning and prioritizing work to meet commitments aligned with organizational goals
• Self-Development: Actively seeking new ways to grow and be challenged using both formal and informal development channels
• Values Differences: Recognizing the value that different perspectives and cultures bring to the organization.
  
  

Additional Information

All candidate information will be kept confidential according to EEO guidelines.