The Director of Clinical Operations will oversee the Clinical Operations team whose work drives the company to meet critical milestones in the Arthrosi clinical development programs.

Essential Duties and Responsibilities:

• Lead and supervise all activities related to clinical operations.
• Manage/oversee the conduct and execution of clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
• Partner with and supervise participating study sites and vendors to ensure studies are being conducted efficiently, effectively, and professionally.
• Maintain frequent and meaningful contact with CROs to assess performance and provide the necessary guidance.
• Manage budget and expense negotiations to ensure trials stay within budget while using resources efficiently.
• Supervise site selection process, playing key role in identifying and evaluating potential sites and vendors.
• Manage vendors including clinical and analytical CROs.
• Lead the development of study documents and tools, including study protocols, consent forms, project plans budgets, logs, templates, newsletters and other documents.
• Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training and other tools to ensure compliance with FDA Regulations.
• Responsible for implementation and oversight of Trial Master File for inspection readiness.
•  Lead training for clinical study teams on protocol-specific topics.
•  Provide study updates, inclusive of study risks and issues to senior leadership.
•  Proactively identifies project risks and works with necessary teams towards their resolution.
•  Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.
•  Responsible for ongoing data reviews and data cleaning activities
•  Provide oversight of CRAs and activities related to site identification, qualification, selection, initiation, interim monitoring and close out activities.
•  Support audits of sites and vendors.
•  Manage study supplies.
•  Ensure compliance with ICH/GCP and global regulatory guidelines.
•  Collaborate with other departments to ensure alignment of resources and budgets across the programs through evaluation of timelines and task prioritization.

Education, License, and/or Experience:

• Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
• Minimum of 10 years of clinical trial experience including clinical trial management and clinical monitoring in pharmaceutical, biotech or CRO setting; oncology study experience preferred.
• 3 years of experience in clinical program management.

Qualifications:

• Experience in Phase I-IV clinical trials, including global experience.
• Thorough knowledge of drug development, clinical operation processes and procedures according to ICH/GCP and other regulatory guidelines.
• Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
• Proven ability to manage multiple projects simultaneously in changing environment.
• Able to recognize need(s), find solutions, and take initiative to address in pro-active manner.
• Strong organizational and time management skills.
• Excellent communication skills, both oral and written.
• Strong team player with demonstrated track record of success in a cross-functional team and fast-moving environment.
• Proven ability to effectively collaborate with internal team and external collaborators.
• Self-motivated, comfortable working in a start-up environment where everyone pitches in to realize company goals, flexible, and innovative.
• Must have experience managing Phase I - IV trials, knowledge of clinical operations, ICH/GCP and FDA regulatory requirements.

Physical Demands

The physical demands here are representative of those met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; use hands to hold objects, writing instruments, the telephone, or files; talk, see and hear. The employee is frequently required to reach with hands and arms. The employee is required to stand and walk.

The employee must occasionally lift heavy items. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

Mathematical Skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compare rate, ratio and percent and to draw and interpret graphs.

Reasoning Ability

Ability to define problems, perform independent analysis, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in a mathematical or diagram form and deal with several abstract and concrete variables. Able to communicate effectively over the phone in a courteous and professional manner. 

Arthrosi Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.