Director, Clinical Operations

Key Responsibilities

• Strategic Oversight & Agility in Clinical Study Planning, Management and Execution
• Operational Excellence & Detailed Focus in Conducting Clinical Trials
• Timeline Management & Proactive Problem Solving in Executing Clinical Trial Programs
• Operate as a “Hands-On” Leader & Develop Teams in a Fast-Paced Environment

Qualifications

• A minimum of 10+ years of experience in managing global clinical trials at all stages of development
• Experience in immunological and dermatologic disease areas welcome
• Capable of managing direct reports from afar and study team members across multiple time zones and cultures
• Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
• Demonstrated successful management and oversight of CROs and other service providers
• Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings
• Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities
• Strong vendor management experience required
• Experience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.
• Experience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure
• Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities
• Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
• Strong project management experience and skills is preferred
• Demonstrate strong leadership, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environment
• Strong interpersonal, negotiation, influencing, problem-solving skills
• Excellent written and verbal skills required
• Willing to travel domestically and internationally up to 25% of the time
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Critical thinking, problem solving, ability to work independently
• Consistently operate with urgency, clarity and conciseness
• Communicate effectively and articulate complex ideas in an easily understandable way

Benefits

A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.

Pay

$213,000 - $240,000 USD

Schedule

Hybrid – onsite 3 days/week required