Senior Director/Director of Clinical Operations

About the company

 Leyden Labs aims to help people live their lives to the fullest. Our platform targets commonalities of viral families to protect humanity from known and future viruses. Our portfolio of accessible intranasal product candidates may provide people with the freedom to immediately protect themselves from and prevent the spread of many variants of respiratory viruses, including ones in the influenza and coronavirus families.

Job description:

Leyden Labs is looking for a Senior Director/Director of Clinical Operations who will drive the successful execution of our clinical trials, including overseeing team members and CROs. You will be accountable for providing strategic operational leadership including expertise and oversight over one or more clinical programs driving financial planning/forecasting, resource and budget planning and management, and development and implementation of department initiatives. This role plays a critical part in advancing our trials and getting a step closer in the development of our product(s).

More about the team:

The Senior Director Clinical Operations will report to the Chief Medical Officer and be a key member of the Clinical Development leadership and manage the Clinical team consisting of two Senior Clinical Study Managers and a Clinical Trial Associate.

Why would you want to work with us:

With innovation at the forefront, Leyden Labs is on a mission to develop cutting-edge mucosal protection platforms designed to free people from the threat of respiratory viruses, such as influenza and coronaviruses. We are delighted to be at a pivotal moment in our journey having recently secured a further $70M in funding. Working at Leyden Labs will give you the opportunity to work with a group of talented people and immerse yourself in truly meaningful medical science.

Responsibilities:

• Serve as the senior clinical operations lead for all programs within Leyden Labs that include early to late stages from First-in-Human to efficacy studies in influenza and coronaviruses as well as other future programs
• Support and supervise the selection, oversight and management of CROs and other vendors.
• Provide leadership in developing strategies for the successful conduct of clinical trials. Able to see the big picture, and with high-level of critical thinking to adapt and devise alternative plans to overcome challenges. Able to empower team to work through obstacles.
• Actively identify program and cross functional risks, develop and executes risk mitigation plans
• Provide oversight of budget forecast and financial activities for the clinical programs.
• Supervise and motivate study team members to reach set goal. Develop skills of junior members.

Job requirements

• Minimum BA/BS in scientific or health-related field.
• Minimum of 10+ years of clinical operations experience in the pharmaceutical/biotech industry including line management experience.
• Experience in leading influenza and/or coronavirus programs.
• Experience in Phase 3 influenza and/or coronavirus clinical operations is preferred.
• Strong working knowledgeable of GCP/ICH guidelines.
• Experienced using Microsoft Office applications.

More about you:

• A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity.
• Possess a “can do” mentality and able to pivot rapidly and effectively when faced with challenges.
• Excellent leadership, organizational, and communication skills
• Critical thinking evaluation of process problems
• Strong work ethic

Ideally our new colleague starts in May of 2025, but we are willing to wait for the best candidate, we understand you have a notice period or already planned your annual leave. Depending on the geographic location of the candidate remote or hybrid working are possible for this position. At this time we are only considering candidates currently residing on the US East coast or in Europe.

We are an equal opportunity employer; we firmly believe in the added value of a diverse and inclusive group of people with one common goal. We are looking for people who can make an impact and work on a purpose together.

If the purpose of this role and our company ticked all the boxes for your next adventure, please hit the application button and let me know you’re interested by sending me a short cover letter and your cv and I will get in touch within 5 working days (taking into account different time zones) to plan a first call.

Note to all agency recruiters given the important work our employees do, I kindly request that you do not disturb them by approaching our people directly. I’d love to hear from you at jobs@leydenlabs.com

Link to vacancy:

https://leydenlabs.recruitee.com/o/senior-directordirector-of-clinical-operations