Associate Director Clinical Operations

Our mission All new medicines need to undergo clinical trials to show they’re safe and effective. But today’s clinical trial infrastructure is stuck in the past, and the cost of developing new medicines has skyrocketed as a result. Patients have to wait longer and pay more for new treatments. Our mission is to fix this; we use software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. We’re still a young company, but we’ve already had a big impact. Since founding the company in March 2021 we’ve helped run over 100 clinical trials involving tens of thousands of patients, with a customer NPS of 100. We recently raised a $55m Series B round from Balderton Capital, with support from Creandum, Firstminute, Seedcamp, and Visionaries. About the role We’re looking for someone experienced in implementing the full trial life cycle for multi-site and/or decentralized trials, who can bring a creative and proportionate approach to trial creation and delivery. The ideal candidate will have a deep understanding of regulations including ICH GCP and FDA/EMA/MHRA regulatory requirements to help ensure best practice and to successfully lead, train and support trial teams. Experience across a variety of disease areas of Phase I-IV trials, complex trial designs, interventional, medical device and drug trials experience is essential. This is a pivotal role as you will also be supporting the scale-up of our clinical operations team. You will also support our Product and Solutions teams in enhancing our product and winning new business. You will work closely with the US Director of Clinical Operations, the VP of Clinical Operations, the Associate Director(s) of Study Management and the global Clinical Operations team. About you

• 10+ years experience in Clinical Operations, implementing and successfully delivering trials
• Good experience and understanding of ICH GCP and FDA/EMA/MHRA regulatory requirements
• Experienced team leader
• Previous startup/biotech experience is a plus
• Understands commercial aspect so has experience of collaborating with Sponsors, vendors and business development
• Experience of creating and implementing regulatory compliant proportionate processes
• You have high agency and a bias for action
• You are passionate and curious about our mission; changing how the healthcare industry operates and how new health treatments are developed
• You want to learn what life is like at a high-growth, mission-driven VC funded startup

You belong here! If your experience and interests match with some of the above, we want you to apply. What you’ll focus on Project Leadership and Delivery

• Oversee the day to day running of clinical trial programs and projects, ensuring that they deliver successfully (i.e., conduct trials on time, on budget, in compliance, and of high quality)
• Advise on development of Study Management scope and activities to improve efficiency and enable robust interfaces and/or execution.
• Create and maintain optimal working practices, SOPs, systems and tools, to ensure robust Study Management execution and stakeholder communications.
• Where necessary ensure project continuity through key transition events and staff absences
• Coordinate activities and deliverables of all project conduct and proactively identify and manage issues

Reporting and Communication

• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files
• Provide oversight for development and implementation of project plans in accordance with Lindus Health Controlled Documents
• Independently prepare, coordinate, and present project material at internal and external meetings
• Direct the activities of assigned Project Support staff and mentor other project management team members and clinical staff; facilitate team building and communication
• Implement resource strategies to achieve project goals
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of project goals

Training

• Facilitate team training reflective of current best practice and process training

Business Development

• Support business development work with Sponsors and vendors where necessary
• Pivotal role in the seamless handover/set-up of projects from Business Development to ClinOps

Product

• Work closely with the tech and product teams to help design best-in-class trial technology that exceeds customer demands (e.g., EDC, e-Consent, eTMF)
• Collaborate to develop formal study requirements that enable rigorous validation of clinical trial software, and contribute to the development and maintenance of our SOPs and policies

What we offer Make an impact across all areas of our business and fix one of the world’s most broken industries.

• Competitive salary, plus meaningful stock options
• Unlimited holidays; everyone is encouraged to take off at least 28 days each year
• Health insurance coverage through our PEO Trinet
• $40 monthly wellness allowance, which you can spend on a wellhub membership, or wellness activities and expenses of your choice!
• Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver
• $2,000 Learning and Development allowance each year to put towards courses, certifications, and development
• Regular whole company and team events, both in person and virtually.
• Access to gym and retail discounts through our benefits platform Happl
• Monthly lunch voucher for our remote teams
• Charity events and fundraising opportunities through our charity partnership with the Forward Trust

Our hiring process

• Initial conversation with our Talent team (30 minutes)
• Second meeting with a Senior Leader of our ClinOps (30 minutes)
• Functional interview with two Senior Leaders of our ClinOps team (45 minutes)
• Values interview with a Cofounder and VP Clin Ops (30 minutes)

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