Flatiron Research was started in 2014 with the goal of serving cancer patients by accelerating research. We believe that existing clinical research paradigms are ill-equipped to answer the research questions that face drug developers, academic researchers, and regulators in the oncology space today. By focusing on technology solutions that can be deployed widely across the Flatiron network of providers, Flatiron Research has the opportunity to generate insights that were previously impossible.

To that end, Flatiron is seeking experienced clinical operations leaders to define and drive clinical trial management efforts to build a first-class clinical operations team focused on deliver high quality data and and to ensure operational efficiency.

Responsibilities:

The Head of Clinical Operations will be responsible for the operations of Flatiron’s research products. Specifically:

• Think of innovative ways to deploy people, process and technology to disrupt the way clinical trials are run - with a goal of obtaining better clinical insights more quickly.
• Conducting high-quality clinical research with our customers and partners from biopharma and academic medical centers.
• Being the thought leader that defines the vision for the Clinical Operations functions within Flatiron. Setting strategic direction and priorities for each function based on Flatiron’s needs.
• Building and developing the teams that conduct high-quality research at Flatiron.
• Recruiting and retaining extraordinary talent across all clinical research functions.
• Collaborate with other senior leaders to enable the overall success of the research business lines.
• Collaborate with other senior leaders to define Flatiron’s overall vision and strategy for building innovative new solutions for clinical research.
• Act as the subject matter expert (SME) to help define best practices for clinical operations
• Provide hands-on clinical operations support for specific studies (e.g. ensure that key milestones are met).
• Foster a culture of clinical operations excellence focused on meeting high quality, ethical and operational standards. Enhance and implement Flatiron’s clinical operations activities to ensure compliance with applicable regulatory requirements.
• Collaborate with our Product Management, Quantitative Science, Abstraction, Oncology and Software Engineering teams to advise on the correct application of internal and external requirements for clinical operations.

Requirements:

• 10+ years leading Clinical Operations or Clinical Development at a top Life Science company or CRO. Direct experience with multi-center, industry sponsored, interventional, clinical trials - preferably experience with global, phase III, oncology studies
• Desire to change the status quo and disrupt clinical trials but maintain the same quality standards defined by industry best practices - knowing where flexibility can be applied to enhance the process
• Deep understanding of clinical research projects, clinical trials & associated risks
• Extremely strong understanding of his/her own weaknesses and how to fill those gaps; self-aware, humble, motivated & curious
• Multiple years of experience with pharmaceutical companies; understanding of the complexity and organizational structure of pharma companies and how to navigate
• Extremely strong understanding of market strategy; ability to see how Flatiron’s products fit into the competitive landscape; ability to break down complex markets into components and develop strategy
• Excellent ability to understand the operational requirements to anticipate and fill in operational gaps early
• Ability to translate and infuse clinical operations knowledge and best practices for cross-functional teams
• Amazing people manager; experience leading groups of 20+ people; extremely thoughtful about management style, culture and leadership generally
• Experience operating on a leadership team with responsibility over a P&L

Bonus Points:

• Direct, hands-on experience with complex/novel study designs (e.g. adaptive, pragmatic, basket, umbrella, crossover trials)
• Management/oversight of technology partners for clinical trials (e.g. electronic patient reported outcomes [ePROs], sensors, electronic diaries, electronic data capture [EDC])
• Direct, hands-on experience with regulatory interactions (e.g. FDA meetings), regulatory submissions, post-approval commitments
• Experience with safety reporting/pharmacovigilance (PV) regulations