Associate Director, Clinical Development Innovation

This role is a hybrid position which means it is on-site 2 days per week and work from home 3 days per week.

The mission of Development Innovation at Regeneron is to modernize clinical development in order to bring new medicines to patients faster, at a lower operational cost, with better quality and experience for all. The Associate Director, Development Innovation will be responsible for identifying, evaluating, evangelizing, coordinating and leading innovation opportunities focused on clinical development operations speed and efficiency that can meaningfully improve the throughput of Regeneron’s clinical pipeline. 

In this role, a typical day might include:

Serving as a collaborator to internal and external partners to drive innovation across Global Development’s clinical platform.  The role will interact with drug development program and study teams, cross-functional leaders, industry consortia, external vendors and collaborators, and participate in efforts to quickly identify and get buy-in for ways to materialize high-impact opportunities to advance our study execution model.  They will also participate in innovation and transformation projects supporting the Global Development (GD) goals and strategy.

The role will also be responsible for advancing selected efforts through a stage-gate innovation funnel, including preparing proposals for senior governance review and advancing from concept through pilots, projects and proofs of concept to readying successful new innovations for scaled implementation.

Success in this role will require ensuring proper demand management, prioritization and serving as an match-maker and advocate for teams in the best use/implementation of new innovative capabilities, and identify risks and mitigations, forecasting and measuring the benefit to ensure value is delivered through the business capability for each study/program.  This role may also deliver on the roadmap by shaping the vendor capability set by sunsetting non-relevant capabilities/vendors and bringing on new ones. 

This individual will ensure Regeneron is at the forefront of innovative capability technologies and improvements, attend and be asked to present and represent the company at external industry forums. 

This role might be for you if have:

• Direct introduction and collaboration with internal study and program teams, functional groups, and other internal sources of innovation opportunities including problem identification, journey mapping, landscaping and solution ideation

• Develops business cases and project plans, including horizon-scanning and investing and incubating new and leapfrog concepts, gathering quantitative evidence and building financial models of return on investment (ROI) for operational innovation opportunities, to propose and drive new partnered initiatives forward across Global Development and other invested functions across Regeneron

• Shepherding onboarding of new potential external partners in new areas of capability, including close collaboration with Sourcing, Legal areas, Info Security, Vendor Relationship Management, Global Development Systems, Quality and other functions involved in new vendor onboarding

• Designing and launching pilots and pilot options, including stakeholder identification and management, risk identification & mitigation, project management, task development, tracking and execution for innovation opportunities and pilots

• Act as facilitator and connector between operational and technical stakeholders to achieve successful requirements definition, technology design and operational deployment, and identifies risks, trends, and builds corresponding mitigation strategies back into the process.  Technical stakeholders will also include Global Development Systems, Data Management, and other affiliated groups and functions

• Ensure adherence to existing business processes, standard procedures and technical instructions related to business capability ensuring compliance with regulatory requirements

To be considered for this opportunity, you must have the following:

• BS / BSc degree, or its international equivalent in clinical science or a health-related field from an accredited institution, or equivalent work experience required; Master’s level degree in a relevant field (e.g. MBA) highly desirable

• Minimum 10 years of experience in Pharma, Biopharma industry.

• Minimum of 5 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 2-3 years in a leadership position directing all or some innovative capabilities, process, program or quality activities

• Strong project management and planning skills; PMP, other formal training or equivalent experience highly preferred

• Knowledge of GCP/ICH guidelines, clinical trial regulations; Experience with mHealth best practices and principles

• Experience with regulatory requirements with regards to clinical development, including the key regulations from FDA, EMA and PMDA

• Experience in successfully managing and implementing transformative change, in addition to incremental innovation and change

•  Understanding of challenges and opportunities in managing processes, data and risks within clinical trials

• Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts

• Effective oral and written communication skills to influence, inform, or guide others

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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$165,900.00 - $270,700.00