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Regeneron Pharmaceuticals Associate Director, Clinical Transparency & Trial Disclosure in United States

The Associate Director of Clinical Transparency and Trial Disclosure (AD, CTTD) is responsible for driving technical innovation and providing operational and strategic support across the Clinical Transparency and Trial Disclosure (CTTD) organization. In this role, you will be expected to develop and implement new transparency and disclosure related process tools and technologies, help monitor and assess regulatory transparency changes, drive change management and communication, and assist with transparency and disclosure work, as needed.

In this role, a typical day might include:

  • Collaborating with team responsible for clinical trial registration and results disclosure to manage and develop associated technology systems and tools

  • Partnering with Data Transparency team to assess trends, create tools, and implement novel technology solutions to help standardize and streamline the identification of Personal Data (PD) and Commercially Confidential Information (CCI) in clinical and regulatory documents that will be publicly disclosed

  • Identifying new trends and ideas through proactive learning and monitoring of transparency landscape

  • Creating and maintaining structured sources of transparency and disclosure data and metrics

  • Assessing regulatory updates to determine impact to the CTTD team and manage associated change in collaboration with CTTD leaders

  • Performing document redaction and anonymization, QC, clinical trial registration, and data sharing activities, as required

  • Collaborating with Global Development-IT and external vendors on system related activities such as establishing user requirements, performing validation activities, reviewing documentation, tracking new functionality, and roadmap planning

  • Managing ad-hoc projects and representing CTTD team on cross-functional initiatives and working groups

  • Serving as a strategic leader and technical expert for the CTTD team by applying technical knowledge to solve complex issues

  • Providing leadership with input about team goals, strategies, and initiatives

This role might be for you if can/have/are:

  • Strong planning, communication, and project management skills, along with initiative and ability to proactively identify opportunities for improvement

  • Flexible; adapts work style and product to meet organization needs

  • Collaborative and team oriented

  • Ability to contribute to multiple ongoing projects simultaneously

  • Ability to be strategic while contributing and executing

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

  • Minimum Bachelors Degree with 7+ years in the biotechnology/pharmaceutical industry; experience in clinical transparency and/or disclosure required

  • Demonstrated understanding of global regulatory requirements for clinical transparency and trial disclosure

  • General understanding of Artificial Intelligence (AI) and machine learning and the associated limitations

  • Demonstrated ability to streamline established processes using technology and passion for implementing technical solutions to solve business challenges

  • Expert computer skills including proficiency in MS Office, Adobe, Regulatory Document Management Systems, and common industry disclosure systems

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$151,800.00 - $247,800.00

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