Conducts detailed analyses of clinical data. Must be resourceful and have outstanding abilities to synthesize and make connections • Helps to author the Clinical Study Protocol, amendments and related documents, Informed Consent Form, monitoring plan, and other key study documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility. • Participates in development of other key documents and reports for clinical programs • Contributes to decision-making and provides well-reasoned, thorough reviews, due diligence and proposals to cross-functional project teams. Engage in team discussions and provide translational sciences support for assigned projects • Conducts detailed literature reviews and analysis of competitive landscape from a technological, mechanistic, pharmacological and clinical development perspectives. Based on scientific understanding of technologies, diseases processes and targets of interest, provides analyses and rationale for early clinical development opportunities • Contributes to the development and optimization of the REGN’s indication knowledge-base to facilitate information

SUMMARY: Works closely with Associate Director, Precision Medicine and other key personnel to implement and operationalize Precision Medicine goals within each of Regeneron-sponsored clinical trials. Manages central laboratory and specialty vendors and evaluates new capabilities aimed at collecting clinical biomarker samples and measurements. Evaluates performance of vendors and collaborators, participates in vendor oversight activities and manages relationship with vendors. Liaises with investigators and key lab personnel to ensure smooth laboratory operations and timely data transfers. Presents at investigators meetings and creates training materials (Lab Manual, Sample Collection Procedures, presentation slides, etc.). Oversees database of clinical samples, associated informed consent agreements, and destruction dates at a single sample level. Designs data transfer plans and maintains data integrity. Performs other duties as necessary to ensure optimal clinical trial execution.

Works closely with Head, Predictive Medicine and other key clinical personnel to ensure that Pred Med goals are executed with each of Regeneron's clinical trials. Engages vendors and evaluates new capabilities aimed at collecting clinical samples and measurements. Engages investigators and key lab personnel to ensure smooth laboratory operations and timely data transfers. Participates in Site Initiation Visits to train qualified personnel on the goals and procedures needed. Evaluates performance of vendors and collaborators and make recommendations on changes. Maintain a database of clinical samples and associated complex consent agreements and destruction dates for each sample. Perform other duties as necessary to ensure optimal clinical execution. Essential Duties and Responsibilities include, but are not limited to the following:• Tracks status of clinical trial samples designated for biomarkers, pred med and/or exploratory research. Develop a database to improve efficiency, if necessary.• Acts as a primary point of contact between internal clinical trial and sample management colleagues, vendors, and central labs to assist in issues regarding sample collection, processing, management and analysis.• Reviews external clinical laboratory bids to ensure they are consistent with the clinical protocol and other program needs.• Evaluate emerging technologies and vendors to consider for future programs (more experienced candidates may have the ability to perform this task).• Takes responsibility for coordination of events or liaising with vendors.• Analyzes issues and uses judgment to elevate issues to the appropriate team members for consideration and resolution. • Works within a matrix environment, collaborating with internal and external customers as needed to achieve program goals.• Attends Clinical Trial Management meetings to understand REGN processes and ensure harmonization regarding sample collection and processing across all REGN clinical studies.

* Support the Aliskiren biomarker team in coordinating biomarker samples in global cardiovascular clinical trials.* Ensure biomarker samples are collected as per the visit schedule, use of the appropriate assay kits, and shipped to the central labs according to the lab manual. * Work with clinical trial heads and clinical managers to ensure proper enrollment for biomarker studies.* Clinically evaluate blinded biomarker samples and compare each specified visit to ensure values are physiologically possible and reconcile with central labs for re-analysis of inconsistencies.* Summarize, review and identify novel biomarkers pertaining to the cardiovascular and metabolism system from scientific literature journals.* Perform literature searches and summarize findings in response to scientific questions posed by Health Authorities or internal clinical trial or management teams.* Streamline biomarker reporting by standardizing units and parameters.* Review lab data transfer specifications. * Taking the initiative in resolving issues with labs, which includes missing patient samples and missing data transfer specifications, when nearing database lock.

Inputs preliminary and follow-up information of serious and non-serious adverse events from electronic source documents into an adverse event database (ARISg).• Prepares, at minimum, 35 clinical narrative (CIOMS/3500A) cases on a daily bases when indicated and independently assigns MedDRA/WHO terms to adverse events while maintaining consistency with the global adverse event database.• Involved in project for streamlining case processing for Zyrtec Allergy; maintaining coding consistency and affiliate reconciliation. • Participates in adverse event database upgrades and projects.