Manager, Precision Medicine

Location
Tarrytown, New York, US
Posted
Aug 10, 2018
Ref
13960BR
Required Education
Associate Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
SUMMARY:
Works closely with Director, Precision Medicine and other key personnel to implement and operationalize Precision Medicine goals within Regeneron's clinical trials. Manages central laboratory and specialty vendors on clinical trials. Presents at investigators meetings and creates training materials (Lab Manual, Sample Collection Procedures, presentation slides, etc.). Supports and/or manages Senior Associates and Associate Managers to execute Precision Medicine goals. Performs other duties as necessary to ensure optimal clinical trial execution. Additional responsibilities for this position include data management expertise (including database management and general programming) and support. This part of the role will have responsibility for oversight of data transfer agreements, querying and visualization. Close collaboration with vendors, project management, clinical data managers and research colleagues is required to ensure that data management functions within the responsibility of Precision Medicine are performed to meet business needs and in compliance with regulations.

JOB RESPONSIBILITIES:
Study Team Support

• Participates in cross-functional study teams and sub-teams.

• Manages acquisition of clinical trial samples designated for biomarkers, precision medicine and/or exploratory research under supervision of more senior personnel.

• Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders.
Operational Support of Biomarker and Exploratory Analysis

• Assists Precision Medicine Scientists by assessing vendors, forecasting the biomarker sample operational costs, and reviewing invoices.

• Provides input on biomarker sections in clinical trial-related (such as protocols and consents) and other supporting documents under supervision of Director.
Selection of Central Laboratory and Specialty Vendors

• Prepares RFPs, reviews and assess bids and SOWs.

• Coordinates capabilities presentations by novel vendors.

• Attends conferences to identify new methodologies and technologies.
Central Laboratory and Specialty Vendors Management

• Takes responsibility for coordination of events, liaisons with vendors, and communication with academic collaborators.

• Participates in oversight activities with vendors and supports audits as required.
Data Maintenance and Management

• Provide general programming support for streamlining processes regarding data management and storage for precision medicine objectives.

• Provide database management, ensuring data quality from internal and external sources and producing analysis ready files.

• Ensure databases are validated and ready for transfer and/or analysis and manage data clean-up process performed by vendors from study start-up through data archiving.

• Be able to compile data sets from diverse file formats and databases and link them in a logical format.

• Supports information exchange and maintain data integrity.

• Provides guidance and training to clinical sites, collaborators and vendors to enable transfer of biomarker and exploratory data under supervision of more senior personnel.

• Contribute to data management outsourcing strategies and build relationships with partners/stakeholders with the objective of ensuring data quality and efficiencies through data and process standardization.

• Supports sample and data reconciliation activities.
Compliance Maintenance in Collection and Processing of Human Biospecimen

• Provides guidance to clinical study teams and clinical sites regarding collection and storage of biospecimen acquired in the course of clinical trials under supervision of more senior personnel.

• Works with ICF Specialist and Precision Medicine Scientist to ensure compliance with ICF permissions.

JOB REQUIREMENTS

• Working knowledge of the clinical drug development process

• Effective problem-solving skills

• Excellent written and verbal communication and presentation skills in small and large group settings

• Science background and working knowledge of a wide array of biological assays including proteomics, cellular assays, genomics, etc.

• Understanding of bioethics of human biospecimen collection and research

• Ability to effectively multi-task and prioritize

• Ability to work in a matrix environment

• Project management/organizational skills

• Interpersonal skills

• Cross-functional and cross-cultural awareness

• Excellent computer skills including Microsoft suite and Microsoft Access

• Understanding of relational databases and experience working with complex data systems

• Strong understanding of reporting systems utilizing multiple data delivery applications

• Strong background in data management, expertise in SAS/R desirable

• Laboratory research experience desirable.

EDUCATION

• B.S degree - Major/ Minor (Biology, Biochemistry or equivalent)

EXPERIENCE

• 8-10 years pharmaceutical industry experience.
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This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.