Associate Manager/Manager Precision Medicine Operations

Location
Tarrytown, New York
Posted
Apr 06, 2018
Ref
12929BR
Required Education
Bachelors 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 Manager/Sr.Manager, Precision Medicine and other key personnel to implement and operationalize
Precision Medicine goals within each of Regeneron's 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 and participates in vendor oversight activities. 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 clinical samples inventories 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.

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.
• Supports individual clinical study teams and biomarker sub-teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders.
• Analyzes biomarker- and sample management-related issues and uses judgment to escalate issues to the appropriate team members.
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 Associate Director.
Selection of Central Laboratory and Specialty Vendors
• Prepares RFPs, reviews and assess bids and SOWs.
• Evaluates emerging technologies and vendors to consider for future programs.
• Coordinates capabilities presentations by novel vendors and performs Functional Area Assessments.
• Attends conferences to identify new methodologies and technologies.
Central Laboratory and Specialty Vendors Management
• Manages relationships with central laboratory and specialty vendors including defining contracts and vendor oversight management, with the support of the appropriate study team members.
• 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
• 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.
• Supports sample and data reconciliation activities.
• Evaluates data integrity and communicates any potential issues to Precision Medicine Scientists, Data
Management and other internal/external stakeholders.
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 or other human sample acquisition projects.
• Works with ICF Specialist and Precision Medicine Scientist to ensure compliance with ICF permissions.
Process Development and Improvement
• Works within a matrix environment, collaborating with internal and external customers as needed to improve existing processing and identify a need for development of new processes.

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
• Working knowledge of ICH/GCP and regulatory guidelines/directives
• Working knowledge of CLIA/CAP regulations and GLP guidelines
• Therapeutic area knowledge
• Science background and working knowledge of a wide array of biological assays including proteomics, cellular assays, genomics, etc.
• Understanding of bioethics of human bio specimen collection and research
• Ability to effectively multi-task and prioritize
• Ability to work in a matrix environment
• Financial budgeting and forecasting skills
• Project management/organizational skills
• Interpersonal skills
• Cross-functional and cross-cultural awareness
• Excellent computer skills including Microsoft suite and Microsoft Access

EDUCATION

• B.S degree – Major/ Minor (Biology, Biochemistry or equivalent)
• M.S degree is a plus

EXPERIENCE

• 6 - 8 years pharmaceutical industry experience.

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.

Requisition Number: 12929BR