The following position is available in our Marlborough, Massachusetts corporate headquarters.
Director, Central Laboratory Services - Clinical Operations (Req. 10711)
Responsible for leading the Central Laboratory Services function within the Clinical Data
Management & Central Laboratory Services Department, Sepracor Drug Development. In
collaboration with other drug development functions, the Director will determine policy and
strategic planning that pertains to clinical trial operations. The Director is charged to
integrate good clinical practice as well as best operational practices into the overall drug
development plan by the selection, training, and coordination of outside resources, the
development of internal resources, and the establishment of process to assure that work
product within Clinical Operations & Data Analysis (CODA) maximizes value while controlling
In this position you will:
∑ Evaluate information from the clinical trial literature, government agencies, and outside
experts relevant to ongoing projects.
∑ Provide operational planning in all phases of drug development with an emphasis on
qualification, centralization and standardization of vendors, sample and data handling and
∑ Forecast clinical trial budgets with respect to the costs of central laboratory vendors and
hold multi-study contracts to recognize and leverage Sepracor business volume.
∑ Manage central laboratory vendor deliverables to Clinical Operations, Data Management and
∑ Collaborate with clinical project team to assure that clinical protocols meet regulatory,
logistical, and data requirements with respect to the collection of biological samples.
∑ Collaborate with functional areas outside of CODA to identify and standardize central
laboratory vendor deliverables.
∑ Conduct qualification audits of central laboratory vendors.
∑ Manage relationship between Clinical Pharmacology and Central Laboratory Services including
process improvement and standardization of sample collection.
∑ Develop Clinical Laboratory Services work guidelines and SOPs and, in particular, laboratory
procedures for clinical studies.
∑ Establish and manage a diverse resource pool of central laboratory vendors.
∑ Plan organizational growth and its direction in the area of Central Laboratory Services.
∑ Recruitment, development, and allocation of internal resources.
∑ Maintain expertise with regard to GCP, CLIA, CAP, ATS, CDISC, HL7, and 21 CFR Part 11.
Must have the ability to direct and mentor staff and requires that the candidate work closely
with other operational group leaders (e.g., Biostatistics, Clinical Project Management,
Clinical Monitoring Management, Clinical Research, etc.). Central Laboratory Services staff
will matrix into cross-functional drug development teams led by therapeutically focused,
Program and Medical Directors. In addition, Central Laboratory Services staff work closely
with the technical staff to define protocol specific supplies and packaging, manage timeline
and regulatory compliance, review and respond to Quality Assurance vendor audit reports, as
well as other related activities.
Bachelorís degree required; advanced degree in health or life sciences related to
pharmaceutical development preferred. 8+ years of pharmaceutical industry or other applicable
experience required, including regulatory submissions, project and proposal management,
supervisory responsibility, and targeted therapeutic knowledge. This position requires a
resilient individual able to work independently, with initiative, while exercising excellent
judgment. Outstanding written and oral communication skills are required as is the ability to
communicate appropriate material in a timely manner up, down, and across the organization.
Travel is an intrinsic job requirement.
For more information on Sepracor, please visit our website at www.sepracor.com To apply for
this position, please send your resume to email@example.com
Sepracor is an Equal Opportunity/Affirmative Action Employer.