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Shire Group Lead Bioanalytical Study Management in Cambridge, Massachusetts
Responsibilities (% of time):
Be responsible for building the newly formed BA study management function and provide leadership to the study management team; develop efficient processes for working with CROs, engage internal and external stakeholders in implementation and continuous improvement of these processes, management of priorities, resources, and study timelines. Partner with BBD leadership team to develop efficient processes for execution of business activities that include developing systems and processes related to area of responsibility, management of CRO relationships.
Develop partnership with clinical operations teams and ensure proper representation of BBD team members at CTTs. Author, review and appropriate BA study management-related documents e.g.: BA plans, reports, contracts, etc. and interface with clinical operations/medical writing and operations groups within NCD as required.
Identify and work with QA department to qualify and select CRO laboratories based on study support need. Work with CRO laboratories and BBD scientists to manage the transfer, validation of assays, and support assay implementation in studies at CROs. Work with internal QA& compliance (QA&C) dept. to ensure the analytical work is performed according appropriate regulatory and GLP/GCLP guidelines. Manage the audits and good standing status of CROs with the support of QA&C.
Provide supervision and leadership to staff within his or her functional group to enable group members to perform their best and develop people.
Ph.D. in analytical chemistry or a relevant field of biology with at least 10-15 years of experience in the development, transfer to CROs, and validation of bioanalytical assays to support preclinical and clinical sample analysis in drug development is required. MS degree in conjunction with demonstrated at least 15 years of experience in leading bioanalytical study management function is also considered. A business degree (MBA) or demonstrated project management experience is an added plus.
The person in this role will have demonstrated experience in bioanalytical assay and study support for small and large molecules. The person will be very familiar with practices in support of clinical development, regulatory guidelines associated with these assays. Should have extensive experience in clinical development support, working with BA CROs, attention to detail, organizational skills, able to manage multiple projects to meet aggressive timelines, be a collaborative & resourceful team player. Demonstrated supervisory experience, developing and mentoring people is a must. Experience and familiarity with GLP, GCLP guidelines are required. Experience with CLIA environment is a plus.
Demonstrated high initiative, leadership abilities, collaboration and project management skills, and strong communication abilities (written and verbal) are a must.
Key Skills & Competencies:
Strong management and leadership skills combined with analytical skills and past experience in bioanalytical assay development, validation and problem solving as applicable in the drug development area.
Familiarity with regulatory guidelines, ability to learn quickly the areas that are new to them.
Ability to see the big picture, hone in on the relevant details quickly and create both a strategic road map as well as an implementation plan.
Excellent collaboration and communication skills
Proactive approach to planning and managing resources/timelines
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.