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Shire Director - Bioanalytical Study Management in Cambridge, Massachusetts
We are seeking a highly motivated and experienced Bioanalytical Study Manager to join our Bioanalytical & Biomarker Development department (BBD) and build a newly created function of Bioanalytical (BA) Study Management. This new function will play critical role in managing bioanalytical and biomarker support of non-clinical and clinical development programs across the broad Shire portfolio.
This is an excellent opportunity for someone with significant amount of bioanalytical assay and preclinical & clinical study support experience to broaden their scope and influence across a wide spectrum of activities. Person in this role will provide leadership to the group by developing processes to manage multiple small and large molecule programs across several therapeutic areas ( approx.. 50 drug programs) through outsourcing to contract research organization (CRO) labs. The BA study management group will develop relationships with and serve as the key interface with our CRO partners externally and with internal stake holders such as clinical operations teams and QA function among others. This group will work in close collaboration with BBD scientists who are responsible for developing and validating the bioanalytical & biomarker assays.
The person in this role will work with Procurement and vendor alliance management personnel within Shire to develop partnership models and governance structure for working with our preferred providers. The person is responsible for recruiting and leading a team of BA study managers who will partner with BBD scientists to facilitate and manage interactions with CROs in order to effectively manage resource assignment at CRO labs so that project key milestones are met. To this end, the person in this role will be responsible for developing and implementing appropriate project management tools in order to manage timelines and deliverables for multiple studies and resources employed at CRO labs.
Based on the strong bioanalytical experience, the person in this role will be able to influence and prioritize any competing projects and resources in a fast paced environment in order to ensure all high priority timelines for data delivery and reports are met. The person in this role will also develop key interface with Shire QA&C dept. and manage the audits of our CRO providers and facilitate maintaining good standing status of each of our CRO providers.
Will be a member of the BBD senior leadership team and based on his or her experience will provide appropriate input into department level processes and represent BBD/NCD at appropriate forums including R&D Risk Management Council. The person in this role will provide supervision and mentorship to 4-5 study managers and support their career development.
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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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.