Shire Group Lead Bioanalytical & Biomarker Development in Cambridge, Massachusetts
We are seeking a highly motivated & collaborative senior leader to join our Bioanalytical & Biomarker Development department (BBD). The BBD dept. within Shire is responsible for bioanalytical and biomarker strategy and assay development, support of late research through preclinical and clinical development including life-cycle management.
The major focus of this role will be to provide leadership to a team of senior level scientists who are engaged in supporting non-clinical and clinical development of early to late stage clinical programs across multiple modalities of biologics including gene therapy. The team is responsible for developing Biomarker and bioanalytical strategies and assays (including PK, Immunogenicity and biomarker assays). The person in this role will supervise and provide mentorship to a group of approx. 6-8 people ranging from very experienced to junior scientists involved in supporting a variety of rare diseases with an emphasis on biologic replacement therapies including Hemophilia and other rare diseases.
The successful candidate will have demonstrated experience with Immunogenicity and PK assay practices in support of biologic clinical development, regulatory guidelines associated with these assays and experienced in interacting with regulators. Experience in generating immunogenicity risk assessment plans, familiarity with risk prediction and mitigation approaches and analysis of data and interpretation is required. In addition, experience in solving technical issues via novel approaches including developing new solutions, intimate knowledge of clinical trial support, experience in working CROs, ability to pay attention to detail, ability to manage multiple projects to meet aggressive timelines are required skills. Familiarity with biomarker applications/assays and implementation in a clinical program is a plus. Demonstrated supervisory experience, developing and mentoring people is a must. Experience and familiarity with GLP, GCLP guidelines are required. Experience with CLIA environment is desirable.
May also participate in core project teams, lead sub-teams, and develop biomarker strategies as applicable for stage of development. Maintain knowledge of a specific therapeutic area, interface with internal stake holders such as other BBD scientists, project team reps, DMPK, preclinical & clinical pharmacology, Research TAs and Toxicology, clinical operations stake holders. Role may also interface with external KOLs, and scientific organizations as relevant based on the project scope and goals.
% of Time
Be responsible for managing the BBD team of scientists, oversee, manage the development & implementation of biomarker and bioanalytical strategy in support of the Shire drug programs (with initial emphasis on Hemophilia Franchise), provide appropriate technical advice and support to scientists in the team. Bring forward and employ innovative technologies as necessary to bring novel solutions to accelerate clinical development. Author, review relevant reports and documents required for regulatory submissions.
Partner with BBD management and LT team to develop efficient processes execution of business activities that include developing systems and processes related to Bioanalytical area expertise, management of CRO relationships.
Work with CRO laboratories to develop/transfer, validate, and support assay implementation. Work with internal BBD colleagues and compliance dept. to ensure the analytical work is performed according appropriate regulatory and GLP/GCLP guidelines.
Provide leadership to staff within his or her functional group to enable group members to perform their best. Develop people.
Education & Experience Requirements
Ph.D. in Immunology or cell/molecular biology or a related field. Experience in product development related to Hemophilia/Hematology is a plus. At least 12-15 years of experience in the development, application bioanalytical assays with emphasis on immunogenicity assays (immunoassay platforms and molecular assays) in preclinical and clinical drug development required. Experience with immunogenicity prediction ( in silico and in vitro ) approaches and or flow cytometry based assay experience is desirable. Experience in Bioanalytical practices, GLP and GCLP guidelines/practices, working with cross-functional teams, project representation experience, and management experience required.
Demonstrated leadership abilities, management and communication skills (written and verbal) is a must. Demonstrated ability in applying innovative approaches to problem solving is a plus. Demonstrated project representation/leadership experience is required.
Key Skills and Competencies
Strong analytical skills, experience in assay development, validation and problem solving skills as applicable in the drug development area.
Demonstrated experience in successfully developing/employing immunogenicity risk assessment strategies, immunogenicity and PK assays to support biologic drug development is essential. Expertise in immunogenicity prediction methods is a plus
Experience or familiarity with biomarker assays is a plus.
Experience in application of a variety of technologies, data analysis packages such as Prism, JMP, and other tools to analyze a variety of analytical data.
Ability to author reports and regulatory documents
Ability to manage teams of experienced scientists and working collaboratively with others within and outside the department.
Flexible team player
Complexity and Problem Solving
Expected to plan and make decisions related to day-to-day operation of his/her own functional area, plan and manage timelines and resources.
Project and plan for resources and budgets including travel and program support.
The decisions that may impact the broader BBD or NCD organization should be consulted with or deferred to management.
Other Job Requirements
May include some travel to CRO laboratories occasionally based on need.
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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.