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Boston Biomedical is hiring for the following positions. Job listings include title, job description, qualifications, and information about how to apply for the position.
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Associate Director, Regulatory Project Management is responsible for leading strategic planning and execution of the Regulatory and cross-functional teams to ensure regulatory deliverables (regulatory plans, health authority meeting execution, regulatory assessments) are achieved.
• Manage and coordinate the Statistical Programming staff to maintain work flow for programming efficiency. • Design, develop, evaluate and modify computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures. • Contribute to and champion best practices to enhance the value and contribution of Programming across other therapeutic areas.
The primary responsibilities of this position are to provide regulatory strategic input and oversight to the Global Development Teams on the development and implementation of device and companion diagnostics (CDx)s under development at Boston Biomedical Inc.
The Director of Program and Alliance Management position is a high impact, hands-on leadership role with responsibility for significant elements of program strategy and alliance management. This role requires a talented individual with proven expertise in scientific evaluation and portfolio management. With a focus across both academia and industry, the Director of Program and Alliance Management will also provide deep pre-clinical and/ or clinical scientific leadership to Boston Biomedical’s global sourcing of scientific innovation, partnership opportunities in the oncology therapeutic area, as well as leadership in the technical evaluation and due diligence of oncology in-licensing, acquisition, and/or NewCo formation opportunities at all stages of development, to feed our future pipeline. The focus of this role is on scientific evaluation, program management vs business development.
Lead the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia.
This position is responsible for quality and compliance oversight of Boston Biomedical oncology clinical trials with drug products including small molecules, peptides and drug delivery devices. This role includes oversight of Clinical Research Organizations (CROs), Local and Central Clinical Testing Laboratories, Biomarker Research and Diagnostics Laboratories, and Principal Investigator sites. Thorough understanding of international current good clinical practices (cGCPs), and good clinical laboratory practices (GCLP) for both drug and devices, as well as other best practices for pharmaceutical drug development is a critical component of this role. Quality support will be provided to internal and external groups performing pharmacovigilance, data management and data analysis. This Quality function supports early and late stage clinical programs as well as NDA filings and inspection readiness. The role will partner with internal stakeholders and external service providers to ensure BBI maintains the highest levels data integrity.
The Principal/Associate Director Biostatistician serves as lead statistician for one or more clinical studies. He/she works closely with the clinical team on the statistical design of the studies, and the analysis and data presentations for the studies.
• Function as a lead for statistical programming process improvement, CDISC SDTM/ADaM data standardization. • Enforce the appropriate standards in the department and provide training. • Responsible for planning and tracking the statistical programming activities such as designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety and efficacy analyses.
The Quality Assurance Manager would be responsible for administration and oversight of QA Document Management and Training. Experience in document management including authoring SOPs, electronic document management system maintenance. Collaborate with the business owners (GMP/ CMC, PV, Clinical, IT etc.) and provide guidance on Quality processes and to ensure successful execution through tracking, trending and general oversight for compliance.
The Senior Clinical Data Manager/Associate Director, Clinical Data Management assists the Senior Director, Clinical Data Management with data management activities in support of Boston Biomedical studies across all stages of clinical drug development. The incumbent ensures that clinical data capture, systems, and processes represent accurate, consistent, high quality, and complete data. Additionally, the incumbent impacts multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.
Partner with the VP HR & Administration and other HR colleagues to translate business priorities into HR plans and deliverables and provide operational HR support to Research, Development, Commercial and G&A groups. Support the building of a positive, engaged culture consistent with the company’s mission and values that work to assimilate the interests, talents, and contributions of its employees in a dynamic environment.
The Senior Medical Director will lead the direction, planning, execution, and interpretation of clinical trials activities of novel compounds, in various indications through early development to global regulatory submissions.
Reporting to the Head of Drug Safety & Pharmacovigilance (PV), the Senior Medical Director will provide hands-on and strategic leadership for Oncology PV activities associated with assigned Boston Biomedical investigational and commercial stage products. This individual will help build the PV Medical Safety group, and function in a company matrix team environment interacting with several key stakeholders, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, Medical Affairs, Quality Assurance, and Legal.
The Senior Clinical Research Associate (Sr. CRA) is a critical position within the Boston Biomedical Research and Development Operations team and is assigned as a "study lead" to manage clinical trial studies. The Senior CRA will partner with a Project Manager to support activities on complex/larger trials and will work collaboratively with internal and external team members supporting project team activities and ensuring all study deliverables are completed on time and within budget. The Senior CRA will work to manage, oversee and may monitor/co-monitor clinical trial sites.
The Director/Senior Director of Medical Writing is responsible for leading a centralized technical writing organization, while continuing to assess the writing needs across the R&D organization to support clinical regulatory submissions.
With a focus across both academia and industry, the Senior Director, Scientific Search & Evaluation will provide leadership to Boston Biomedical’s global sourcing of scientific innovation partnership opportunities in the oncology therapeutic area, as well as leadership in the technical evaluation (IND filing to clinic) and due diligence of oncology in-licensing, acquisition, and/or NewCo formation opportunities at all stages of development, to feed our future pipeline.
The Senior Financial Analyst on the Planning & Analysis team provides integral business partnership support to the functional departments, finance, and leadership team to execute the financial planning, forecasting, reporting and analysis process. This role facilitates financial reporting and analysis for Boston Biomedical’s leadership team, assists in the preparation of financial plans and forecasts based on Boston Biomedical’s strategy, and performs financial analysis and scenarios using appropriate financial concepts and techniques.
The Senior Manager, Quality Management Systems would be responsible for administration and oversight of select electronic quality systems such as Audit Management, Vendor Quality, Deviation and CAPA, etc. Provide support to the Quality Systems Group to ensure the CAPA, Change Control and Deviation processes deliver results efficiently and effectively. Experience in document management including authoring SOPs, electronic quality management system maintenance. Collaborate with the business owners (GMP/ CMC, PV, Clinical, IT, etc.) and provide guidance on Quality processes and to ensure successful execution through tracking, trending and general oversight for compliance. Manages the deployment of an electronic QMS System to support all Quality related activities including, but not limited to, deviations, investigations, product review and release, metrics and product quality complaints. Partners with internal stakeholders to ensure the e-QMS functionally supports cross functional teams and the Company’s processes.
The Senior Manager, Regulatory Affairs Strategy, CMC provides regulatory guidance and critical review of documents for global submissions to regulatory authorities while ensuring that submissions are in-line with the regulations. This position also supports the maintenance and regulatory compliance activities throughout the company. Assignments may include serving as the regulatory representative on project teams, managing the review and coordination of the quality submissions to support the filings and communicating changes of laws, regulations and standards. Additionally, this individual will act as the primary point of contact and be responsible for the management of any vendors which support regulatory submissions. In addition to assigned projects, responsibilities include the ongoing evaluation of processes and systems relative to industry best practices, resource management and ensuring compliance with evolving U.S. and international regulations and guidelines.
This role will be responsible for oversight of all activities to support the medical review of the clinical trial and post-marketing individual case safety reports (ICSRs) of adverse events and other safety information reported to Boston Biomedical, Inc.. This person will supervise the physicians (either in-house or with a vendor) who are medically reviewing adverse event and other safety information cases. He/she will work closely with the Boston Biomedical PV Operations and compliance teams to ensure timely completion of medical review in the larger context of case processing. He/she will work closely with the vendor for outsourced case processing activities, and may provide oversight of outsourced medical review, if applicable. Additionally, he/she will have regular and ad hoc communications with PV Safety Leads and/or the Head of Drug Safety & Pharmacovigilance regarding any medical or compliance issues.
The Head of Translational Medicine and Early Development will develop and execute translation medicine and early development strategy to effectively bridge preclinical and early clinical phases to improve overall success/speed of portfolio assets.