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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.
The Clinical Research Scientist role will work within the Clinical Development Team and have opportunities to make strategic and scientific impact on current and future clinical programs, building clinical expertise to collaboratively design, plan, implement, analyze, and report clinical studies.
The Director of Biostatistics will be a key member of one or more clinical development programs who will be responsible for statistical aspects of clinical development of the program(s). Specifically, he or she will be responsible for the statistical decision making, innovative statistical design, modeling and simulation, and external collaborations on program level.
The role of Director of Market Research and Insights is to design and execute primary and secondary market research that spans multiple products and indication for the Commercial organization. This person will work closely with marketing and analytics to design strategic and tactical research plans to address business questions, inform strategy development and support portfolio planning. Responsibilities include planning and management of primary market research studies, integration of secondary data, tracking competitive landscape and presenting insights to cross-functional teams and senior management.
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.
The Program Director position is a high impact, hands-on leadership role with responsibility for significant elements of program strategy and cross-functional execution. This role requires a talented individual with proven expertise in leading global cross-functional teams and driving major initiatives. This individual, in partnership with the Program Team members, will drive program strategy and ensure clear and timely communication of program strategy, implementation plans, and progress.
Responsible for creating and leading a high performing Medical Affairs function.
In an virtual company environment, the Executive Director, Quality Assurance is responsible for the strategy, implementation & leadership of the Quality function at Boston Biomedical and is accountable for the execution and administration of the GXP Quality System pertaining to GMP, GLP and GCP and relevant ICH, US and EU regulations.
The Principal Biostatistician serves as lead statistician for one or more clinical studies. He or 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. 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.
Responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.
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/Principal Medical Writer is responsible for the medical writing deliverables that support the clinical oncology portfolio at Boston Biomedical Inc. The Senior/Principal Medical Writer will assist in preparing moderately complex clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure), and sections of regulatory submissions. As a key member of the Clinical Study Team, the Senior/Principal Medical Writer will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in the preparation of clinical regulatory documents.
Senior Director, Clinical Operations, will manage the successful completion of all IND to Post Approval clinical studies within appointed programs, as well as be responsible for assisting with the development of the program budgets and meeting both enrollment and spending targets. Manage and ensure competency of Clinical Operations staff including their knowledge and compliance with SOPs. The Senior Director, Clinical Operations will build and maintain relationships with clinical trial sites and principal investigators plus develop and maintain tools for tracking progress against department goals and objectives. The Director, Clinical Operations will participate in the strategy and development of new trials and participate in the selection of trial sites, vendor selection and management. The candidate selected will have strong leadership and teambuilding experience.
The Director / Senior Director of IT Infrastructure & Operations (I&O) is a hands-on technical/management role reporting to the Head of IT. The Director/Senior Director is responsible for managing current and future Infrastructure technologies and their development to support company growth. This individual will have a diversified background of technical infrastructure experience and skills, demonstrated project management acumen, excellent vendor management skills, plus a superior, service-oriented approach to infrastructure management. This individual will work closely with the IT management team and business units to implement effective solutions aligned with the company’s objectives.
With a focus across both academia and industry, the Senior Director, Search & Evaluation will provide deep preclinical 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.
Boston Biomedical, Inc.’s Human Resources team seeks a talented, hands on, creative, detail-oriented and highly organized self-starter to join its Cambridge, MA based growing and dynamic organization. In this newly created role, you will be responsible for delivering a diverse set of HR operational services to the company’s local and field-based employees in a manner that promotes operational excellence and strong employee engagement.
Generate or validate SAS data sets, listings, tables and figures, as well as supporting documentation (i.e. define.xml) for clinical studies. Enforce the appropriate standards in the department. 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.