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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.
Boston Biomedical has recently implemented a Bayesian model-based approach in early phase oncology clinical trials. The company is seeking a PhD Level Biostatistician to enhance this initiative.
This position is responsible for quality and compliance oversight of manufacturing, packaging, testing and distribution in operations that support global distribution of BBI products including small molecules, peptides and drug delivery devices. This includes oversight of active pharmaceutical ingredient (API) manufacturing operations as well as dosage form manufacturing operations including capsules, tablets and aseptically lyophilized drug product. Familiarity with international current good manufacturing practices (cGMPs) for both drug and devices and other best practices for pharmaceutical manufacturing operations will be a critical component of this role. This Quality function supports early and late stage clinical programs as well as NDA filing and commercial drug launch. The role will partner with internal stakeholders to ensure that Quality supports CMC and other cross functional teams as well as the Company’s processes.
The Senior Manager / Associate Director of IT Engineering & Operations (E&O) is a hands-on technical/management role reporting to the IT Director of Infrastructure and Operations. The Senior Manager / Associate Director is responsible for managing and support of current Infrastructure technologies. 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.
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.
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.
The Executive Director, Head Clinical Research Scientist role is an exciting opportunity for a highly motivated individual to be a key contributor to the development and execution of the clinical strategy across the oncology portfolio. The Head of CRS will lead the Clinical Development Team, to support early and late stage clinical development to have a strategic and scientific impact on current and future clinical programs, building and leading a team of clinical research scientist with expertise to collaboratively design, plan, implement, analyze, and report clinical studies. This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.
Responsible for creating and leading a high performing Medical Affairs function.
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.
This position is responsible for quality and compliance oversight of manufacturing, packaging, and distribution for Boston Biomedical oncology products including small molecules, peptides and drug delivery devices. This includes oversight of active pharmaceutical ingredient (API) manufacturing operations as well as dosage form manufacturing operations including capsules, tablets and aseptically lyophilized drug product. Familiarity with international current good manufacturing practices (cGMPs) for both drug and devices and other best practices for pharmaceutical manufacturing operations is a critical component of this role. This Quality function supports early and late stage clinical programs as well as NDA filing and commercial drug launch. The role will partner with internal stakeholders to ensure that Quality supports CMC and other cross functional teams as well as the Company’s processes.
• 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.
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 Manager, Regulatory 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 the regulatory submission process. 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.
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.
• 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.
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 and Evaluation – External Innovation will 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 and not business development.
Manager / Sr. Manager, Pharmacovigilance Systems will manage and oversee the safety database, manage reporting and data outputs from the safety database and other activities to support the PV Department, as determined by PV Management.
We are seeking an experienced PV professional who can serve a dual role as Pharmacovigilance (PV) Scientist and a PV Operations Study lead to join Boston Biomedical Drug Safety & Pharmacovigilance. In this exciting and challenging role, you will work with the Program Safety Lead, PV Operations, and other PV Scientists and Physicians, and cross-functional team and play as a leading role in performing PV activities for your assigned drug programs(s). Your ability to work collaboratively will facilitate cross-functional engagement with colleagues from across the Boston Biomedical organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics.
The Senior Manager of Quality Control is responsible for lot release testing and Certificate of Analysis approval. This manager will oversee Boston Biomedical’s global contract testing laboratories in partnership with the Company’s CMC Team. They will be responsible for leading the Stability Committee and the Specification Committee for GMP Drug Substance and Drug Product programs. They will ensure compliance to applicable global laws and regulations and participate in compiling and reviewing analytical sections of the IND and NDA submissions. This role works with internal stakeholders and external partners to ensure Quality released drug supply and expiring dating in is available to support clinical programs and future marketed product launch.
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.
The Vice-President, Regulatory Affairs in partnership with the CMO and other key stakeholders will develop, operationalize and steward the Company’s global regulatory strategy and operational plans covering the full life cycle of registration and post marketing pathway for all pipeline products and commercial stage assets. The incumbent will build a high performing and collaborative regulatory team and serve as a player coach leader to advance the Company’s assets through the various regulatory stages.
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.