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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 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.
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.
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.
The Manager, Clinical Supply Chain is responsible for planning and support on multiple clinical programs working closely with Supply Chain project leads and Clinical Operations. This includes work on complex programs that may require multinational interactions. The position will collaborate closely with CMC subject matter experts, quality assurance, regulatory, and clinical operations to ensure compliant and timely supplies of clinical trial material are available to support clinical programs. The position will manage operational elements of Supply Chain projects/programs in a lead role, will analyze complex sets of data and apply appropriate methods to improve processes, and will influence and guide the Supply Chain team to execute on required activities in order to achieve strategic goals. May directly manage direct reports, but also operates as an individual contributor. May lead non-complex functional teams and initiatives.
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.
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 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.
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.