Current Opportunities

Ready to have an impact? SDP Oncology is hiring for the following positions.

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Associate Director, Clinical Operations

Responsible for maintaining and managing a highly skilled, stable and functional in house monitoring team to meet the developing needs of the Global Oncology business and developing and rolling out new monitoring processes and work instructions to best implement consistency and efficiencies.

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Associate Director, Pharmacovigilance Operations

Associate Director, Pharmacovigilance Operations will work on projects and processes that ensure the strategies of the department are executed within global safety legislation and requirements. To do this the Associate Director, Pharmacovigilance Operations will be responsible for activities within PV Operations and Compliance, as well as support Medical Safety, as needed.

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CMC Project Manager

The CMC Project Manager will be responsible for managing the development plan and CMC department efforts as it relates to the product development lifecycle.

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Director of Forecasting

The role of Director of Forecasting is to manage the design and execution of global forecasting capabilities to support decision making and strategy development for oncology assets in all phases of development (Pre-clinical, Phase I – III) and Business Development opportunities. Responsibilities also includes planning and management for in-line brand forecasts, tracking performance, and presenting insights to cross-functional teams and senior management.

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Director of Program and Alliance Management

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.

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Director, Regulatory Affairs

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.

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Director/Senior Director Program 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 in the area of oncology drug development. 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 Global Development Team members, will drive program strategy and ensure clear and timely communication of program strategy, implementation plans, and progress.

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Director, Regulatory Affairs CMC

The Director, Regulatory Affairs CMC will act as a CMC regulatory representative to develop CMC regulatory strategies, submissions and compliance activities.

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AD/Director, Statistical Programmer

This professional will function as the lead for statistical programming process improvement, CDISC SDTM/ADaM data standardization. He/she will enforce the appropriate standards in the department and provide training. Other responsibilities include 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.

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AD/Director, Statistical Programmer

This professional will function as the lead for statistical programming process improvement, CDISC SDTM/ADaM data standardization. He/she will enforce the appropriate standards in the department and provide training. Other responsibilities include 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.

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Executive Director Regulatory CMC

The Executive Director, CMC Regulatory Affairs, will be responsible for and providing leadership in all Regulatory Affairs functions relating to Technical, Manufacturing and Quality Operations for development and marketed products. The position will involve writing, reviewing and filing regulatory submissions and have a key role in relevant communications and meetings with Regulatory Authorities.

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Manager, R&D IT

The Manager, R&D IT will work closely with IT and members of the Research and Development organization to identify and deliver technology solutions that meet current and future needs of the organization. This role requires strong business analysis and collaboration skills, and a deep knowledge of business process and applications within Life Science’s Research and Development, primarily Quality Assurance, Regulatory Affairs/Operations and Pharmacovigilance. This individual will work closely with R&D leadership to understand business goals, objectives and operations, and develop IT strategy to meet the needs of the business. This role will collaborate with solution vendors, BBI IT Infrastructure and BBI Quality Assurance as necessary for implementation and other services.

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Manager, FP&A (Development and Discovery)

Responsible for maintaining and managing a highly skilled, stable and functional in house monitoring team to meet the developing needs of the Global Oncology business and developing and rolling out new monitoring processes and work instructions to best implement consistency and efficiencies.

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Manager, FP&A (Sales and General and Administrative (S,G&A)

Responsible for maintaining and managing a highly skilled, stable and functional in house monitoring team to meet the developing needs of the Global Oncology business and developing and rolling out new monitoring processes and work instructions to best implement consistency and efficiencies.

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Principal, Statistical Programmer

• 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.

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Senior Clinical Data Manager/Associate Director, Clinical Data Management

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.

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Senior Director – Human Resources - ONCOLOGY

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.

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Senior Medical Director, Translational Medicine-Oncology

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.

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Senior Administrative Assistant

Provide administrative support to the Chief of Staff and other designated executives including CEO & Global Head of Oncology, Global Head of Development & CMO, and Global Head of Corporate Strategy & Planning.

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Senior Clinical Project Manager

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. This professional may supervise junior level Project Managers.

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Senior Clinical Research Scientist

The Clinical 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 for one or more oncology programs. Through extensive interaction with the Clinical Development Team, this role will have the opportunity 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. This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.

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Director, Senior Director Medical Writing

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.

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Sr. Director, Scientific Search & Evaluation - External Innovation

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.

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Senior Manager, Quality Management Systems, Quality

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.

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Senior Medical Director, Pharmacovigilance – Early Stage

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.

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Vice President, Head of Translational Medicine and Early Development

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.

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