11 sr product manager jobs found

Biogen About This Role PV Scientists are responsible for assigned tasks for designated products or product groups. Reporting to a Sr. PV Scientist or above, the PV Scientist will serve either as a lead PV Scientist or supporting PV Scientist, depending on his/her assigned product or product groups. Irrespective, the PV Scientist is a critical team member whose responsibilities include performing signal management activities, authoring safety evaluations, contributing to aggregate report planning / authoring, responding to ad hoc regulatory responses, conducting safety literature reviews, and serving on clinical trial safety teams. The PV Scientist, with oversight from their manager, will serve as a Subject Matter Expert for the Global Safety and cross-functional team on relevant global safety regulations and guidelines, data output and analyses, and product information. This position is Hybrid based out of our Cambridge, MA office What You'll Do Collaborates on the...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Vice President, Biostatistics, the Senior Biostatistics will serve as the project lead statistician responsible for statistical activities at study level and compound level, including, protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations at Nuvalent. The Senior Director, Statistics will also oversee CRO statistics deliverables for all Nuvalent studies. Responsibilities: Lead the development of statistical sections of clinical study protocols, statistical analysis plans, and conduct the analysis...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Vice President, Biostatistics, the Senior Biostatistics will serve as the project lead statistician responsible for statistical activities at study level and compound level, including, protocol development, study design, statistical data analysis, regulatory submissions, publications, and presentations at Nuvalent. The Senior Director, Statistics will also oversee CRO statistics deliverables for all Nuvalent studies. Responsibilities: Lead the development of statistical sections of clinical study protocols, statistical analysis plans, and conduct the analysis...

Merck Job Description The Materials and Biophysical Characterization group in Analytical Research and Development is seeking a highly self-motivated and innovative scientist with deep knowledge and strong problem-solving skills in biophysical characterization. The Biophysical Characterization team is responsible for building the mechanistic understanding of the interplay between formulation composition, process and stability of drug substance and drug product to ensure process robustness and product quality. As a Senior Scientist, you will be supporting projects in the diverse pipeline by developing and implementing biophysical and particle characterization assays collaborating with process, formulation and device as part of the CMC development team. You are expected to use your scientific expertise to find creative solutions to challenging problems which require deep analytical insight and critical thinking. Additional responsibilities include authoring technical reports...

Biogen This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...

Biogen This is a remote position that requires the candidate to be located in the United States. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management....

Merck Job Description Sr. Scientist, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development group has an opening for a Senior Scientist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. In your role as Senior Scientist, you will be part of a team developing innovative analytical methodologies for early to late phase programs with application to drug substance and a broad array of drug product dosage forms, combination products and modalities through analytical characterization, imaging tools, and data analysis. You would also...

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Biogen About This Role As a Sr. Engineer III in Manufacturing Sciences, you will be an integral member of the global Manufacturing Sciences team. Your primary focus will be on leading, facilitating, and coordinating biologic molecule technology (tech) transfer activities at our Bio Site in RTP. You will create, drive, and communicate technology transfer deliverables while managing the overall tech transfer schedule and metrics. By utilizing technical rigor, analyzing complex issues and identifying business process optimization opportunities, you will provide technical leadership, strategic insights and direction. Your role also involves communicating transfer plans and risk mitigations to senior leadership, ensuring alignment with departmental priorities. This position is pivotal for driving successful tech transfers, supporting both internal programs and those of our strategic partners, and enhancing the value to our business What You'll Do: Coordinate and lead tech...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...