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of Key Responsibilities Represent Clinical Pharmacology and provide PKPD support and guidance to clinical stage project teams. Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data Conduct PK/PD analyses to guide development decisions on project teams Provide PKPD input for regulatory submissions such as briefing do
Posted Today
Key responsibilities include oversight, mentoring, & management of Clinical Supply Chain (CSC) staff, clinical programs (early& late stage), GXP & technology forecasting systems, and engagement with CMO suppliers. Knowledge base includes solid experience and understanding of end to end clinical supply chain activities, systems knowledge (IRT, forecasting, planning, and si
Posted Today
of Key Responsibilities Develop, implement, and oversee Alnylam's Clinical Trial Oversight strategy in alignment with ICH GCP E6 and E8 Lead, direct, and support Clinical Trial Oversight Leads (CTOLs) in assessing CRO monitoring effectiveness across the portfolio Direct day to day work activities for FSP vendor for Clinical Trial Oversight Consistently manage oversight act
Posted 2 days ago
Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies Provide leadership and input into glo
Posted 2 days ago
Partner with all levels of the finance leadership team including Accounting, FP&A, Procurement, and the CFO to align on strategy and technology initiatives. Provide the strategic vision and business aligned, technical roadmaps for financial systems including SAP, Adaptive, Ariba, and related technologies. Act as a single point of contact for business systems within the Fi
Posted 5 days ago
of Key Responsibilities Identify targets/indications where Alnylam technology can deliver transformative medicines. Lead cross functional teams to identify and prioritize indications for targets within Research. Drive external interactions with key opinion leaders to develop indication and early clinical strategy and identify targets and diseases of interest. Help make pri
Posted 6 days ago
Management of the Contract Lifecycle, including but not limited to drafting, modification, execution, amendments, and renewal of Health Plan Value Based Agreement (VBA) contracts, IDN and GPO contracts, and Government contracts (i.e. Medicaid, VA , DoD) across a portfolio of products. Understand contracting strategies and maintain current knowledge supporting data structu
Posted 8 days ago
Be the senior strategic and operational leader providing a strong, clear voice for the drug safety program and have a clear next generation vision for Global Patient Safety and Risk Management Grow, direct, and support the operations of a global function supporting products from initial IND/CTA, through NDA/ MAA filings, to approval and post marketing Develop a platform w
Posted 9 days ago
Define and execute the data strategy and roadmap for Alnylam, aligning with the company's vision, mission, and goals. Develop and maintain the data architecture and data models that support Alnylam's data needs across various domains, such as clinical, commercial, finance, and manufacturing, etc. Define, implement and enforce data governance policies, standards, and best
Posted 12 days ago
In collaboration with Country Manager and Market Access cluster lead, lead and own the local pricing and reimbursement procedures in BeNeLux; Optimize pricing and access strategies for BeNeLux, while ensuring they are aligned with regional and overall enterprise priorities; Directly engage with external BeNeLux authorities and internal and external stakeholders as needed;
Posted 13 days ago
Takes the lead in building the local strategic marketing and brand plans and tactical plans Manages the implementation of local tactical plans (e.g. local marketing material, congresses, educational events, promotional events, customer outreach etc.) Develops account plans in line with country strategy in partnership with Country Manager and Medical Affairs team. Performs
Posted 13 days ago
of Key Responsibilities To develop, coordinate and run induction training programs for all field force, e learning and F2F programs including regular certifications Work with Brand Teams in the identification and development of key training outcomes that support Brand Plan execution pre and post launch Responsible for development and implementation of competency based skil
Posted 13 days ago
Lead the establishment, development, and lifecycle management of primary container (syringe), device, and combination product programs to support Alnylam's portfolio of products Interacts with clinical development partners (Clinical Ops, Regulatory, and Commercial) to provide expert development advice to assist the product teams Collaborate with expertise areas (Quality,
Posted 13 days ago
Provide finance leadership for the company's alliances on both recurring deliverables (budgets, forecasts, variance analysis, etc.) and ad hoc efforts working in close partnership with R&D expertise areas, program teams, Alliance Management and other internal and external stakeholders. Track potential strategic and operational financial risks related to the company's alli
Posted 14 days ago
of Key Responsibilities Represents biostatistics at cross functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans. Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials. Writes the statistical sections of clinical trial protocols, while consultin
Posted 15 days ago
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