Sr. Manager, Medical Research

Senior Manager, Medical Research - Value \u0026 Evidence Strategy, \n\nMedical Affairs\n\nOverview\n\nMedical Research designs and drives the operational strategy of medical affairs studies in order to generate robust real-world evidence that provides further insight on disease diagnosis and utilization, safety and clinical effectiveness of approved treatments.\n\nThe Senior Manager, Medical Research plays a key role in driving the generation of high\u2011quality real\u2011world evidence to support the clinical and scientific value of Alnylam\u2019s therapies. This role provides strategic and operational leadership for global, regional and local medical affairs research initiatives, including observational studies, collaborative research, Phase IV studies, and registries.\n\nThe Senior Manager serves as a central point of coordination across cross\u2011functional teams and external partners, ensuring rigorous execution, inspection readiness, and compliance with global regulatory and quality standards. The role collaborates closely with Medical Affairs, HEOR, Regulatory, Safety, Legal, QA, and external investigators, vendors, and CROs to deliver impactful evidence aligned with business and scientific objectives.\n\nKey Responsibilities\n\n * Lead operational planning, execution, and oversight of medical affairs research initiatives including Alnylam\u2011sponsored studies and collaborative research initiatives\n * Provide oversight and strategic direction to CROs and vendors, to ensure performance, quality, and budget adherence\n * Work, either directly with the CRO, or as part of the internal team to contribute to the development of program-specific plans and study documents, e.g. protocol, informed consent forms, training materials, CRFs, manuals. \n * Review and maintain study specific plans generated by CRO\n * Ensure inspection readiness and compliance with applicable ICH/GPP standards, internal SOPs, and global regulatory requirements\n * Partner closely with QA, GPSRM, Legal, and Compliance to support audits, inspections, and continuous process improvement\n * Provide organizational and project support by working directly with cross-functional individuals and teams to coordinate and execute activities related to key medical affairs studies\n * Coordinate development of agendas and maintain oversight of action items from program team (internal) and vendor meetings to drive execution of key initiatives and facilitate decision-making \n * Management of study budgets, including annual budget planning\n\n\n\nQualifications\n\n * BA/BS in life sciences or related field required; advanced degree preferred.\n * Proven experience in pharmaceutical/biotech industry, prior experience in Clinical Operations and/or Medical Affairs managing GCP/GPP studies.\n * Strong knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes\n * Experience managing CROs and vendors across multiple studies and geographies\n * Must be able to actively manage and track many complex projects in parallel, managing the actions of many people toward shared outcomes \n * Excellent communication skills and relationship building capabilities\n * Strong team player that has a customer service approach and is solution oriented\n * Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors \n * Clear alignment with Alnylam Core Values\n\n\n\n#LI-AB1 #LI-Hybrid\n\nU.S. Pay Range\n\n$144,500.00 - $195,500.00\n\nThe pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).\n\nAlnylam\u2019s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.\n\nLearn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers\n\nAbout Alnylam\n\nWe are the leader in RNAi therapeutics \u2013 a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what\u2019s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We\u0027re proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.\n\nAt Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.\n