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Alnylam Pharmaceuticals
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  • Overview Alnylam Pharmaceuticals is seeking an imaginative physician d... Read More
    Overview Alnylam Pharmaceuticals is seeking an imaginative physician drug developer. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology.The successful candidate’s primary role will be to drive the pipeline forward through leadership of clinical development programs.  While the primary focus responsibility will be as clinical lead physician on Alnylam’s Huntington’s program, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve. The Sr. Director is expected to play a leading and influencing role in the overall clinical development strategies and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam’s research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs.The Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies. They will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.This position is hybrid and will be primarily located at our Cambridge, MA headquarters or Maidenhead, UK location.Key ResponsibilitiesBe the strategic leader providing a strong, clear voice for the clinical programsDevelop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvalsOversight of trial conduct and safety Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications. Collaborate closely with Preclinical, Regulatory Affairs, Medical Affairs and Commercial to ensure tight strategic integration of product development plansBe accountable via Clinical Research and Operations for all relevant timelines and deliverablesDrive/supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materialsBe responsible (as appropriate in line with SOPs) for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent formsInfluence internal and external audiences in a high impact, highly visible fashionQualificationsMD with strong research background or MD PhD, with a track record of successful research support and peer review publications. Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in neurology (Huntington’s Disease) would be a great advantage, but not essential10+ years industry experience or equivalent clinical academic experienceSound scientific and clinical judgmentSuccessful track record of leading Phase 2/3 clinical programs (preferably in Huntington’s drug development), including major interactions with Health Authorities Familiarity with concepts of clinical research and clinical trial design, including biostatistics, regulatory agency organization, guidelines, and practicesAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationHistory of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issuesOutstanding leadership and collaboration skills working within a matrix environment.Experience and knowledge of working with biotech/pharma partner(s) a plusThrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency.U.S. Pay Range$305,700.00 - $413,700.00The 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).Alnylam’s 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.Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: About AlnylamWe are the leader in RNAi therapeutics – 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’s 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're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.At 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.This role is considered::HybridDepartment:Clinical Research Read Less
  • The Associate Director of Regulatory Affairs Strategy will work on ass... Read More
    The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead the regulatory strategy and facilitate submission of data packages to the EMA. The role is expected to serve as an EU Regional Lead for our mid/late-stage CNS programs and may have the opportunity to be the Regulatory Program Lead for early programs in Alnylam pipeline. The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role will represent RA on multidisciplinary product development subteams and Global Regulatory Team. Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory requirements, and interpreting regulatory intelligence for the internal teams.This is a hybrid position and will require regular prescence in our Maidenhead offices.Summary of Key ResponsibilitiesServe as EU Regional Lead for assigned program, or as Regulatory Program Lead, leading the Global Regulatory Team, for one of the early programs in the Alnylam pipeline.Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead EU HA interactions. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs), Marketing Applications, Paediatric Plans, Orphan Designation and Expedited Pathway Applications (e.g. PRIME), and any amendments.Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.Maintain regulatory files in a format consistent with internal requirements.Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.Provide EU specific regulatory intelligence to internal stakeholders as appropriate.QualificationsBachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 8 years’ experience working in the biotech or pharmaceutical industry. Higher degree would be a plus.Excellent written and verbal communication skills, including negotiation and influencing skills.Solid understanding of regulations and experience in interpretation of guidelines.Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.Experience with regulatory filings, including electronic submissions, e.g., CTAs, post-marketing variations, safety reporting, paediatric plans, PRIME etc.MAA filing and Type II variation experience is preferred.Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.Clear alignment with Alnylam Core Values including:Commitment to People,Fiercely Innovative,Purposeful Urgency,Open Culture, andPassion for Excellence.This role is considered::HybridDepartment:Regulatory Read Less
  • Senior Manager- Regulatory Strategy, EUOverviewThe Senior Manager of R... Read More
    Senior Manager- Regulatory Strategy, EUOverviewThe Senior Manager of Regulatory Affairs will report to the Director, Regulatory Affairs (RA) and will work with Global/EU regulatory lead, the program Leadership Team and other cross-functional teams to facilitate submission of applications to EU and International health agencies (HA) for Alnylam’s RNAi therapeutics.  The role will work across programs to support the development of Alnylam’s products globally.  In doing so they are responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role will contribute to regulatory strategy and may represent the department on multidisciplinary product development subteams.  Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory requirements and internationally as relevant, and distributing regulatory intelligence to internal teams.Summary of Key ResponsibilitiesWork with Global/EU regulatory lead to define regulatory strategy and to lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex regulatory submissions throughout the product's life cycle.  This may include relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs, INDs) and substantial modifications etc, Paediatric Plans, Orphan Designation, Expedited Pathway Applications (e.g. PRIME), and Marketing Applications and any amendments.Develop detailed regulatory strategy and project plans and support regulatory activities relating to specific portfolio of products/projects.Serve as member of the Global Regulatory Team, serve as Regulatory representative in multidisciplinary product subteams for assigned programs and participate as an active team member and provide strategic regulatory advice.Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.Maintain regulatory files in a format consistent with internal requirements.Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.Provide EU specific regulatory intelligence to internal stakeholders as appropriate.QualificationsBachelor's degree with 4 or more years of experience in a Regulatory Affairs strategy role working in the biotech or pharmaceutical industry. Advanced scientific degree preferred.Excellent written and verbal communication skills, including negotiation and influencing skills.Solid understanding of regulations and experience in interpretation of guidelines.Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.Experience with regulatory filings, including electronic submissions, e.g., CTAs, DSURs, post-marketing variations, paediatric plans, ODD etc.Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.Clear alignment with Alnylam Core Values including:Commitment to People,Fiercely Innovative,Purposeful Urgency,Open Culture, andPassion for Excellence.This role is considered::HybridDepartment:Regulatory Read Less
  • OverviewThe Associate Director, Clinical Pharmacology supports a rapid... Read More
    OverviewThe Associate Director, Clinical Pharmacology supports a rapidly expanding clinical portfolio of RNAi therapeutics within the CNS franchise. This role provides clinical pharmacology expertise across clinical-stage programs, with a strong focus on pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD analyses to inform clinical development and regulatory decision-making.The position requires strong scientific expertise, critical thinking, and the ability to independently interpret and integrate complex clinical pharmacology data within a highly matrixed environment. The Associate Director partners closely with Research, Clinical Development, Bioanalytical, Regulatory, Project Management, and other R&D functions, contributing to clinical study design, data analysis, regulatory submissions, and scientific publications in support of advancing innovative RNAi therapies.This is a virtual role based in The Netherlands or UK. Key ResponsibilitiesRepresent independently Clinical Pharmacology and provide clinical pharmacology support and guidance to clinical stage project teams.Lead the analysis, interpretation, integration and reporting of clinical pharmacology dataConduct PK and PK/PD analyses to guide clinical development decisionsProvide clinical pharmacology input for regulatory submissions such as briefing documents, IND, CTA and NDAPrepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or dataClosely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functionsPreparation of abstracts and manuscripts for publicationsQualificationsPh.D. ( or Pharm.D.) in relevant field (i.e. Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with in depth experience in pharmaceutical/biotech industryIn depth knowledge of clinical pharmacology, pharmacokinetics, modeling and simulation, PK/PD principles, ADME and clinical data interpretationIn depth knowledge of international guidelines related to Clinical Pharmacology and PharmacometricsProficient in using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.Ability to function in a highly matrixed team environment is essentialAbility to work independentlyStrong communication and presentation skills (verbal and written)Excellent interpersonal skills and ability to work independentlyFluency in English (verbal and written)Why Alnylam?Join a company recognized for its innovation, open culture, and commitment to people. At Alnylam, you’ll work in an environment that values collaboration, purpose, and excellence — and be part of a team bringing groundbreaking RNAi therapies to patients in need.Apply now to make a difference where science meets purpose.This role is considered::VirtualDepartment:Clinical Development Read Less
  • OverviewThe Associate Director, Brand Marketing will sit within the In... Read More
    OverviewThe Associate Director, Brand Marketing will sit within the International Marketing, Rare Diseases team, part of the Global Rare Business Unit (GRBU). This team is responsible for driving the commercialization and overall product management of GIVLAARI and OXLUMO within the International Clusters.This role will partner with local commercial teams and with key EAs across the International Central and West Clusters (Medical Affairs, Patient Advocacy, Product Communications and others) to understand market dynamics, provide strategic direction and execute impactful initiatives to improve patients lives and to help the GRBU to achieve their commercial goals.This role will report to the Director, International Rare Marketing.Key ResponsibilitiesThe exact responsibilities will be defined based on each programme (AHP and PH1) specific business needs. Overall, the role includes the following areas of responsibilities:Understand market and competititve dynamics in the Central and West International cluster markets and generate insights to input global brand planning  Drive International Brand Strategy, Tactical Planning and prioritization for AHP/PH1 ensuring strong alignment between global brand imperatives, local market needs and cross-functional execution.Provide strategic direction and support local teams in their commercialization efforts, while ensuring the consistent execution towards global brand imperatives and goalsDevelop and execute, in coordication with local teams, a tactical plan with impactful initiatives across patients and HCPs to improve AHP and PH1 patients’ lives and brand performanceOwn the tactical marketing budgeting process for the assigned rare disease brand, including annual planning, resource allocation, budget tracking and optimization of investments to ensure high-impact execution in line with brand priorities and on-budget delivery.Contribute to the transfer of best practices among different parts of the GRBU organization ensuring assessment of signature initiatives effectiveness, amplification of successful tactics and systematic removal of tactics with lesser impact.Innovate and encourage innovation in ways to commercialize Rare Diseases in a most efficient ways leveraging digital and data-driven approaches.Follow up execution of tactical plan to deliver initiatives on time and on budget.Foster external scientific engagement with KOL’s, stakeholders and scientific societies to drive collaboration and knowledge exchangeLead the planning and execution of international congress activities for the assigned rare disease brand, ensuring strategic scientific and commercial presence, cross-functional coordination, and alignment with brand objectives and external engagement priorities.QualificationsMBA or equivalent with a preference for a science degree Min. 8+ years of industry experience in Pharmaceutical or BioTech space.Significant product leadership experience, proven by delivery of biopharmaceutical commercial experience.Experience in orphan drugs commercialization and development of local solutions to optimize value is preferredOutstanding understanding of specialty care commercialization in Europe, particularly in the rare disease space, including Market Access key success factors.Demonstrated business and financial acumenProven track record of successfully leading projects or initiatives in complex multi-regional environmentsDemonstrated strategic thinking with the ability to analyize complex situations, anticipate challenges and develop innovative solutions that aligns with objectivesStrong network/matrix stakeholder communications skills with both global, regional and in-country teams.Continued external focus, testing all plans against market and customer insights.Motivational leader with the ability to inspire and energize cross-functional and cross-country teams to drive collaboration and achieve shared objectivesOrganizational flexibility and outstanding listening skills; comfortable and track record of operating and influencing in all directions in a global network/matrix environmentThis role is considered::HybridDepartment:Marketing Read Less
  • The Associate Director Study Management (AD Clinical Operations) is re... Read More
    The Associate Director Study Management (AD Clinical Operations) is responsible for leading a team of Global Trial Leaders and Trial Managers within the Study Management Organization.  The position is responsible for staff development and study oversight, and will work closely with the Director for input on project assignments, workload distribution, resourcing, and prioritization.  The Associate Director directly influences trial objectives and ensures common operational issues/challenges are identified within and potentially across trials and programs and are addressed through operational risk mitigation, including proposals for alternative solutions.  The Associate Director is accountable for the operational execution and delivery of assigned trials within a program, ensuring alignment across study teams and functions.This is a hybrid role based in Maidenhead. However, for exceptional candidates, remote working arrangements may also be considered.Summary of Key ResponsibilitiesAccountable for the delivery of the operational strategy in alignment with the Clinical Development Plan, ensuring alignment with the business goals and trial delivery objectives (including resourcing, budget, and change control) by partnering with CTWG and CDST on timeline creation. May Chair and/or support the Trial Leader in leading the CTWGfor the successful execution of assigned trial/s.Develop and execute trial operational strategies for assigned studies and contribute to broader program-level planning in partnership with the Director and cross-functional stakeholders.Lead operational scenario planning and mitigate trial level risks that may impact timelines / budget.Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership.Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CTWG, CDST, Director, leadership and at governance meetings as appropriate.Lead and ensure inspection readiness for the trial/sBuild knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trialsPromote strong collaboration across cross-functional teamsSetting goals in alignment with company, program, and departmental goalsEnsure staff training on procedures and systems associated with their rolesDevelop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidanceFor early development programs, AD may represent Clinical Operations at CDSTInterface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.Lead or participate in process improvement activities at a trial and department level as neededParticipate in preparation for, and conduct of, Health Authority Inspections and internal QA auditsAbility to travel (expected annual average of 10% but flexibility to go over or below this as required).QualificationsBS/ BA degree is required.Minimum 8+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials, at least 3 of which leading end to end global clinical trials with experience in conducting Phase 3 registrational trials.Minimum 2-5 years of direct people leadership experience, including coaching, performance management, and development of clinical operations professionals.Experience in and knowledge of the pharmaceutical development processExcellent decision-making, analytical and strong financial management skills are essential to this positionAbility to manage all aspects of execution of a clinical trialMust possess excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervisionExperience in leading without authority and in multifunctional matrixed and global environmentsStrong project planning/ management, communication (written and verbal) and presentation skillsExceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.Apply project management best practices to programs. Experience in novel clinical drug development.Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.#LI-RemoteThis role is considered::HybridDepartment:Clinical Operations Read Less
  • OverviewThe Associate Director, Brand Marketing will sit within the In... Read More
    OverviewThe Associate Director, Brand Marketing will sit within the International Marketing, Rare Diseases team, part of the Global Rare Business Unit (GRBU). This team is responsible for driving the commercialization and overall product management of GIVLAARI and OXLUMO within the International Clusters.This role will partner with local commercial teams and with key EAs across the International Central and West Clusters (Medical Affairs, Patient Advocacy, Product Communications and others) to understand market dynamics, provide strategic direction and execute impactful initiatives to improve patients lives and to help the GRBU to achieve their commercial goals.This role will report to the Director, International Rare Marketing.Key ResponsibilitiesThe exact responsibilities will be defined based on each programme (AHP and PH1) specific business needs. Overall, the role includes the following areas of responsibilities:Understand market and competititve dynamics in the Central and West International cluster markets and generate insights to input global brand planning  Drive International Brand Strategy, Tactical Planning and prioritization for AHP/PH1 ensuring strong alignment between global brand imperatives, local market needs and cross-functional execution.Provide strategic direction and support local teams in their commercialization efforts, while ensuring the consistent execution towards global brand imperatives and goalsDevelop and execute, in coordication with local teams, a tactical plan with impactful initiatives across patients and HCPs to improve AHP and PH1 patients’ lives and brand performanceOwn the tactical marketing budgeting process for the assigned rare disease brand, including annual planning, resource allocation, budget tracking and optimization of investments to ensure high-impact execution in line with brand priorities and on-budget delivery.Contribute to the transfer of best practices among different parts of the GRBU organization ensuring assessment of signature initiatives effectiveness, amplification of successful tactics and systematic removal of tactics with lesser impact.Innovate and encourage innovation in ways to commercialize Rare Diseases in a most efficient ways leveraging digital and data-driven approaches.Follow up execution of tactical plan to deliver initiatives on time and on budget.Foster external scientific engagement with KOL’s, stakeholders and scientific societies to drive collaboration and knowledge exchangeLead the planning and execution of international congress activities for the assigned rare disease brand, ensuring strategic scientific and commercial presence, cross-functional coordination, and alignment with brand objectives and external engagement priorities.QualificationsMBA or equivalent with a preference for a science degree Min. 8+ years of industry experience in Pharmaceutical or BioTech space.Significant product leadership experience, proven by delivery of biopharmaceutical commercial experience.Experience in orphan drugs commercialization and development of local solutions to optimize value is preferredOutstanding understanding of specialty care commercialization in Europe, particularly in the rare disease space, including Market Access key success factors.Demonstrated business and financial acumenProven track record of successfully leading projects or initiatives in complex multi-regional environmentsDemonstrated strategic thinking with the ability to analyize complex situations, anticipate challenges and develop innovative solutions that aligns with objectivesStrong network/matrix stakeholder communications skills with both global, regional and in-country teams.Continued external focus, testing all plans against market and customer insights.Motivational leader with the ability to inspire and energize cross-functional and cross-country teams to drive collaboration and achieve shared objectivesOrganizational flexibility and outstanding listening skills; comfortable and track record of operating and influencing in all directions in a global network/matrix environmentThis role is considered::HybridDepartment:Marketing Read Less
  • Senior Manager- Regulatory Strategy, EUOverviewThe Senior Manager of R... Read More
    Senior Manager- Regulatory Strategy, EUOverviewThe Senior Manager of Regulatory Affairs will report to the Director, Regulatory Affairs (RA) and will work with Global/EU regulatory lead, the program Leadership Team and other cross-functional teams to facilitate submission of applications to EU and International health agencies (HA) for Alnylam’s RNAi therapeutics.  The role will work across programs to support the development of Alnylam’s products globally.  In doing so they are responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role will contribute to regulatory strategy and may represent the department on multidisciplinary product development subteams.  Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory requirements and internationally as relevant, and distributing regulatory intelligence to internal teams.Summary of Key ResponsibilitiesWork with Global/EU regulatory lead to define regulatory strategy and to lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex regulatory submissions throughout the product's life cycle.  This may include relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs, INDs) and substantial modifications etc, Paediatric Plans, Orphan Designation, Expedited Pathway Applications (e.g. PRIME), and Marketing Applications and any amendments.Develop detailed regulatory strategy and project plans and support regulatory activities relating to specific portfolio of products/projects.Serve as member of the Global Regulatory Team, serve as Regulatory representative in multidisciplinary product subteams for assigned programs and participate as an active team member and provide strategic regulatory advice.Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.Maintain regulatory files in a format consistent with internal requirements.Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.Provide EU specific regulatory intelligence to internal stakeholders as appropriate.QualificationsBachelor's degree with 4 or more years of experience in a Regulatory Affairs strategy role working in the biotech or pharmaceutical industry. Advanced scientific degree preferred.Excellent written and verbal communication skills, including negotiation and influencing skills.Solid understanding of regulations and experience in interpretation of guidelines.Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.Experience with regulatory filings, including electronic submissions, e.g., CTAs, DSURs, post-marketing variations, paediatric plans, ODD etc.Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.Clear alignment with Alnylam Core Values including:Commitment to People,Fiercely Innovative,Purposeful Urgency,Open Culture, andPassion for Excellence.This role is considered::HybridDepartment:Regulatory Read Less
  • The Global Study Lead (Sr. Manager, Clinical Operations) is responsibl... Read More
    The Global Study Lead (Sr. Manager, Clinical Operations) is responsible for leading the operational planning and execution of global clinical trials from study start-up through closeout. This role provides leadership to cross-functional trial teams, ensuring trial objectives are achieved on time, within budget, and in compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures. The Sr. Manager identifies and mitigates operational risks, drives alignment across stakeholders, and delivers high-quality trial execution in support of development program goals.This is a hybrid role based in Maidenhead. However, for exceptional candidates, remote working arrangements may also be considered.Summary of Key ResponsibilitiesLead cross-functional trial teams to develop and execute study operational plans and deliver successful end-to-end trial execution.Accountable for trial-level delivery, including timelines, budget management, quality oversight, key milestones, and critical study deliverables.Oversee CRO and vendor selection, onboarding, contracting, budget management, performance monitoring, and issue resolution to ensure successful study delivery.Proactively identify operations risks and ensure that trial deliverables and milestones are met according to corporate and study-level goals.Identify risks and ensure mitigations and contingencies are being initiated and followed through.Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.Participate in preparation for, and conduct of, Health Authority Inspections and internal QA auditsEnsure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversightContribute to continuous improvement initiatives by identifying opportunities to enhance study execution, operational efficiency, quality, and cross-functional collaboration.Mentor and support onboarding and development of Study Management colleagues, sharing best practices and lessons learned across teams.Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.Prepare and provide operational updates, risks, and recommendations to governance forums, leadership teams, and cross-functional stakeholders.Ability to travel approximately 10% but flexibility to go over or below as per business need).QualificationsBS/ BA degree is required.Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials. 3-5 years leading end to end global clinical trials with experience in conducting Phase 3 registrational trialsExperience leading global trials outsourced to a CRO and ability to manage all aspects of execution of a clinical trialExcellent decision-making, analytical and financial management skills are essential to this positionExcellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervisionDemonstrated success leading cross-functional teams in global matrix organizations and achieving results through influence.Experience mentoring/ coaching othersExceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.Strong project planning/ management, communication (written and verbal) and presentation skillsProficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.#LI-RemoteThis role is considered::HybridDepartment:Clinical Operations Read Less
  • OverviewThe Associate Director, Clinical Pharmacology supports a rapid... Read More
    OverviewThe Associate Director, Clinical Pharmacology supports a rapidly expanding clinical portfolio of RNAi therapeutics within the CNS franchise. This role provides clinical pharmacology expertise across clinical-stage programs, with a strong focus on pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD analyses to inform clinical development and regulatory decision-making.The position requires strong scientific expertise, critical thinking, and the ability to independently interpret and integrate complex clinical pharmacology data within a highly matrixed environment. The Associate Director partners closely with Research, Clinical Development, Bioanalytical, Regulatory, Project Management, and other R&D functions, contributing to clinical study design, data analysis, regulatory submissions, and scientific publications in support of advancing innovative RNAi therapies.This is a virtual role based in The Netherlands or UK. Key ResponsibilitiesRepresent independently Clinical Pharmacology and provide clinical pharmacology support and guidance to clinical stage project teams.Lead the analysis, interpretation, integration and reporting of clinical pharmacology dataConduct PK and PK/PD analyses to guide clinical development decisionsProvide clinical pharmacology input for regulatory submissions such as briefing documents, IND, CTA and NDAPrepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or dataClosely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functionsPreparation of abstracts and manuscripts for publicationsQualificationsPh.D. ( or Pharm.D.) in relevant field (i.e. Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with in depth experience in pharmaceutical/biotech industryIn depth knowledge of clinical pharmacology, pharmacokinetics, modeling and simulation, PK/PD principles, ADME and clinical data interpretationIn depth knowledge of international guidelines related to Clinical Pharmacology and PharmacometricsProficient in using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.Ability to function in a highly matrixed team environment is essentialAbility to work independentlyStrong communication and presentation skills (verbal and written)Excellent interpersonal skills and ability to work independentlyFluency in English (verbal and written)Why Alnylam?Join a company recognized for its innovation, open culture, and commitment to people. At Alnylam, you’ll work in an environment that values collaboration, purpose, and excellence — and be part of a team bringing groundbreaking RNAi therapies to patients in need.Apply now to make a difference where science meets purpose.This role is considered::VirtualDepartment:Clinical Development Read Less

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