Alnylam Pharmaceuticals

Lead and coordinate regulatory project management activities across global R&D product lifecycle, ensuring alignment, tracking submissions, facilitating meetings, and driving execution of submission strategies. | At least 6 years in regulatory affairs or project management in pharma/biotech, proficiency in project management tools, experience with global regulatory submissions, strong communication and organizational skills. | Lead regulatory-focused project management activities across the R&D product lifecycle, including global expansion. Develop and continuously optimize detailed regulatory project plans and timelines in close collaboration with the Global Regulatory Lead, Regulatory Operations, and sub-team leads. Identify and manage project interdependencies to ensure alignment across functions and understand critical path activities. Maintain real-time filing timelines and track key submissions/deliverables from investigational and marketing applications to registration. Interface with filing sub-teams to ensure mutual understanding and agreement on submission timelines and deliverables. Plan and facilitate cross-functional meetings/workshops (e.g., filing kick-off) to drive execution of submission strategies. Facilitate and co-lead critical filing team and sub-team meetings, ensuring follow-through on project deliverables and action items across the relevant expertise areas (e.g., nonclinical, CMC, clinical, regulatory functions). Ensure development of document reviewer/approver matrices and coordinate review cycles and roundtables aligned with submission timelines. Maintain comprehensive project dashboard(s) to communicate progress, risks, and key updates to teams and senior management. Proactively identify and escalate risks related to resources, timing, and deliverables as appropriate. Coordinate lessons learned sessions and facilitate implementation of feedback for process improvement Contribute to the development and refinement of best practices and standardized processes for key regulatory submissions. Bachelor's degree in life sciences, pharmacy, or related field preferred with at least 6 years' experience in regulatory affairs or project management within the pharmaceutical or biotech industry Demonstrated project management skills with strong ability to prioritize multiple projects. Formal project management training is a plus. Proficiency in project management tools (e.g., Smartsheet, MS Project) and content management systems. Experience with timeline visual tools (OnePager, Think-Cell, Office Timeline, or similar) is a plus. Experience managing global regulatory submissions for initial investigational and/or marketing applications, including response to health authority questions. Understanding of regulatory processes, requirements and experience in interpretation of Health Authority guidelines. Ability to work both independently and collaboratively within a matrixed, cross-functional environment, leveraging strong interpersonal skills to build effective partnerships across departments and levels. Excellent written and verbal communication skills, including negotiation skills. Excellent organizational and meeting management/facilitation skills. Ability to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion. Detail-oriented with a strong sense of accountability and urgency.

Lead global clinical investigator site quality oversight by monitoring quality indicators, managing risks, ensuring compliance, supporting audits and inspections, and driving process improvements across clinical trial sites. | 6-8+ years in clinical research or quality assurance with strong knowledge of GCP regulations, quality metrics, auditing, risk management, and experience collaborating across clinical operations and quality teams. | Overview The Clinical Site Quality Oversight Lead supports the execution of quality oversight activities designed to monitor and drive improvements in clinical investigator site quality performance across programs. This position works closely with colleagues responsible for study management; Clinical Operations; Data Sciences Statistics and Epidemiology (DSSE); Clinical Research; etc. Collectively referred to as the Clinical Development Organization (CDO). The Sr. Manager, Clinical Quality Site Oversight Lead will partner and support the Alnylam CDO to ensure quality and compliance is established and maintained across clinical trial sites globally. This role will also work in close collaboration with with program/study GCP Program Leads, the R&D Quality Process Improvement team, as well as the Quality Analytics and Insights team. This role is laser focused on cross-program, global, investigator site quality and compliance. Key Responsibilities • Develop robust investigator site quality oversight, including establishment of site Key Quality Indicators (KQIs), to enable global, high-quality clinical trial execution. • Monitor risk signal detection, signal management, action planning, and action verification with the Risk Based Quality Management Team for site-level risks across clinical programs. • Monitor investigator site performance KQIs across clinical programs and studies (e.g., global and regional trends) and ensure timely escalation and action of identified issues and trends. • Monitor Investigator Site File (ISF) KQIs, ensuring compliance and readiness. Partner with TMF team to drive corrective/preventive actions at the process level to ensure inspection readiness at all times. • Utilizing site performance KQIs, Risk Signals, TMF KQIs: • Proactively identify site-specific (cross-program) quality issues or trends, ensure timely escalation, and effectively resolve emerging risks, in collaboration with GCP Program Leads, who manage study-specific compliance issues and risks. • In collaboration with the GCP QA Leads, identifying critical aspects and helping to develop the integrated Data Quality Plans (iDQP). • Support Investigator Meeting material, SIV materials, CRA training materials, as requested, and provde training or support to investigator sites in addressing queries pertaining to Quality. • Partner with Quality Analytics and Insights to develop Alnylam-facing dashboards via data integration or data shuttling from clinical trial systems to support the quality oversight of items including but not limited to major and minor protocol deviations, open/aging monitoring issues, detections delays, and data entry timeliness. • Support site-facing template review and development and help facilitate associated process improvement initiatives to ensure robust quality practices are implemented globally. • Evaluate and risk assess regulatory intelligence communications to ensure implementation of local and regional GCP requirements (or equivalent) at a site level and from a process (cross-program) perspective in emerging markets/regions. • Support Investigator site audits, as requested, and trend on observations and risks for ongoing or upcoming audits. • Support site inspection preparation and management activities, as appropriate. For example, helping to identify key risks or data points and make recommendations on sites of interest. • Define and guide global strategy and governance for investigator site systems across studies. Oversee these site systems in alignment with ICH GCP E6(R3) requirements. Qualifications • Educated in life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent work experience including clinical research, regulatory or quality. • Minimum of 6-8 years of relevant experience • Experience in quality assurance, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GCP auditing. • Understanding of GCP regulations and guidance for FDA, MHRA, PMDA, and International agencies including ICH guidelines. • Experience with quality metrics, management of quality events (i.e. serious breach), assessment of GCP compliance, and the application of risk-based thinking. The 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: https://www.alnylam.com/careers About Alnylam We 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.

Develop and execute territory and account plans targeting healthcare providers to increase brand awareness and product adoption, manage relationships with physicians and internal stakeholders, and utilize resources to drive sales results. | Requires a 4-year degree, 1-3+ years biotech or specialty pharma sales experience, strong interpersonal and communication skills, basic data analysis ability, willingness to travel extensively, and valid driver's license. | Identify and/or target healthcare providers and accounts managing and treating patients with TTR amyloidosis to develop plans to increase brand awareness and product adoption. Continuously assesses sales opportunities and challenges within territory and accounts to maintain and grow their business. Effectively prioritizes and manages time, activities, and resources to optimize access to and development of accounts with the most sales potential. Builds and maintains relationships with physicians by maximizing their time through pre-call planning, leveraging insights to tailor a call plan, and conducting post-call analysis to continually refine and enhance their approach. Proactively builds effective working relationships with internal/external stakeholders; can drive agreement/decisions from multiple stakeholders; can read people's emotions and flex communication style. Adjusts their approach based on different stakeholder needs, concerns, or audience member to drive alignment and meet their work goals. Effectively communicates and closely collaborates with stakeholders across commercial, compliance, legal, market access, and patient care centers to help ensure access at site of care. Builds individual account plans for key accounts and physicians including how to approach those customers, achieve sales goals, and maximize sales results. Collaborates with key accounts and physicians to drive patient identification through market development and physician education; develop a territory strategy to retain customers. Effectively utilizes resources such as programs, in-services, and in office presentations to impact territory results. Demonstrates and upholds the highest standards of integrity and compliance. Additional responsibilities as required to support business needs and organizational priorities. 4-year degree from an accredited college or university required. B2B sales experience required. 1-3 years+ of progressive and successful business experience in biotech or the specialty pharmaceutical industry. Strong interpersonal skills with the ability to build relationships and rapport with internal teams and stakeholders. Basic understanding of data analysis tools and ability to interpret simple datasets. Willingness to learn and adapt to changing environments and new methodologies under supervision. A growth mindset with the ability to treat challenges as learning opportunities. Demonstrates adherence to all company policies, industry regulations, and ethical standards, ensuring compliant business practices at all times. Excellent communication and listening skills. Collaboration: Builds foundational relationships, seeks feedback, and adapts to new methods with guidance. Customer Focus: Engages customers with empathy, delivers approved messaging based on customer needs, and starts building trust with stakeholders. Execution: Completes tasks on time, tracks performance, and begins aligning business plans with team goals and emerging trends in their territory. Critical Thinking: Learns basic data analysis, identifies opportunities, and makes small decisions with support. Must be comfortable spending 60% of time traveling; some overnight travel required including travel to Boston, congresses and within large geographical territories. Driving is an essential duty of the job; candidates must have a valid driver's license to be considered and be insurable. Must live within assigned territory.