Associate Director of Regulatory Affairs

Join eGenesis as a Senior Clinical Research AssociateAt eGenesis, we are at the forefront of innovation in biotechnology, developing human-compatible engineered organs to combat the critical global organ shortage. Our cutting-edge genome engineering platform allows for extensive gene modifications, effectively removing biological barriers and introducing protective human transgenes. Our leading program, EGEN-2784, involves a genetically engineered porcine kidney currently under a multi-patient Expanded Access study at Massachusetts General Hospital (MGH). We are proudly headquartered in Cambridge, MA, and are dedicated to making a significant impact on healthcare.We are currently in search of a highly skilled Senior Clinical Research Associate with over 4 years of experience in monitoring intricate clinical trials within pharmaceutical, biotechnology, and CRO settings. The ideal candidate will demonstrate proven expertise in managing investigative sites, conducting site qualifications, initiation, routine monitoring (both on-site and remote), and closeout visits while ensuring adherence to ICH-GCP, regulatory requirements, and study protocols. You will be tasked with overseeing site performance, preserving data integrity through source data verification and CRF review, and maintaining timely documentation in eTMF, CTMS, and EDC systems. Additionally, you will support site start-up activities, provide training for investigators and site staff, and offer operational guidance to academic medical centers, particularly those with limited IND experience. The right candidate will possess strong capabilities in identifying operational risks, implementing effective mitigation strategies, and managing high volumes of clinical data to uphold patient safety, data quality, and study compliance. Reporting to the Lead CRA or Clinical Operations leadership, you will execute monitoring strategies and facilitate consistent oversight of assigned sites. We value collaboration and are looking for a team player who can work closely with investigative sites and cross-functional teams to enhance enrollment, address operational challenges, and ensure inspection readiness.

Join Scismic, a trailblazing biotech startup in Cambridge, MA, dedicated to developing groundbreaking mRNA-modulating therapies aimed at curing a wide array of genetic disorders. Our innovative platforms are being applied to address critical challenges in neurological diseases, heart conditions, and muscular dystrophies.Position Overview: We are seeking a Research Associate (RA-I or RA-II) who possesses a creative approach, meticulous attention to detail, and a collaborative spirit to help propel our therapeutic candidates towards clinical application. This is a unique opportunity to make a significant impact on the lives of patients with serious unmet medical needs while working alongside our esteemed scientific team, including our visionary scientific co-founders. In this role, you will work closely with the in vivo pharmacology team to evaluate the effects of therapeutic lead candidates. The Research Associate will engage with animal models for rare genetic diseases, executing experiments that quantify molecular, cellular, and physiological outcomes, as well as supporting in vivo dosing studies and additional research activities within the in vivo pharmacology team. This position is ideal for a driven scientist eager to advance their knowledge in neuroscience, physiology, and gene therapy, all while contributing to the welfare of patients affected by rare diseases.

Serif Biomedicines, Inc., based in Cambridge, MA, is a privately-held biotechnology company developing gene therapy approaches for diseases without current effective treatments. Founded by Flagship Pioneering, the company is part of a network that includes organizations such as Moderna, Syros Pharmaceuticals, and Evelo Biosciences. Role overview This Research Associate position centers on cell biology research, with a focus on understanding how nucleic acids function within cells. The role is laboratory-based and involves close collaboration with a multidisciplinary team. What you will do Culture and maintain a range of cell lines, including immune and non-immune cells. Design, perform, and refine assays to study nucleic acid function in primary cells and established cell lines in vitro. Communicate experimental plans and results through presentations and written reports, maintaining thorough electronic lab records. Work both independently and as part of a diverse research team.

Join Engine as a Senior Associate in Community OperationsAt Engine, we empower visionary founders who are tackling the world's most critical challenges in areas such as climate change, health, and advanced technologies. Our commitment includes providing robust support through founder programs, access to shared infrastructure and labs, and the opportunity to connect with a diverse national network of corporate partners, investors, and industry experts.

Iterative Health is at the forefront of healthcare technology and services, dedicated to accelerating clinical research that significantly transforms patient outcomes. With our unique Iterative Health Site Network comprising over 70 premier clinical research sites across the US and Europe, we expedite the market introduction of innovative gastrointestinal (GI) and hepatology therapies. Our mission centers on empowering our partner sites with tech-enabled services that foster their growth and success. By integrating deep clinical trial expertise with advanced AI capabilities, we enable research teams and study sponsors to broaden and accelerate access to novel therapeutics for patients in need.We are in search of a dynamic and detail-oriented Payroll Specialist to join our team in a full-time capacity. The ideal candidate is an enthusiastic self-starter driven to set and achieve goals while taking initiative in their role. This professional will play a crucial role in minimizing manual processing risks, ensuring compliance with regulations, automating systems, and overseeing day-to-day payroll operations. This position offers an excellent opportunity to enhance your payroll and accounting expertise while contributing to the accuracy and efficiency of our financial operations and supporting broader financial reporting and compliance efforts.

Scholar Rock is a pioneering biopharmaceutical enterprise dedicated to the discovery, development, and delivery of transformative therapies for individuals with serious diseases that are significantly underserved. Renowned for its leadership in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, Scholar Rock is committed to advancing innovative treatments where protein growth factors are essential. Over the last decade, the company has established a robust pipeline aimed at enhancing the standard of care for various conditions including neuromuscular diseases, cardiometabolic disorders, and cancer, where growth factor-targeted therapies can make a monumental difference. Scholar Rock stands out as the only organization to demonstrate clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our dedication to exploring fundamentally novel therapeutic strategies is driven by the application of a proprietary platform that has yielded innovative monoclonal antibodies designed to modulate protein growth factors with remarkable selectivity. By leveraging advanced scientific approaches in historically neglected disease areas, Scholar Rock is committed to unlocking new opportunities for patients. Discover more about our mission at ScholarRock.com and connect with us on @ScholarRock and LinkedIn.Position Overview:The Medical Director, reporting to the VP of Clinical Research, will play a vital role in the early development team, responsible for steering clinical development initiatives for product candidates from IND to Proof-of-Concept. This role demands a highly driven physician scientist with hands-on experience in advancing product candidates aimed at delivering impactful medicines. The successful candidate will provide medical leadership for clinical development activities related to follow-on indications for apitegromab and new product candidates, aligning with corporate strategy.

COMPANY DESCRIPTION We are a pioneering start-up dedicated to transforming the landscape of chemical discovery. Our innovative platform integrates artificial intelligence with a state-of-the-art laboratory discovery pipeline to redefine molecular formulation development. Our interdisciplinary team is exploring uncharted chemical territories, facilitating significant advancements in drug delivery, agricultural formulations, and sustainable, high-performance industrial chemicals. Backed by Flagship Pioneering, a leader in biotechnology origination, we have fostered over 115 scientific ventures in 25 years, generating more than $20 billion in aggregate value, 500+ patents, and over 50 clinical trials for groundbreaking therapeutic agents. THE ROLE We are on the lookout for a passionate and skilled Senior Research Associate or Associate Scientist to enhance our formulation discovery platform by characterizing biomolecules. This position involves utilizing a range of biophysical and biochemical methodologies to analyze the effects of formulations on biomolecular integrity, aggregation, and functional stability. You will collaborate closely with chemists and machine-learning experts to produce high-quality experimental data that drives formulation design and predictive modeling initiatives. The ideal candidate will possess a solid background in biochemistry, structural biology, or biopolymer engineering, complemented by practical experience with analytical instrumentation for biomolecular characterization. KEY RESPONSIBILITIES Conduct experiments assessing biomolecular stability and solubility across various formulation conditions. Evaluate cargo structural integrity and folding utilizing circular dichroism (CD) spectroscopy and complementary biophysical techniques. Measure biomolecular interactions and stability through spectroscopy, dynamic light scattering, and electrophoretic methods. Prepare samples for diverse external workflows to evaluate molecular integrity and degradation. Experimental Pipeline Support Collaborate with formulation chemists to investigate cargo-formulation interactions across different experimental contexts. Generate high-quality experimental datasets to assist internal modeling and data analysis processes. Support laboratory instrumentation maintenance and troubleshooting. Maintain organized laboratory records, analyze results, and communicate findings effectively to cross-functional teams.

Fathem develops tools that help scientists visualize and interpret biology at the molecular level. The company integrates cryo-electron microscopy (cryo-EM), artificial intelligence, advanced hardware, and automation to make molecular structures more accessible and speed up drug discovery. As part of Flagship Pioneering, Fathem draws on substantial resources to reshape how biology is explored and applied. Role overview The Senior Research Associate - Cryo-EM will play a key part in refining and executing cryo-EM workflows. This hands-on position focuses on preparing high-quality cryo-EM grids and datasets from a variety of biomolecular samples, including soluble proteins, membrane proteins, and nanoparticles. The role requires close collaboration with protein biochemistry, structural biology, and computational teams to ensure reliable grid preparation and imaging processes that feed into advanced computational modeling. Success in this position means solving complex biochemical challenges and seeing direct impact on scientific outcomes. What you will do Prepare cryo-EM grids and collect data from diverse biomolecular systems, maintaining efficiency and high standards for dataset quality. Carry out the full cryo-EM process, including grid vitrification, screening, and high-throughput data acquisition using Thermo Fisher microscopes. Operate and improve workflows to ensure reproducible, scalable data generation and increase throughput and reliability. Adjust and optimize protocols for challenging samples, refining grid preparation and imaging methods to boost success rates. Run experiments for external partners and clients, ensuring datasets align with project requirements. Work closely with protein science and computational teams to integrate cryo-EM data into broader research projects. Location This position is based in Cambridge, MA, USA.

THE ROLE As an Associate or Senior Associate within Molly Gibson’s Pioneering Business Unit (PBU) at Flagship Pioneering, you will engage in the ideation, research, and refinement of innovative venture hypotheses. Your primary responsibilities will include validating critical biological and technological unknowns and transforming rigorously tested concepts into a NewCo centered on scientific advancements. You will play a pivotal role in the origination of the company, encompassing the early stages of identifying and recruiting essential partners and advisors, establishing foundational intellectual property, leading the recruitment of the initial scientific team, and fostering a productive team culture. In this position, you will collaborate with stakeholders across the expansive Flagship ecosystem to leverage comprehensive support for your ventures. A successful candidate will become the authority on the foundational science of the enterprise, articulate and frame the strategic direction, and translate this strategy into actionable plans, operationalizing them alongside a Principal or Partner from the venture creation team.

Your Contribution at Lila Sciences Lila Sciences is actively seeking a dedicated (Senior) Research Associate to become an integral part of our dynamic Life Sciences team. This pivotal role will be centered around the formulation of lipid nanoparticles (LNPs), their functionalization with targeting ligands, and the characterization of the resulting targeted LNPs (tLNPs). The ideal candidate will possess substantial hands-on experience in LNP formulation and characterization, bioconjugation, protein characterization, and automation technologies. Your expertise will significantly enhance our understanding of the delivery space, enabling a high-throughput closed-loop screening cascade for tLNPs. You will work collaboratively with professionals across protein, cell biology, automation, chemistry, machine learning, and data science teams to establish advanced tools for targeted nucleic acid delivery. Your Key Responsibilities Design, execute, and characterize LNP formulations utilizing various scales and mixing modalities (e.g., DLS, ribogreen, TNS). Develop and optimize high-throughput ligand conjugation and purification methodologies, leveraging automation and robotics to maximize throughput. Collaborate with cell assay and antibody experts to screen candidates across diverse tissue targets in in vivo models. Engage with chemists, biologists, engineers, and data scientists to document processes, share insights, and refine best practices in autonomous flow chemistry. Create, implement, and uphold Standard Operating Procedures (SOPs) for both existing and emerging lab processes. Your Qualifications for Success MSc in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a closely related field with 3+ years of hands-on experience in targeted LNP production or a BSc with 5+ years of relevant experience. Industry experience is highly desirable. Strong proficiency in bioanalytical techniques (e.g., DLS, fluorescence spectroscopy, electrophoresis, in vitro assays). Experience in protein and antibody design and characterization. Familiarity with automation and high-throughput workflows is preferred. Exceptional troubleshooting, communication, and collaboration skills, with a proven ability to work effectively across interdisciplinary teams. About Lila Sciences Lila Sciences is at the forefront of innovation as the world's first scientific superintelligence platform and autonomous laboratory focused on life sciences, chemistry, and materials science. We are pioneering a new era of limitless discovery by harnessing AI capabilities to enhance every facet of the scientific method. Our mission is to leverage scientific superintelligence to address humanity's most pressing challenges.

We are seeking a highly motivated Senior Research Associate to join our dynamic team at Integrated Resources, Inc. In this pivotal role, you will conduct advanced research, analyze data, and contribute to innovative projects that drive our mission forward. If you are passionate about scientific research and eager to make an impact, we want to hear from you!

We are seeking a talented and dedicated Senior Research Associate to join our dynamic team in Cambridge. In this role, you will contribute to innovative research projects and collaborate with interdisciplinary teams to drive impactful findings.

About the Cambridge Boston Alignment InitiativeThe Cambridge Boston Alignment Initiative (CBAI) is a pioneering nonprofit research organization committed to fostering research and education aimed at ensuring a safe and beneficial transition to advanced artificial intelligence systems. Our initiatives encompass producing original research and propelling AI safety research through innovative fellowship programs.Our inaugural summer fellowship cohort has already achieved significant milestones, including the publication of a spotlight paper at the Mechanistic Interpretability Workshop at NeurIPS and accepted papers at ICLR, with some fellows securing positions at Goodfire and Redwood Research. Following a successful launch in 2025, we are poised for rapid growth in 2026, planning to host multiple fellowship cycles (Fall, Spring, and Summer), double the fellowship cohort, and quadruple our team.Refer us candidates, and receive a $5,000 reward if they are hired.The RoleAs the Fellowship Operations Associate, you will be integral to the operational framework of CBAI's fellowship programs, ensuring that fellows, mentors, and staff can perform at their best without obstacles. Your responsibilities will encompass daily logistics, such as coordinating meals and A/V setups for speaker events, as well as organizing social and community events that make CBAI an attractive place to work. You will manage vendor relationships, coordinate spaces and resources across fellowship cycles, and guarantee the smooth execution of all events, from informal reading groups to full-cohort poster days. This position offers a high level of ownership and visibility; when operations run smoothly, the impact is evident, and when challenges arise, you will be the problem-solver.Fellowship Operations (0.7 FTE)Oversee daily operational logistics during active fellowship cycles, including meal coordination, A/V setup for speaker events, and collaboration with the Operations Site Manager at our Harvard Square officeSource, book, and manage venues for fellowship events, including workshops, speaker series, poster days, and other program milestonesCoordinate travel and accommodation arrangements for visiting speakers and mentorsManage relationships with vendors and contractors, including sourcing new vendors, negotiating terms, and ensuring quality and reliability over timeProcure and manage supplies, equipment, and resources necessary to support fellows and staff

At Aditum Bio, we are dedicated to providing patients with access to transformative medicines. Co-founded by industry leaders Joe Jimenez, former CEO of Novartis, and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, our firm explores scientific avenues with significant medical implications and seeks drug candidates that meet these opportunities. What sets Aditum apart is our commitment not only to identifying and licensing drug candidates but also to defining, preparing for, and conducting the initial definitive clinical trials.Position Summary:The Senior Associate will collaborate closely with Aditum Bio partners to identify promising investment opportunities and facilitate the due diligence processes related to these opportunities, including modeling and simulation. This role is critical throughout the investment lifecycle, from defining initial areas of interest to assisting in diligence, deal negotiations, and new company formation.Specific Responsibilities:Research and propose potential investment ideas. The Senior Associate will explore various pathways and indications, develop investment theses, and validate these with Aditum Partners, Advisors, and externally curated experts.Conduct research to uncover new investment opportunities. The Associate will engage with key contacts and prospects to evaluate drug assets that may interest the Aditum Bio investment team.Participate in scientific review panels: Collaborate with Aditum Bio partners and scientific advisors to discuss interim findings and utilize feedback to refine research and recommendations.Manage deal diligence and transactions: Perform due diligence on therapies of interest, including scientific, clinical, and financial evaluations. Work alongside Aditum Bio experts to develop clinical strategies, development plans, and budgets. Present findings to the Aditum Bio Investment Committee and collaborate with external partners on deal discussions and transactions.Lead new company incubation and operations: Assist in the incubation of new companies and operational activities.

About the Role farsyt is looking for a Senior Insurance Producer in Cambridge, MA. This position focuses on building strong client relationships, understanding each client’s insurance needs, and recommending solutions that support their financial well-being. What You Will Do Develop and maintain relationships with clients, both new and existing Assess client insurance requirements and recommend appropriate coverage options Support clients throughout the insurance process, ensuring clear communication and reliable service Contribute to business growth by identifying opportunities to expand client portfolios

Join the dynamic team at the Center for Education Policy Research (CEPR) at Harvard University as a Senior Research Analyst (SRA). CEPR is dedicated to revolutionizing education through rigorous research and data-driven decisions, ensuring that educational leaders make informed choices that benefit all students. As part of our commitment to advancing academic success, the SRA will play a pivotal role in analyzing educational trends and outcomes across the nation.The Senior Research Analyst will oversee and contribute to vital research initiatives focused on various educational subjects, including college and career readiness, effective literacy strategies, high-quality curricula, charter school evaluation, and the impact of educational technology. The findings from these studies will not only enhance student performance but will also drive a paradigm shift in data utilization within the education sector. Responsibilities will encompass developing analytic plans, proposing research projects, conducting independent analyses with minimal oversight, crafting reports for diverse audiences, leading technical presentations, and supporting grant applications.Key Responsibilities:Research Analysis:Initiate and lead innovative research analyses by formulating research questions, identifying policies for evaluation, and determining suitable methodologies.Create detailed pre-analysis plans that outline key variables and deliverables, fostering transparency and alignment with open science standards.Collect and respond to feedback from faculty and senior researchers to refine research processes.Manage and process extensive longitudinal datasets, ensuring data quality and integrity.Contribute to the education field by providing insightful analyses and actionable recommendations.

Your Impact at Lila Sciences Join our innovative high-throughput autonomous chemistry team as a Senior Research Associate / Associate Scientist. This hands-on position bridges the fields of organic and inorganic synthesis, advanced characterization, and laboratory automation. You will design and implement high-throughput experiments, synthesize small molecules, and conduct thorough downstream analysis alongside senior scientists. Your efforts will contribute to translating ambitious product objectives into scalable experimental workflows that significantly influence our company's growth. This role provides a unique opportunity to engage with automated chemistry platforms, giving you real ownership of experiments that shape our scientific strategy and direction. Ideal candidates are execution-oriented, excel in dynamic laboratory settings, and are passionate about developing deep technical skills while making impactful contributions to the future of chemical discovery at Lila Sciences. What You’ll Be Building Independently conduct experiments for the synthesis, purification, and characterization of organic and inorganic small molecules. Optimize reactions, develop methodologies, and analyze analytical data to inform project decisions. Convert initial concepts into reliable, functional experiments. Utilize retrosynthetic analysis to assist in the synthesis of target molecules. Operate Schlenk lines, gloveboxes, and various inert-atmosphere systems for sensitive materials. Employ PAT tools (UPLC, LCMS, NMR, IR, Fluorescence, DLS) to monitor reactions, ensure quality control, and produce high-quality data for machine learning workflows. Leverage automation and AI-driven technologies to streamline workflows and reduce experimental turnaround times. Collaborate with engineers, ML scientists, and stakeholders to validate model-recommended conditions, analyze trends, troubleshoot challenges, and clearly communicate results through reports, discussions, and presentations. Maintain meticulous documentation of results, ensuring accurate digital records while adhering to EHS and laboratory best practices. What You’ll Need to Succeed M.S. in Chemistry or a related field (such as organic, organometallics, or catalysis) with a minimum of 2 years of relevant laboratory experience, or a B.S. with 5 years of experience. Hands-on experience in organic and inorganic synthesis, purification processes, chromatographic techniques, and product analysis. Strong grasp of retrosynthesis, reaction mechanisms, and method optimization workflows. Proficiency in utilizing laboratory automation tools and systems. Excellent problem-solving skills and the ability to work collaboratively in a team-oriented environment.

Lila Sciences seeks an Associate Engineer to join the Research Operations team in Cambridge, MA. This team develops high-throughput methods that support scientific discovery across multiple disciplines. The position centers on hands-on work with materials characterization, using advanced tools such as spectroscopy and microscopy. This role provides direct exposure to automation technologies while supporting projects that influence the company’s direction. It suits candidates interested in expanding their engineering skills and building a strong base in scientific operations. Key responsibilities Perform materials characterization using SEMXRF, XRD, Optical Microscopy, Nanoindentation, and Profilometry. Prepare reagents, solutions, electrolytes, samples, and consumables to support experiments across shifts. Follow standard operating procedures to maintain accuracy and consistency. Monitor workflow, troubleshoot routine issues, and escalate concerns to keep operations steady between shifts. Record and organize experimental data with care. Identify and suggest ways to improve efficiency and streamline shift operations. Report unusual results or observations to scientists for review. Collaborate with scientists and engineers on projects spanning life sciences and physical sciences. Location This position is based in Cambridge, MA, USA.

About Serif Biomedicines, Inc. Serif Biomedicines, Inc. is a privately held biotechnology company based in Cambridge, MA. The team focuses on developing gene therapies for diseases that currently lack effective treatments. Founded by Flagship Pioneering, Serif is part of a network that has launched over 100 companies in the life sciences, including Moderna, Syros Pharmaceuticals, and Generate Biomedicines. Position Overview The Research Associate in Molecular Biology will contribute to the development of programmable medicines. This position suits a molecular virologist or biochemist with hands-on experience in nucleic acid production, characterization, and molecular cloning. Scientific rigor and a collaborative approach are essential. The role involves working closely with others to advance nucleic acid therapeutics in a setting that values curiosity and innovation. Main Responsibilities Plasmid Production: Design, carry out, and troubleshoot molecular cloning for inserts of various lengths and compositions. Ensure plasmid sequences meet specifications. Inventory Management: Organize storage of produced materials. Keep accurate electronic records of material details and storage locations. Enzymatic Reaction Optimization: Improve and troubleshoot enzymatic reactions to boost nucleic acid yield and purity. Nucleic Acid Production: Follow and refine protocols to produce high-quality DNA and RNA with different expression cassettes.