Associate Director of Regulatory Affairs

AbbVie is seeking a highly skilled Associate Director to lead our Safety Operations Portfolio. This pivotal role involves overseeing safety operations while ensuring compliance with regulatory requirements. The ideal candidate will possess exceptional leadership skills and a strong background in pharmacovigilance.Join our dynamic team and contribute to advancing healthcare solutions that enhance patient safety and improve health outcomes. This is an exciting opportunity for professionals looking to make a meaningful impact in the pharmaceutical industry.

We are seeking a highly skilled Associate Director of Drug Safety and Pharmacovigilance to join our dynamic team at Nuvalent. This pivotal role involves overseeing drug safety operations, ensuring compliance with regulatory requirements, and enhancing the pharmacovigilance strategy. The ideal candidate will possess a deep understanding of drug safety processes and a passion for advancing patient safety in the pharmaceutical industry.

Nuvalent seeks an Associate Director of Clinical Operations to join the team in Cambridge, MA or work remotely. This leadership role guides the execution of clinical trials, ensuring every step aligns with regulatory standards and internal protocols. The position partners with cross-functional teams to develop and deliver on clinical strategies, overseeing studies from planning through closeout. What you will do Direct clinical trial operations for multiple concurrent studies Maintain compliance with all regulatory requirements and company procedures Work closely with colleagues across departments to create and implement clinical strategies Supervise all aspects of study management, from initiation to completion Oversee budgets, timelines, and resource planning for clinical programs Mentor and guide junior staff within clinical operations Requirements Significant experience in clinical operations and project management Background working in pharmaceutical or biotechnology organizations Demonstrated ability to manage budgets and timelines Experience mentoring or managing team members

The Harvard Institutes for Higher Education is seeking a dynamic and experienced Portfolio Director to lead and enhance our portfolio of educational programs. In this pivotal role, you will oversee the strategic development and implementation of innovative initiatives that align with our mission to advance higher education leadership. As a visionary leader, you will collaborate with various stakeholders to ensure program excellence and sustainability.

As a Drug Safety Associate at Integrated Resources Inc., you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. You will be responsible for monitoring and evaluating adverse events, coordinating safety reports, and contributing to the overall pharmacovigilance efforts within our organization. Your attention to detail and analytical skills will be vital in supporting our commitment to patient safety.

Scholar Rock, Inc. is a pioneering biopharmaceutical firm dedicated to the discovery, development, and delivery of transformative therapies for individuals suffering from serious diseases with significant unmet medical needs. As a recognized leader in the biology of the transforming growth factor beta (TGFβ) superfamily of proteins, Scholar Rock is committed to advancing innovative treatments where the modulation of protein growth factors is crucial. Over the last decade, we have developed a robust pipeline aimed at redefining the standard of care for neuromuscular conditions, cardiometabolic disorders, cancer, and other diseases where growth factor-targeted therapies can radically change patient outcomes. Scholar Rock is the first and only company to demonstrate clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). Our commitment to unlocking unique therapeutic strategies is driven by our proprietary platform, which has generated novel monoclonal antibodies designed to modulate protein growth factors with remarkable precision. By leveraging cutting-edge scientific advancements in therapeutic areas that have historically been overlooked by conventional treatments, Scholar Rock tirelessly works to create new avenues for patient care. Discover more about our innovative approach at ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:The Senior Medical Director of Drug Safety & Pharmacovigilance plays a critical role within the company, significantly influencing the development and lifecycle management of drug projects. This position is responsible for defining and implementing safety strategies and providing expert guidance during both pre- and post-approval phases for assigned products. The Senior Medical Director will proactively lead risk management initiatives in compliance with global regulatory standards, continuously evaluating safety data, conducting signal detection, and managing the safety profiles of compounds. Additionally, this role will involve close collaboration with cross-functional teams to achieve project objectives within established timelines and quality standards.

Join Integrated Resources Inc. as a Senior Drug Safety Associate and contribute to the vital field of drug safety and pharmacovigilance. In this role, you will play a key part in monitoring and ensuring the safety of pharmaceutical products, working closely with cross-functional teams to assess risk and implement safety measures.

Join the Cambridge Boston Alignment InitiativeThe Cambridge Boston Alignment Initiative (CBAI) is a nonprofit organization dedicated to pioneering research and educational initiatives aimed at ensuring a safe and beneficial transition to advanced AI systems. Our mission focuses on producing original research and accelerating AI safety through comprehensive fellowship programs.Since our initial summer fellowship cohort, we have achieved significant milestones, including published papers at prominent conferences such as NeurIPS and ICLR. As we enter 2026, we are poised for rapid growth, planning multiple fellowship cycles and expanding our team significantly.Refer candidates to us, and if hired, you will receive a $5,000 referral bonus!Your RoleAs a Research Program Associate, you will collaborate closely with Research Managers, mentors, and program leadership to design and refine the frameworks that empower fellows to excel in their research. This is a pivotal program-building position where you will create systems for mentor matching, research goal tracking, progress assessment, and problem-solving support for fellows.Program Design & Development (0.6 FTE)Enhance CBAI's fellow selection process and program deliverables.Identify effective outreach channels and manage outreach campaigns for future iterations.Develop evaluation frameworks to assess fellow progress and program effectiveness.Implement structural improvements based on feedback from fellows, mentors, and research managers.Assist in the planning and execution of fellowship events, such as speaker series and poster days.Fellow & Mentor Experience (0.4 FTE)Design and oversee the onboarding process for mentors, ensuring a positive experience.

Join Integrated Resources Inc. as an Operations Associate, where your skills will contribute to optimizing and enhancing our operational processes. In this role, you will assist in streamlining workflows, supporting project management efforts, and ensuring the efficient execution of daily operations. Your proactive approach and attention to detail will be crucial in helping us achieve our organizational goals.

Join Harvard University as the Director of Operations in the Campus Services - Harvard Dining & Hospitality department. This pivotal role will oversee the operations of dining and hospitality services, ensuring the highest standards of service and efficiency. The Director will lead a team, develop operational strategies, and drive initiatives that enhance the overall experience of our campus community.

We are seeking a highly motivated and experienced Director of Operations to join The People Lab at Harvard University. In this pivotal role, you will lead operational strategies, manage resources, and ensure the seamless execution of projects that enhance our research capabilities. Your expertise will drive innovation and efficiency across our operations, positioning us as a leader in the field.

Join our dynamic team at Integrated Resources Inc. as a Senior Operations Associate. In this pivotal role, you will be responsible for optimizing operational processes and enhancing productivity. Collaborate with cross-functional teams to drive continuous improvement initiatives and deliver exceptional results. Your analytical mindset and problem-solving skills will be crucial in identifying opportunities for operational efficiencies.

Join our dynamic team at Integrated Resources, Inc. as an Associate Director of Pharmacovigilance. In this pivotal role, you will oversee the safety and efficacy of pharmaceutical products, ensuring compliance with regulatory standards and advancing our commitment to patient safety.Your expertise in pharmacovigilance will guide our strategic initiatives, collaborating with cross-functional teams to enhance product safety and regulatory submission processes.

Role Overview Harvard University is seeking an Associate Director of Strategic Sourcing in IT to guide procurement strategy for technology resources. This role leads sourcing projects, negotiates contracts, and works closely with IT teams to secure the right solutions for the university’s technology needs. Key Responsibilities Lead strategic sourcing initiatives for IT products and services Negotiate contracts and manage supplier relationships Collaborate with IT departments to understand requirements and align procurement efforts Support efficiency and innovation in technology sourcing Impact This position plays a direct role in supporting Harvard’s mission by ensuring access to effective and reliable technology resources. Strategic sourcing decisions will help drive operational efficiency and support ongoing innovation across the university.

Join Amylyx Pharmaceuticals as the Senior Director of Trade and Channel Operations, where you will lead strategic initiatives to optimize our trade and channel strategies. In this pivotal role, you will be responsible for driving operational excellence, enhancing partnerships, and ensuring the effective distribution of our innovative therapies. Collaborate with cross-functional teams to develop and implement best practices that amplify our market presence and improve patient access to our products.

As the Director of Accounting Operations at Scholar Rock, you will be at the forefront of our financial strategies, leading a dynamic team to enhance our accounting practices. Your expertise will drive the efficiency and accuracy of our financial operations, ensuring compliance with regulations and supporting our growth objectives. You will collaborate with cross-functional teams, providing insightful financial analysis and fostering a culture of financial accountability.

Harvard University is seeking an innovative and strategic Associate Director of Research to lead groundbreaking research initiatives. The ideal candidate will possess a deep understanding of research methodologies, strong leadership skills, and a passion for academic excellence. This role involves collaborating with faculty and students to enhance research output and drive impactful scholarship.

COMPANY DESCRIPTION Flagship Pioneering is a leading platform for innovation that not only invents but also builds transformative companies that aim to change the world. By uniting some of the most brilliant scientific minds with entrepreneurial builders and the necessary capital, we empower them to make bold advancements. Our efforts catalyze progress in crucial areas such as healthcare, sustainability, and beyond, driving scientific breakthroughs ranging from disease detection and treatment to sustainable agriculture and innovative AI applications. What distinguishes Flagship is our unique ability to propel science and technology forward by integrating innovation, company creation, and capital investment into a cohesive process that is largely unprecedented. Our team of scientific founders, entrepreneurial leaders, and professional capital managers collaborate through a systematic approach designed to foster innovation and transformation for the benefit of humanity and the planet. Many of the companies we have established have tackled some of humanity's most pressing challenges, including vaccinating billions against COVID-19, curing chronic diseases, enhancing human health, preventing illnesses, and improving agricultural resilience and sustainability. Flagship has received accolades on FORTUNE’s “Change the World” list for two consecutive years and has been recognized on Fast Company’s list of the World’s Most Innovative Companies. THE ROLE We are on the lookout for a highly motivated, proactive, and detail-oriented Laboratory Operations Associate to become a vital part of our rapidly expanding team. This role involves supporting our research team by managing laboratory operations and ensuring safety protocols are followed, while also addressing day-to-day operational needs and implementing best practices within the lab. The ideal candidate will assist in optimizing R&D operations, support purchasing processes, and contribute to ongoing projects. A high degree of organization, adaptability to a fast-paced entrepreneurial environment, and strong collaboration skills are essential.

Company Overview Fulcrum Therapeutics is an innovative clinical-stage biopharmaceutical organization dedicated to enhancing the quality of life for patients suffering from genetically defined rare diseases that exhibit a significant unmet medical need. Our proprietary product engine is adept at identifying drug targets capable of modulating gene expression to address the underlying causes of gene misexpression. We are currently advancing our flagship asset, FTX-6058 (pociredir), a small molecule engineered to elevate fetal hemoglobin expression for the treatment of sickle cell disease and beta thalassemia. Position Summary The Associate Director of Clinical Science will collaborate closely with the Executive Medical Director and VP of Clinical Development to provide critical support across one or more Clinical Project Teams at Fulcrum Therapeutics. This role is pivotal in ensuring the effective design and execution of Clinical Development Plans, focusing on crafting cost-efficient clinical trials that fulfill the needs of both internal and external stakeholders. The successful candidate will assume responsibility for the scientific oversight of clinical studies, working in partnership with study program leadership and cross-functional team members. This includes the interpretation and communication of clinical trial data, which are crucial for high-quality regulatory submissions. Key responsibilities encompass contributing to the design and execution of company-sponsored clinical trials at all developmental phases, analyzing clinical trial data, and facilitating internal and external communications regarding project plans and progress. The Associate Director will also be involved in safety monitoring and mitigation strategies, as well as making significant contributions to regulatory submissions, publications, and communications of clinical data.