Associate Director of Clinical Operations

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.

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases with significant unmet needs. Where others perceive obstacles, we recognize opportunities that we pursue with a sense of urgency, scientific rigor, and steadfast dedication to the communities we serve. Our focus is currently on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on the commitment of our team. Our core values—be audacious, be curious, be authentic, be engaged, and be accountable—foster a culture of care. At Amylyx, we have assembled a highly skilled team eager to take decisive action because the communities we support cannot afford to wait. If you share our enthusiasm and are committed to addressing some of the most challenging problems in medicine, we invite you to explore the opportunity below and submit your application.The OpportunityThe Director of Clinical Sciences will play a pivotal role within the Clinical Development team, providing essential scientific guidance for ongoing projects. This position reports to a Medical Director and involves cross-functional collaboration with R&D, program management, clinical operations, biostatistics, and data management. The candidate will support and propel key developmental efforts for clinical studies and the execution of the overall Clinical Development Plans (CDP).

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases that have significant unmet needs. While others may see obstacles, we actively pursue opportunities with urgency, rigorous scientific methods, and a steadfast commitment to the communities we serve. As a clinical-stage company, we are currently targeting conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission is driven by our talented team, united by core values that include being audacious, curious, authentic, engaged, and accountable, fostering a culture of compassion. At Amylyx, we have assembled a highly experienced group dedicated to action, as the communities we serve cannot afford to wait. If you share our passion and are committed to addressing some of the most challenging problems in medicine, we invite you to explore this opportunity and apply.The OpportunityThe Clinical Data Management team at Amylyx Pharmaceuticals is in search of an Associate Director, Clinical Data Programmer. In this role, you will collaborate across functions to deliver hands-on data management support, programming expertise, and technical leadership. You will be responsible for developing, maintaining, and validating clinical databases, as well as executing computer programs to access, visualize, and report clinical trial data, adhering to clinical plans, ICH guidelines, and regulatory standards. As the Associate Director of Clinical Data Programming, proficiency in programming languages is essential for creating both textual and graphical representations that facilitate data cleaning and review.

At Iterative Health, we are pioneering healthcare technology and services that accelerate clinical research to enhance patient outcomes. Our Iterative Health Site Network comprises over 70 premier clinical research facilities across the US and Europe, dedicated to expediting the market introduction of innovative therapies for gastrointestinal (GI) and hepatology conditions. We are committed to bolstering the success of our partner sites by equipping them with tech-driven services. By merging extensive expertise in clinical trials with advanced AI technology, we empower research teams and study sponsors to broaden and accelerate access to groundbreaking therapeutics for patients in need.About the RoleWe are redefining clinical trial methodologies in Inflammatory Bowel Disease (IBD), and we are on the lookout for a dynamic commercial leader to amplify our impact. As the Director of Life Sciences, you will steer the next phase of Iterative Health’s growth within the biopharma and biotech sectors, cultivating and expanding relationships with our key sponsors.This role is highly visible and client-centric, tailored for a strategic builder who excels at creating value within intricate partnerships, influencing senior stakeholders, and achieving significant outcomes. You will serve as the crucial link between sponsors and Iterative Health’s internal teams, ensuring we meet all commitments while adapting our solutions to the evolving landscape of clinical research.This position is perfect for a relationship-focused commercial leader who thrives in fast-paced environments and enjoys fostering deep, strategic collaborations within the life sciences domain.

Imagine a scenario where you could be a part of a pioneering organization that not only creates but also nurtures life sciences companies dedicated to pioneering transformative technologies in healthcare and sustainability.Montai Therapeutics is a forward-thinking, privately held biotechnology firm that leverages artificial intelligence to unlock the potential of diverse chemistry, aiming to develop innovative oral medicines that effectively address longstanding unmet needs in chronic diseases. Through our cutting-edge CONECTA™ platform, we have established the world's premier foundation models that decode the intricate relationship between nature's bioactive chemistry and human biology, thus revolutionizing the drug discovery process with unmatched versatility and predictability.We have meticulously curated a collection of over 1 billion Anthromolecules™ and Anthrologs™, derived from compounds that humans have historically consumed through food, supplements, and herbal remedies. This extensive database has provided us with efficient access to a vast array of chemical diversity, enabling us to selectively and precisely influence complex biological systems. Montai is rapidly progressing a pipeline of groundbreaking oral medications targeting validated biological pathways in inflammation and immunology, with a focus on developing biologic replacements for traditionally challenging transcription factors.Position Overview:We are actively seeking a seasoned Head of Clinical Development to report directly to our Chief Executive Officer. This individual will hold primary responsibility for the strategic development and implementation of clinical programs for small molecules within the therapeutic realms of immunology and inflammation at Montai Therapeutics. We invite applications from highly motivated, collaborative, and results-driven professionals who possess the adaptability, creativity, and resourcefulness necessary to thrive in our dynamic environment.The Head of Clinical Development will be instrumental in steering the seamless transition of programs from research to clinical phases, as well as shaping comprehensive clinical strategies that encompass everything from candidate discovery to human proof-of-concept trials. As a pivotal leader in our clinical development efforts, this role involves the formulation and integration of clinical development plans that align with our research, translational, nonclinical, regulatory, and strategic goals. Additionally, this individual will oversee the teams responsible for supporting program operations, resource allocation, and interactions with both internal governance and external partners. This role is ideal for an experienced professional who is passionate about transforming innovative scientific discoveries into groundbreaking therapies through meticulous and collaborative planning and execution.

We are seeking a highly skilled and experienced Director of Clinical Quality to join our dynamic team at Integrated Resources, Inc. In this pivotal role, you will be responsible for overseeing the clinical quality management systems, ensuring compliance with regulatory standards, and driving continuous improvement in clinical processes.Your leadership will be vital in fostering a culture of quality and safety, collaborating with multidisciplinary teams to enhance patient outcomes and operational efficiency.

Your Impact at Lila Sciences Lila Sciences is seeking a dynamic and visionary Director of Product, Life Sciences to lead our innovative product strategies. In this pivotal role, reporting directly to the Vice President of Life Science Product, you will be at the forefront of enhancing our therapeutic research and development capabilities, shaping the future of drug discovery, chemical synthesis, and scientific intelligence. What You'll Be Building Steer the strategic direction for developing breakthrough AI solutions in drug discovery, chemical synthesis, and molecular characterization. Convert strategic goals into comprehensive target product profiles (TPPs) and development campaigns that will empower our science and engineering teams to achieve groundbreaking innovations in life sciences. Lead customer and internal-user discovery initiatives, acting as the primary technical liaison between external customers and partners. Pinpoint and cultivate product opportunities driven by real-world discovery challenges, collaborating closely with stakeholders to ensure relevance and maximize downstream value. Transform insights into precise product requirements, acceptance criteria, and experimental plans that will guide our engineering and science teams. Oversee product execution from inception to launch, leading cross-functional teams across various disciplines including science, machine learning, automation, and software engineering. Manage resource allocations effectively (budget, compute, lab access, personnel) against a complex array of priorities. Establish clear success metrics and milestones, communicating progress to the organization, including executive leadership. What You'll Need to Succeed Advanced degree (MS, PhD, or equivalent experience) in medicinal chemistry, chemical biology, chemical engineering, biochemistry, or a related field, with a solid foundation in experimental science. 7+ years of experience in Product Management, particularly in developing new or experimental products in drug discovery, molecular profiling, machine learning, or scientific software development. In-depth understanding of drug development processes, molecular and cellular research tools, as well as wet and dry lab workflows. Experience with small molecule discovery workflows (e.g., lead optimization, ADMET profiling, synthesis planning) is highly preferred.

Join Bicycle Therapeutics, a pioneering biopharmaceutical company, as the Director of Clinical Safety Science specializing in Radiopharmaceuticals. In this critical role, you will lead the evaluation and management of clinical safety data, ensuring the highest standards of patient safety and regulatory compliance. You will collaborate closely with cross-functional teams to drive innovative solutions in our clinical development programs.

Join Ramboll as a Director of Life Science and Pharmaceutical Innovations, where you will play a pivotal role in shaping the future of healthcare. You will lead strategic initiatives, collaborating with a talented team to drive innovation and excellence within the life sciences and pharmaceutical sectors. Your expertise will guide the development of cutting-edge solutions that enhance patient outcomes and streamline processes.

About eGenesiseGenesis is an innovative clinical-stage biotechnology company dedicated to developing human-compatible engineered organs to tackle the critical global organ shortage. Our proprietary genome engineering platform facilitates extensive, multiplex gene edits aimed at removing major biological barriers, incorporating protective human transgenes, and inactivating endogenous retroviruses. Our flagship program, EGEN-2784, a genetically engineered porcine kidney, is currently undergoing evaluation in a multi-patient Expanded Access study at Massachusetts General Hospital (MGH). Headquartered in the vibrant city of Cambridge, MA, eGenesis is at the forefront of pioneering medical solutions.As the Lead Clinical Research Associate, you will spearhead site monitoring activities and oversee Clinical Research Associates (CRAs) for designated clinical trials. Collaborating closely with Clinical Operations leadership and cross-functional teams, you will ensure that studies are executed in strict adherence to protocols, ICH-GCP guidelines, regulatory requirements, and our company Standard Operating Procedures (SOPs).

About BlueRock TherapeuticsBlueRock Therapeutics LP is at the forefront of cell therapy innovation, dedicated to developing groundbreaking treatments for neurological and ophthalmic disorders. Our clinical-stage investigational therapies, including bemdaneprocel (BRT-DA01) for Parkinson’s disease and OpCT-001 for primary photoreceptor diseases, represent a significant leap in medical science. Founded in 2016 through a partnership between Versant Ventures and Leaps by Bayer, we are driven by a culture of resilience, urgency for transformation, integrity, and a deep commitment to community.Our VisionWe specialize in harnessing the potential of universal pluripotent stem cells, guiding their differentiation into functional cells for allogeneic cellular therapies aimed at a wide range of conditions. Our passion lies in advancing cellular and gene therapy, ultimately improving the lives of millions of patients by delivering innovative treatment options.We are on the lookout for dynamic individuals who thrive in a collaborative and vibrant environment, and who are dedicated to pioneering cellular therapies that can transform patient outcomes.As we continue to make strides in cellular therapies, we are inviting an exceptional professional to join our Clinical Development team, playing a crucial role in overseeing preclinical, translational IND-enabling, and clinical development activities for our neurology programs.The Associate Medical Director of Neurology will lead scientific and medical initiatives for our neurology programs. Reporting directly to the Vice President of Clinical Development, this individual will collaborate closely with program leads and subject matter experts to enhance our development pipeline. The ideal candidate will serve as a clinical and scientific authority, fostering both internal and external partnerships to drive program success.

Join Lila Sciences as a Senior Research Associate or Associate Scientist in the Protein Science department, focusing on our cutting-edge Antibody Platform. You will play a crucial role in advancing our research initiatives, contributing to the development of innovative antibody-based therapeutics. This position offers the opportunity to collaborate with a talented team dedicated to scientific excellence and the pursuit of transformative solutions in healthcare.

Scholar Rock is a pioneering biopharmaceutical company dedicated to the discovery, development, and delivery of transformative therapies for patients suffering from serious diseases with significant unmet medical needs. As a global frontrunner in the understanding of the transforming growth factor beta (TGFβ) superfamily of cell proteins, Scholar Rock is aptly named for the visual resemblance of a scholar rock to protein structures. The company is currently in the clinical stage, focusing on advancing groundbreaking treatments that leverage protein growth factors to create better health outcomes. Over the past decade, Scholar Rock has cultivated a robust pipeline aimed at improving the standard of care for conditions such as neuromuscular diseases, cardiometabolic disorders, cancer, and other areas where growth factor-targeted therapies could effectuate significant change. Scholar Rock stands out as the sole company to demonstrate clinical proof of concept for a muscle-targeted treatment for spinal muscular atrophy (SMA). We are committed to pioneering fundamentally different therapeutic approaches, supported by our proprietary platform that has developed novel monoclonal antibodies capable of exquisitely modulating protein growth factors. By utilizing cutting-edge scientific advancements in disease areas that have been historically underserved by conventional therapies, Scholar Rock is dedicated to unlocking new possibilities for patients. To learn more about our innovative approach, visit ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:The Medical Director/Senior Director will report directly to the Senior Vice President of Clinical Research and will play a crucial role within the late-stage development team. This individual will be responsible for overseeing the clinical development activities for product candidates, guiding them from Proof-of-Concept through to marketing approval and ongoing lifecycle management. The ideal candidate will provide medical leadership for the clinical development of apitegromab and other late-stage product candidates in accordance with the overall corporate strategy. This role requires an enthusiastic physician-scientist with substantial hands-on experience in advancing late-stage product candidates to deliver revolutionary therapies.

Join our dynamic team as a Clinical Trial Leader, where you will be at the forefront of innovative clinical research. You will be responsible for overseeing the planning, execution, and management of clinical trials, ensuring compliance with all regulatory requirements and organizational standards. Your leadership will guide cross-functional teams to deliver high-quality results, contributing to the advancement of healthcare solutions.

Your Role at Lila Sciences Lila Sciences is searching for a skilled Senior Research Associate with expertise in Protein Purification, Analytics, and Developability. You will play a crucial role in the establishment and daily functioning of a cutting-edge high-throughput protein characterization platform. This position involves optimizing biophysical characterization workflows, collaborating with cross-functional teams, and ensuring the generation of high-quality, reproducible data as you contribute to the advancement of Lila's Scientific Superintelligence platform. Key Responsibilities Execute and refine high-throughput workflows for protein characterization across various modalities, including antibodies, bi-specifics, and enzymes. Operate and maintain automated chromatography systems, utilizing Size Exclusion Chromatography (SEC), Hydrophobic Interaction Chromatography (HIC), and affinity chromatography via HPLC platforms. Conduct biophysical characterization using advanced techniques such as Dynamic Light Scattering (DLS), melting temperature analysis (DSF), binding assays (BLI/SPR), and capillary electrophoresis (CE-SDS, cIEF) to evaluate protein critical quality attributes. Support workflows for characterizing protein post-translational modifications (PTMs), ensuring thorough sample preparation and precise data capture. Collaborate with scientists, engineers, and automation specialists to identify and implement enhancements in the efficiency, robustness, and scalability of developability workflows. Innovate and adjust protocols to accommodate new protein formats, targets, and analytical strategies. Ensure rigorous data quality, documentation, and reproducibility in all experiments; actively participate in knowledge sharing and continuous improvement initiatives. Work closely with computational scientists to support data analysis pipelines, data processing, and the creation of predictive models for protein characteristics.

Join Integrated Resources, Inc. as an Associate Director of Trial Master File Management, where you will play a pivotal role in overseeing the integrity and management of trial documents. You will be responsible for ensuring compliance with regulatory standards and optimizing document workflows to enhance trial efficiency.

Make a Significant Impact at Lila Sciences Lila Sciences is actively seeking a dynamic Associate Director or Director of Program Management in the Life Sciences sector. This pivotal role is designed for an experienced leader who will spearhead the planning, execution, and successful delivery of therapeutic programs within Lila's innovative platform. The successful candidate will directly manage projects across internal science, engineering, and automation teams dedicated to developing molecules for our partners, ensuring timelines, resource allocation, and progress tracking are meticulously maintained across diverse, multidisciplinary programs. In this capacity, you will also act as a key operational liaison with our pharmaceutical and biotech partners, guaranteeing seamless governance, communication, and delivery of project milestones. These programs involve significant scientific complexity and commercial importance, necessitating a proactive approach to driving execution in fast-paced, technically challenging environments while adeptly managing partner relationships and expectations. Your Responsibilities Lead comprehensive project management for active therapeutic initiatives, overseeing timeline development, resource coordination, milestone tracking, and dependency management among product, science, machine learning, and automation teams. Instill a sense of discipline in day-to-day execution, ensuring internal teams are aligned with clear priorities and deliverables, while swiftly addressing any identified blockers. Facilitate discussions regarding resource allocation and make trade-off decisions across a complex landscape of priorities, such as balancing AI model training experiments with immediate partnership deliverables. Create and uphold program-level reporting structures, including status updates, milestone tracking, and resource utilization insights for both internal leadership and external stakeholders. Proactively identify, communicate, and manage program risks, escalating issues as necessary and maintaining transparency with scientific and executive leadership. Organize and lead effective internal program meetings, decision-making forums, and reviews, ensuring the right information is disseminated to the appropriate stakeholders in a timely manner. Partner Engagement Act as the primary operational interface with partner organizations, coordinating joint governance, managing deliverable timelines, and fostering alignment on project milestones and expectations. Translate internal program statuses into structured updates for external partners, ensuring clarity while preserving internal complexities. Support alliance obligations, including participation in joint steering committees, milestone reporting, and deliverable handoffs.

Join Integrated Resources, Inc. as a Pharmaceutical Research Associate, where you will play a vital role in advancing medical research and drug development. You will collaborate with a team of scientists and researchers to assist in the design and execution of clinical trials, ensuring the integrity and accuracy of data collection.Your contributions will help pave the way for innovative therapies that make a difference in patients' lives. Ideal candidates are detail-oriented, possess strong analytical skills, and have a passion for the pharmaceutical industry.

Join Integrated Resources Inc. as a Clinical Associate, where you will play a vital role in supporting our budgeting and forecasting efforts within the healthcare sector. We are looking for a detail-oriented professional who is passionate about improving healthcare outcomes through effective financial analysis.