Director of Clinical Quality

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.

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.

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.

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

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).

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.

Scholar Rock is a pioneering biopharmaceutical company dedicated to discovering, developing, and delivering transformative therapies for individuals battling serious diseases with significant unmet needs. Renowned as a global authority in the biology of the transforming growth factor beta (TGFβ) superfamily, our clinical-stage organization is passionately focused on advancing innovative treatments that are fundamentally reliant on protein growth factors. Over the last decade, we have cultivated a robust pipeline aimed at elevating the standard of care for neuromuscular diseases, cardiometabolic disorders, cancer, and various conditions where growth factor-targeted drugs can have a revolutionary impact. Scholar Rock proudly stands as the sole company to have demonstrated clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our commitment to unlocking novel therapeutic avenues is driven by the extensive application of a proprietary platform that has developed unique monoclonal antibodies designed to modulate protein growth factors with remarkable precision. By leveraging cutting-edge science in disease areas that have traditionally been overlooked by conventional therapies, we strive each day to create new possibilities for patients. To learn more about our innovative approach, visit ScholarRock.com and follow us on Twitter and LinkedIn.Position Overview:We are actively seeking a highly experienced and driven Senior Director of Global Quality Control to join our team. This pivotal role reports directly to the Head of Global Quality and serves as the senior leader responsible for establishing and maintaining a scalable, phase-appropriate, and inspection-ready global QC strategy across a fully outsourced development and manufacturing network. The Senior Director will provide both strategic and technical leadership for Quality Control activities carried out through external contract laboratories, CMOs, and other testing partners, supporting drug substance, drug product, raw materials, in-process, release, and stability programs.

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.

Join Bicycle Therapeutics as a Senior Director of Clinical Data Management, where you will lead innovative data strategies to enhance our clinical trial processes. In this pivotal role, you will oversee the collection, management, and analysis of clinical data, ensuring the highest standards of quality and integrity. Your expertise will guide a dedicated team, driving efficiencies and fostering a culture of continuous improvement.This role is crucial in advancing our mission to develop transformative medicines for patients. Collaborate with cross-functional teams to ensure data strategies align with project goals and regulatory requirements.

Amylyx Pharmaceuticals is on a daring mission to transform the landscape of treatments for diseases with significant unmet needs. We embrace challenges as opportunities, driving forward with urgency, rigorous scientific approaches, and a steadfast commitment to the communities we serve. As a clinical-stage organization, we are currently dedicated to addressing post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission is fueled by our exceptional team. We uphold core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of compassion. At Amylyx, we have assembled a skilled team eager to take decisive action, as the communities we serve cannot afford to wait. If you share our passion and are resolute in tackling some of medicine's most challenging problems, we invite you to explore the opportunity below and apply.The OpportunityAmylyx is seeking a Senior Medical Director, Clinical Development to deliver strategic and scientific leadership for one or more late-stage, pivotal programs with the possibility of expanding into additional indications and/or programs within the same molecule or across our portfolio. This role is pivotal in shaping the overall clinical development strategy and may oversee multiple programs or key components of a broader development portfolio.Reporting directly to the Senior VP of Clinical Development, you will be tasked with leading the design, execution, and analysis of clinical studies and managing the development and implementation of Clinical Development Plans across assigned assets. Your strategic input will be crucial in study design, endpoints, and regulatory strategies, ensuring alignment with overall program and corporate objectives.The ideal candidate will work collaboratively with cross-functional teams in a matrix environment, influencing stakeholders across Research, Regulatory Affairs, Clinical Operations, and Commercial to ensure that clinical and scientific considerations are fully integrated into development plans. You will proactively identify and mitigate risks, guide decision-making through data-driven insights, and uphold the highest standards of scientific rigor and data integrity.In this capacity, you will also act as a key external representative, engaging with global medical experts, investigators, regulatory authorities, and alliance partners. You may lead or mentor a team of clinical scientists and physicians and contribute to broader organizational and portfolio-level initiatives.

Iterative Health is a pioneering healthcare technology and services company dedicated to revolutionizing clinical research and enhancing patient outcomes. With an extensive network of over 70 clinical research sites in the U.S. and Europe, we are at the forefront of accelerating the market introduction of innovative gastrointestinal (GI) and hepatology therapies. Our mission is to empower our partner sites through advanced tech-enabled services, leveraging our deep expertise in clinical trials and state-of-the-art AI to broaden access to groundbreaking therapeutics for patients in need.About the RoleThe Regional Director will lead and enhance the performance of GI-focused clinical research sites within their portfolio. This role is crucial in ensuring operational excellence, aligning teams to achieve key performance metrics, elevating site capabilities, and maintaining consistency in trial execution. As a strategic leader in operations, the Regional Director will bridge site performance with overarching business objectives.ResponsibilitiesOversee staff across multiple sites, ensuring alignment with protocols, regulatory standards, and Iterative Health's guidelines.Take full ownership of site performance, encompassing recruitment, data integrity, compliance, and team culture.Ensure sites are optimally prepared for success through adequate staffing, equipment, and training, providing recommendations for resource allocation based on business needs.Foster strong partnerships with Principal Investigators (PIs) to align their engagement with study objectives and operational strategies.Influence the study portfolio to enhance profitability and patient value.Proactively identify and address issues related to site performance.Guide and develop Clinical Research Coordinators (CRCs) and site-based research personnel through clear expectations, performance coaching, and team development.Act as a visible and hands-on leader, cultivating high-performing, accountable teams.Analyze KPIs and monitor performance trends to identify and leverage factors driving site-level success.Implement corrective actions and process enhancements as necessary.Serve as the primary operational liaison between site personnel and central functions.Promote a culture of accountability, collaboration, and continuous improvement throughout all assigned sites.

Scholar Rock is a leading biopharmaceutical firm dedicated to discovering, developing, and delivering transformative therapies for individuals suffering from serious diseases with significant unmet needs. As a pioneer in the understanding of the transforming growth factor beta (TGFβ) superfamily of proteins, we are named for the resemblance of a scholar rock to protein structures. Our clinical-stage organization is committed to advancing groundbreaking treatments where protein growth factors play a crucial role. Over the past decade, we have built a robust pipeline aimed at enhancing the standard of care for neuromuscular diseases, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted treatments can have a profound impact. Scholar Rock stands out as the only company that has demonstrated clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our dedication to pioneering innovative therapeutic approaches is driven by the extensive application of our proprietary platform, which has developed novel monoclonal antibodies to selectively modulate protein growth factors with remarkable precision. By leveraging advanced science in areas historically underserved by conventional therapies, Scholar Rock is consistently working to unlock new possibilities for patients. Discover more about our approach at ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:We are in search of a highly skilled and driven Senior Director of US Quality Assurance to join our team. Reporting directly to the Head of Global Quality, this role will provide both strategic and operational leadership for US Quality Assurance. A strong emphasis will be placed on managing external partner governance, implementing quality risk management strategies, and establishing a scalable quality infrastructure to support our development through commercialization efforts.

Relay Therapeutics is seeking a dynamic and experienced Director of Analytical Development and Quality Control to lead our analytical efforts in drug development. In this leadership role, you will oversee the development and implementation of analytical methods to support our innovative drug discovery pipeline. You will work closely with cross-functional teams to ensure optimal quality control processes and regulatory compliance.Your expertise will play a critical role in driving our mission to improve the lives of patients through cutting-edge therapies.

Join Bluerock Therapeutics as a Senior Director - Clinical Operations Program Leader (COPL) in Ophthalmology. In this pivotal role, you will lead and optimize clinical operations for our ophthalmology programs, ensuring the successful execution of clinical trials and the advancement of innovative therapies.Your responsibilities will include strategic planning, cross-functional leadership, and oversight of clinical study execution, while collaborating closely with internal and external stakeholders.

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.

Amylyx Pharmaceuticals is dedicated to revolutionizing the treatment of diseases with significant unmet needs. We embrace challenges as opportunities, driven by a sense of urgency, rigorous scientific methodology, and a steadfast commitment to the communities we serve. Our focus is on clinical-stage development for conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on our talented team, which embodies core values of audacity, curiosity, authenticity, engagement, and accountability — all of which foster a culture of care. Amylyx has curated a skilled workforce ready to act swiftly because the communities we support cannot afford to wait. If you are passionate about addressing some of the most challenging issues in medicine, we invite you to explore the opportunity below and apply.The OpportunityThe Associate Director of Computer System Validation (CSV) & Quality Compliance will provide enterprise-level leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxP-relevant computerized systems, particularly focusing on the Veeva Quality Suite. This position is pivotal in ensuring that our digital quality solutions and supporting systems comply with global regulatory standards (FDA, EMA, ICH, GAMP 5), safeguard data integrity, and maintain a sustainable, inspection-ready status across the organization.This role entails close collaboration with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, oversee new system implementations and significant enhancements, and promote harmonized, risk-based validation practices. Additionally, this position supervises quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely resolutions, trend analysis, and effective governance through leadership of key forums, including Quality Management Review and cross-functional compliance meetings.

Nuvalent, Inc. is seeking a Senior Director of Clinical Pharmacology to lead our clinical pharmacology team. This pivotal role involves developing and executing clinical pharmacology strategies to support our innovative drug candidates. The ideal candidate will have extensive experience in clinical pharmacology and a passion for advancing novel therapies.

About Fulcrum Therapeutics Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a clinical-stage biopharmaceutical company based in Cambridge, MA. The team focuses on developing small molecule therapies for genetically defined rare diseases, with an emphasis on areas where patients have limited treatment options. The lead program, Pociredir, aims to increase fetal hemoglobin expression as a novel approach for treating sickle cell disease (SCD). Role Summary: Director of Biostatistics The Director of Biostatistics plays a key role within the Biometrics Department and reports to the VP of Biometrics. This position acts as the statistical subject matter expert for Fulcrum’s clinical development programs and individual studies. The director oversees statistical activities for outsourced clinical trials and ensures all work meets regulatory requirements. Main Responsibilities Serve as the lead statistician for clinical development programs and studies Oversee statistical activities in outsourced clinical trials Ensure compliance with regulatory standards in all statistical work Apply advanced study designs and statistical methods, including estimand strategies, endpoint selection, and approaches for missing data and multiplicity Work closely with teams across biometrics, clinical development, clinical operations, pharmacovigilance, medical writing, and regulatory affairs

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 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.