Senior Director - Clinical Operations Program Leader (COPL) - Ophthalmology

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.

The Opportunity: Join Relay Therapeutics as a Senior Medical Director, where you will be pivotal in propelling our clinical pipeline from IND to proof of concept and ultimately to registration. In this role, you will partner with senior medical staff to shape clinical strategies, design clinical trials, and ensure successful execution. Collaborating across various functions including clinical project management, regulatory affairs, clinical operations, biostatistics, data management, and medical writing, you will significantly contribute as Relay Therapeutics continues to advance product candidates into clinical settings. You will provide clinical leadership to R&D teams and closely collaborate with Development leadership. We are open to remote employees

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.

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.

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).

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.

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 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.

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.

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.

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.

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

Join Alkeus Pharmaceuticals, a pioneering biopharmaceutical company dedicated to transforming the lives of patients with rare diseases. We are seeking a dynamic and visionary Medical Director to lead our clinical development activities, providing strategic direction and oversight for our innovative programs.As the Medical Director, you will collaborate with cross-functional teams, engage with key opinion leaders, and contribute to the development of cutting-edge therapies. This is an exceptional opportunity for a dedicated professional looking to make a significant impact in the field of rare diseases.

About BlueRock TherapeuticsBlueRock Therapeutics LP is a pioneering clinical-stage company focused on innovative cell therapies aimed at addressing neurological and ophthalmic disorders. Our leading investigational therapies, bemdaneprocel (BRT-DA01) for Parkinson’s disease and OpCT-001 for primary photoreceptor diseases, are at the forefront of clinical development. Established in 2016 as a collaboration between Versant Ventures and Leaps by Bayer, BlueRock embodies a culture defined by resilience, urgency in transforming healthcare, integrity in our mission, and a sense of community that emphasizes our collective purpose.Our VisionWe are harnessing advanced scientific techniques to guide the differentiation of universal pluripotent stem cells into authentic, functional cells, paving the way for allogeneic cellular therapies that can tackle a wide range of diseases. Our commitment to cellular and gene therapy is shaping the future of medicine and providing hope through new therapeutic options for countless patients.We are looking for talented individuals who thrive in a collaborative environment, embrace a dynamic workplace culture, and are dedicated to advancing innovative cellular therapies that will significantly impact patients' lives.The Director of Medical Writing will offer strategic and operational leadership across all Medical Writing initiatives to support BlueRock’s project portfolio from early development stages through to product registration.This role will be responsible for establishing and managing a cohesive Medical Writing function that produces high-quality regulatory documents in alignment with BlueRock’s global strategy, development timelines, and corporate objectives. The Director will lead an internal medical writing team, oversee vendor collaborations, and act as a key strategic partner to various departments including Regulatory Affairs, Pharmacovigilance, Clinical Development, Clinical Operations, Biometrics, Translational Science, and Technical Operations. Additionally, this role will play a crucial part in evolving capabilities such as AI-enabled medical writing, content reuse strategies, and collaborative models with Bayer teams.

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.

Company Overview Metaphore Biotechnologies, Inc. is a pioneering biotechnology firm dedicated to developing the next generation of biological therapeutics. Our mission is to revolutionize patient care by harnessing the potential of biological therapeutics through an innovative mimic-discovery platform. Position Overview We are actively looking for a Senior Director of CMC Development & External Manufacturing to spearhead the comprehensive CMC strategy and execution for our biologics programs. This role entails significant accountability for formulating drug substance and drug product processes in collaboration with external manufacturing partners (CDMOs). The successful candidate will oversee the integrated CMC plan encompassing strategy, timelines, budgets, and risk management, while partnering with key internal stakeholders to ensure a smooth transition into late-stage CMC operations, thereby supporting regulatory submissions and clinical supply requirements.

Alkeus Pharmaceuticals, Inc. is a pioneering clinical-stage biotechnology firm headquartered in Cambridge, Massachusetts, dedicated to the advancement of groundbreaking therapies aimed at addressing critical ocular diseases with significant unmet medical needs. Established in 2010, Alkeus has been diligently developing its flagship compound, gildeuretinol acetate (ALK-001), which has received designation as a breakthrough therapy and orphan drug status from the U.S. Food and Drug Administration. Gildeuretinol is currently being assessed across various clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) resulting from age-related macular degeneration (AMD), a leading cause of blindness in the United States.Position Summary:The Senior Clinical Scientist will take charge of providing scientific leadership and oversight for late-stage (Phase 3) clinical development programs focused on rare diseases in the field of ophthalmology. This role is crucial to maintaining scientific integrity, ensuring regulatory compliance, and successfully executing pivotal clinical trials necessary for global registration.As a key individual contributor, the Senior Clinical Scientist will act as a primary scientific collaborator throughout the clinical development process, closely partnering with clinical operations, biostatistics, regulatory affairs, and safety teams to translate strategic objectives into high-quality Phase 3 studies. This position is ideally suited for a seasoned professional with a proven track record in late-stage clinical development, particularly in rare diseases and/or ophthalmology.

We are seeking a dedicated and experienced Senior Clinical Study Manager to join our dynamic team in Cambridge. In this role, you will oversee the planning and execution of clinical studies, ensuring they meet regulatory standards and are completed on time and within budget. You will lead cross-functional teams and collaborate with various stakeholders to drive project success.The ideal candidate will have a proven track record in managing clinical trials, excellent communication skills, and the ability to navigate complex challenges. If you are passionate about advancing clinical research and want to make a significant impact, we encourage you to apply.

We are seeking a highly skilled and experienced Senior Clinical Operations Lead to join our dynamic team in Cambridge. As a pivotal member of our clinical operations team, you will play a critical role in overseeing the planning, execution, and management of clinical trials. Your expertise will ensure adherence to regulatory standards and best practices, while also fostering collaboration across multidisciplinary teams.Your responsibilities will include developing operational strategies, managing budgets, and ensuring timely project delivery. You will also be responsible for mentoring junior staff and facilitating training programs.