Associate Director of Safety Operations Portfolio

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.

We are seeking a dedicated and innovative Associate Scientist specializing in Neurology to join our dynamic team. In this role, you will contribute to cutting-edge research projects that aim to advance our understanding of neurological disorders. You will collaborate with experienced scientists and researchers, utilizing state-of-the-art technologies and methodologies.Key responsibilities include conducting experiments, analyzing data, and contributing to scientific publications. If you are passionate about neuroscience and eager to make a significant impact in the field, we would love to hear from you!

Join our dynamic team at Integrated Resources Inc. as a Senior Neurology Research Associate, where you will play a pivotal role in advancing groundbreaking research in neurology. You will collaborate with top-tier professionals, contributing to innovative projects that drive the future of neurological health.

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

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 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 Medical Information Associate II where you will play a pivotal role in providing accurate and timely medical information support. This is an excellent opportunity for entry-level professionals eager to start their career in the healthcare industry. You will be responsible for responding to inquiries, ensuring compliance with company policies, and contributing to the overall efficiency of our medical information services.

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.

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.

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.

Costello Medical is hiring an IT Administrator based in Cambridge, England. This position plays a central role in keeping the company’s IT infrastructure stable and secure, supporting the daily work of teams across the business. Key responsibilities Maintain and oversee IT systems throughout the organization Troubleshoot technical issues, including both hardware and software problems Apply solutions to improve system performance and strengthen security Role focus This role centers on supporting smooth operations by resolving IT challenges and ensuring reliable technology for colleagues. Company mission Costello Medical provides medical communications and data analysis services. The IT Administrator helps support this mission by making sure technology works efficiently and securely.

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.

The Opportunity:Relay Therapeutics is in search of an experienced and strategic regulatory leader to join our expanding regulatory team. In this pivotal role, you will define and implement groundbreaking regulatory strategies aimed at accelerating the development and approval of our innovative pipeline. As the global regulatory lead for relevant project teams, you will develop and execute comprehensive strategies for developmental programs. You will also be the primary liaison with the FDA, leading cross-functional teams to ensure successful domestic and international regulatory submissions, including IND, CTA, NDA, and MAA submissions.Your Role:Collaborate closely with regulatory, research, and development teams to design and implement innovative regulatory strategies for our dynamic programs, including both non-clinical and clinical regulatory strategies tailored to specific products.

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.

We are seeking a dynamic and experienced Associate Director of Real Estate to join our growing team at Turner Townsend. In this pivotal role, you will lead and manage real estate projects, ensuring the delivery of high-quality outcomes while maintaining client satisfaction. You will work closely with clients to understand their needs, develop strategic plans, and oversee the execution of real estate initiatives. Your expertise in project management and real estate development will be crucial in driving project 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.

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