Senior Medical Director of Drug Safety & Pharmacovigilance

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.

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

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

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

Join Integrated Resources Inc. as a Senior Associate in Pharmacovigilance, where you will play a crucial role in ensuring drug safety and regulatory compliance. We are seeking a detail-oriented professional who is passionate about pharmacovigilance and eager to make a significant impact in the pharmaceutical industry.

Join Integrated Resources, Inc. as a Pharmacovigilance Scientist and contribute to the safety and efficacy of pharmaceutical products. In this role, you will be responsible for monitoring, assessing, and reporting adverse effects associated with drug therapies. Your expertise will directly impact patient safety and regulatory compliance while collaborating with cross-functional teams.

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

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.

Scholar Rock is a pioneering biopharmaceutical organization dedicated to the discovery, development, and provision of transformative therapies aimed at addressing significant unmet medical needs for individuals suffering from serious health conditions. As a frontrunner in understanding the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, our clinical-stage company is devoted to advancing innovative treatments that leverage the fundamental role of protein growth factors. Over the last decade, we have established a robust pipeline that aims to elevate the standard of care for conditions such as neuromuscular diseases, cardiometabolic disorders, cancer, and other illnesses where growth factor-targeted therapies can make a substantial difference. Scholar Rock is distinctively positioned as the only company to showcase clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our unwavering commitment to exploring fundamentally novel therapeutic strategies is fueled by our proprietary platform, which has successfully developed innovative monoclonal antibodies designed to modulate protein growth factors with remarkable selectivity. By applying cutting-edge scientific advancements in traditionally under-addressed disease areas, we strive daily to forge new possibilities for patients. Discover more about our approach at ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:Scholar Rock is actively seeking a highly skilled and technically adept Senior Director of Drug Product External Manufacturing to spearhead the external manufacturing of drug products across our portfolio of biologics, which includes monoclonal antibodies, fusion proteins, and bispecifics. In this pivotal role, you will lead and supervise all drug product manufacturing operations conducted through external contract manufacturing organizations (CMOs). This position is essential for ensuring the efficient production, quality assurance, and timely delivery of both clinical and commercial products, in alignment with our organizational objectives and stringent regulatory requirements. The ideal candidate will possess extensive expertise in biopharmaceutical manufacturing, demonstrate strategic leadership capabilities, and exhibit a strong aptitude for managing complex global operations.

Nuvalent is seeking a highly experienced and visionary Senior Director of Drug Metabolism and Pharmacokinetics (DMPK) to lead our DMPK team. This role is crucial for the advancement of our drug development programs as we strive to create innovative treatments. Join us in our mission to transform the lives of patients with targeted therapies.

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

Role Overview Isomorphic Labs is seeking a Director of Computational Drug Design to join its Cambridge, MA site. This leader will shape computational chemistry strategy for both internal research and collaborative projects. The position sits within the Drug Design and Medical Research division, working closely with AI and machine learning specialists to advance the company’s drug design engine and accelerate new medicine development. About Isomorphic Labs Founded in 2021, Isomorphic Labs (IsoLabs) builds on the AlphaFold system, applying advanced AI to solve complex problems in human health. The team combines drug discovery expertise with machine learning to create predictive and generative models that speed up scientific discovery. The company’s mission is to design novel molecules, predict drug performance, and develop new treatments for challenging diseases by modeling biological systems with AI. Isomorphic Labs has developed an AI-driven drug design engine capable across various therapeutic areas and drug types. The organization continues to refine model architectures and expand capabilities, aiming to realize the promise of digital biology and ultimately eradicate disease through artificial intelligence. About the Computational Drug Design Team The Cambridge-based Computational Drug Design team brings together computational chemists focused on driving strategy, supporting both internal and partner projects. Close collaboration with AI/ML colleagues is central to the group’s work, ensuring the continued evolution of the Isomorphic Labs Drug Design Engine. The team values a supportive environment, ongoing learning, and professional development for every member.

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.

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.

As a Pharmacovigilance Coordinator at Integrated Resources, Inc., you will play a critical role in ensuring the safety and efficacy of pharmaceutical products. You will be responsible for the monitoring, assessment, and reporting of adverse drug reactions, working closely with healthcare professionals and regulatory bodies.This position requires strong analytical skills, attention to detail, and a commitment to maintaining the highest standards of patient safety.

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.

Join our dynamic team at Integrated Resources, Inc. as a Clinical Safety Data Manager. In this pivotal role, you will oversee the management and analysis of clinical safety data, ensuring compliance with regulatory standards and enhancing patient safety. Your expertise will be vital in developing safety databases and implementing data management processes that support clinical trials.

Pioneering Medicines, part of Flagship Pioneering, develops a broad range of new treatments by applying advanced scientific platforms. The team combines deep drug development knowledge with creative approaches to uncover and advance new therapeutic ideas. Close collaboration with Flagship’s bioplatform companies and external partners helps align efforts with R&D priorities, aiming to move discoveries quickly toward development. Role overview The Senior Director, Head of Toxicology leads the toxicology function at Pioneering Medicines. This position sets and executes nonclinical safety strategies across a varied and fast-moving portfolio. The role covers both investigative and regulatory toxicology, supporting multiple therapeutic modalities. Key responsibilities Establish and oversee nonclinical safety strategies for a growing portfolio of drug candidates. Provide scientific and strategic guidance for investigative and regulatory toxicology activities. Collaborate with multidisciplinary teams to support candidate selection and preclinical development. Ensure programs are prepared for regulatory submissions and early clinical development. Requirements Strong analytical skills and scientific rigor. Clear, effective communication across teams and partners. Experience influencing projects from discovery through early clinical stages. This role is based in Cambridge, MA.

About Healx Healx is an innovative tech bio company harnessing the power of AI to revolutionize drug discovery. With more than 10,000 rare diseases impacting 400 million individuals worldwide, and 90% of these conditions without approved treatments, our mission is to spearhead a new era in drug development that expedites access to therapies for patients. We merge extensive data analytics, cutting-edge artificial intelligence, and deep pharmacological knowledge to create therapies with greater efficiency and cost-effectiveness compared to traditional methods. Diversity and inclusion are fundamental to our mission of supporting those with rare diseases. We believe that cultivating and empowering a diverse workforce is essential to fulfilling this vision. We warmly invite applications from individuals of all backgrounds and experiences. If you are passionate about our mission and values, we encourage you to apply, even if you don’t meet every listed requirement. Our Core Values Care for rare – Our focus is on patients at the center of all we do. Grow as individuals – We are committed to continuous learning and expertise development. Win as a team – We promote inclusivity, celebrate achievements, and learn together. Innovate and deliver – We act swiftly, embrace calculated risks, and maintain high standards. The Role We are in search of a Translational Scientist (DMPK & Safety) to play a pivotal role in translating AI-driven drug predictions into clinical outcomes. This position is drug-focused and highly collaborative, where you will generate and analyze data while shaping the non-clinical pathway to clinical application. You will be part of the pharmacology team, collaborating closely with our technology, curation, and clinical teams to convert computational predictions into promising therapeutic candidates. We seek a candidate with robust DMPK expertise who is eager to broaden their scope into a comprehensive translational role, making strategic contributions throughout the drug discovery lifecycle.