Senior Director of Clinical Pharmacology

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.

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases with significant unmet needs. Where others see obstacles, we identify opportunities, approaching them with urgency, rigorous scientific inquiry, and an unwavering dedication to the communities we serve. As a clinical-stage organization, we are currently focused on conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our commitment is fueled by our dynamic team. Our core values—be audacious, be curious, be authentic, be engaged, and be accountable—foster a culture of compassion and action. We have assembled a knowledgeable team poised to make an impact because the communities we support cannot afford delays. If you share our enthusiasm and are driven to tackle some of medicine’s most challenging issues, we invite you to explore this opportunity and apply.The Vice President of Clinical Pharmacology will lead and support the clinical pharmacology team, overseeing the strategic direction for evaluating the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity characteristics of all drug candidates in development, extending through commercialization when applicable. As the clinical pharmacology authority within the organization, you will leverage your matrixed leadership and team development skills to guide, mentor, and educate cross-functional teams. Additionally, you will have the chance to engage in diligence assessments. Reporting directly to the Senior Vice President and Head of Clinical Development, you will maintain a high profile within the leadership team, including interactions with the Chief Medical Officer. Your ability to synthesize both internal and external data will be crucial in formulating the clinical pharmacology strategy.

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 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.

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.

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.

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.

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.

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).

Join AbbVie as an Associate Scientist II specializing in In Vivo Pharmacology, where you will play a crucial role in advancing our innovative drug discovery efforts. You will be responsible for conducting in vivo studies to evaluate the efficacy and safety of therapeutic candidates, contributing to the development of groundbreaking 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

Join AbbVie as an Associate Scientist II or Scientist I in the field of In Vivo Pharmacology, where you'll contribute to cutting-edge research and development of innovative therapeutic solutions. This role offers the opportunity to work alongside a dynamic team dedicated to scientific excellence and impactful discoveries.

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.

Join Scismic, a trailblazing biotech startup in Cambridge, MA, dedicated to developing groundbreaking mRNA-modulating therapies aimed at curing a wide array of genetic disorders. Our innovative platforms are being applied to address critical challenges in neurological diseases, heart conditions, and muscular dystrophies.Position Overview: We are seeking a Research Associate (RA-I or RA-II) who possesses a creative approach, meticulous attention to detail, and a collaborative spirit to help propel our therapeutic candidates towards clinical application. This is a unique opportunity to make a significant impact on the lives of patients with serious unmet medical needs while working alongside our esteemed scientific team, including our visionary scientific co-founders. In this role, you will work closely with the in vivo pharmacology team to evaluate the effects of therapeutic lead candidates. The Research Associate will engage with animal models for rare genetic diseases, executing experiments that quantify molecular, cellular, and physiological outcomes, as well as supporting in vivo dosing studies and additional research activities within the in vivo pharmacology team. This position is ideal for a driven scientist eager to advance their knowledge in neuroscience, physiology, and gene therapy, all while contributing to the welfare of patients affected by rare diseases.

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.

We are seeking a highly skilled Senior Clinical Operations Lead to join our dynamic team at Integrated Resources Inc. In this pivotal role, you will oversee clinical operations, ensuring that all processes align with regulatory standards and best practices. Your expertise will guide the planning, execution, and management of clinical trials, fostering collaboration across multidisciplinary teams.The ideal candidate will have a strong background in clinical research and operations, with a proven track record of leading successful clinical projects. You will be instrumental in optimizing operational efficiency and driving the success of our clinical programs.

Join Iterative Health, a pioneering healthcare technology and services company dedicated to accelerating clinical research and transforming patient outcomes. With a robust network of over 70 clinical research sites across the US and Europe, we are at the forefront of advancing novel therapies in gastrointestinal (GI) and hepatology. Our mission is to enhance the success and growth of our partner sites through innovative tech-enabled services. By leveraging deep clinical trial expertise and advanced AI, we empower research teams and sponsors to broaden access to life-changing therapeutics for patients in need.Position Location: HybridAs the Senior Manager of Clinical Operations, you will play a critical role in reporting to the Director of Clinical Operations and collaborating closely with our Clinical Research and Life Science teams. Your key responsibilities will include engaging with partners such as sponsors, CROs, and key sites to drive operational alignment. You will provide strategic recommendations aimed at improving research operations, engaging with sponsors and CROs to report on study progress from site selection to closeout. You will also be responsible for optimizing study performance by assessing gaps, prioritizing service implementation, and serving as a subject matter expert.This is a vital, customer-facing role, where you will deliver clinical research best practices and thought leadership to our sites and sponsors.

Join Nuvalent, a pioneering biotechnology company, as a Senior Manager of Clinical Operations where you will lead and manage clinical trials, ensuring their timely and efficient execution. You will be responsible for overseeing the development and implementation of clinical operations strategy, fostering collaboration with cross-functional teams, and ensuring compliance with regulatory requirements. Your expertise will drive our mission to deliver innovative therapies for patients with cancer.