Dianthus Therapeutics jobs

Executive Director / Vice President, Corporate and Internal Communications - BioPharma Remote About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology - enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn . About the Role BioPharma Experience is required. We are seeking a strategic, creative, and execution-oriented ED / VP, Corporate & Internal Communications to build and lead a modern, high-impact communications function in a fast-growing biotech company. This role sits at the intersection of people, corporate brand, and business strategy-responsible for shaping how we communicate internally and externally, strengthening employee engagement, elevating our corporate brand, and ensuring a consistent and compelling company narrative across all audiences, while operating as predominantly a remote company. You will serve as a trusted advisor to senior leadership and partner closely with the VP of Marketing and VP of Investor Relations to ensure alignment across corporate and internal communications. We are building a culture of individuals who hold our core principles at

Senior Director, Clinical Development Remote About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology - enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn . About the Role The Senior Medical Director, Clinical Development will be the clinical and medical strategic lead of one or more clinical trials for DNTH212. Reporting to the SVP, Clinical Development, you will steer the preparation, review and execution of clinical study synopses and protocols, investigator brochures, and clinical study reports; review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide the data interpretation and data mining, and ensure assigned studies are conducted according to GCPs and SOPs. You will act as a the medical monitor in close collaboration with the CRO medical and clinical monitors, ensure timely recruitment in collaboration with clinical operations, oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data. You must have experience with Rare Diseases or Rheumatology within the biotechnology or pharmaceutical

Associate Director, Pharmacovigilance Remote About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology - enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn . About the Role As the Associate Director, Pharmacovigilance, you will work closely with the Safety team to support ongoing clinical trials. This role is critical in ensuring patient safety and regulatory compliance throughout the drug development lifecycle. Day to day, you will work closely with safety physicians, clinical teams, and external stakeholders to manage safety data and contribute to safety oversight. You must have experience reviewing adverse events, safety signals, and coordinate/contribute to the Safety Review Committee (SRC) and Drug Safety Monitoring Boards (DSMB) meetings. You must have experience supporting clinical pharmacovigilance activities and working with DSMBs in order to be successful in this role. This is a unique role that will allow you to work collaboratively with the growing pharmacovigilance team that is working closely with cross functional teams to help Dianthus elevate

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Senior Medical Director, Oncology Redwood City, California, United States For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . Responsibilities: - Design and implement Phase I to III clinical studies - Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents - Provide scientific oversight for Company operational staff, CROs, and clinical trial sites in all areas related to the therapeutic programs - Act as a clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs - Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports - Act to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee - Play a key role in the analysis, interpretation and delivery of high-quality clinical data - Interact with

Manager, Developmental Sourcing Redwood City, California, United States For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . We are seeking a dynamic and strategic professional to join our organization as a Sourcing Manager within Clinical Research & Development. In this role, you will lead the development and execution of sourcing strategies, manage a diverse supplier portfolio, and drive continuous improvement across procurement processes. You will work cross-functionally to enhance supplier performance, manage risk, and deliver cost-effective, high-quality solutions aligned with business goals. This role supports Clinical Research & Development teams by leading sourcing activities and vendor negotiations for Corcept's clinical trials. This position requires strong analytical skills, excellent communication, strategic thinking, and a proven ability to build and maintain effective supplier and stakeholder relationships. Key Responsibilities: - Develop and implement sourcing strategies to achieve procurement goals and long-term business objectives - Lead the creation and finalization of Site Clinical Trial Agreements (CTAs), CRO agreements, and Investigator

Senior/Executive Director, Health Economics & Outcomes Research (HEOR) Viking Therapeutics, Inc. Senior/Executive Director, Health Economics & Outcomes Research (HEOR)

Manager, Patient Safety & PV Compliance, Standards, and Training Redwood City, California, United States For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . The Manager, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training is responsible for supporting and managing activities for the execution and day-to-day oversight of PSPV compliance activities, including metrics/KPIs, maintenance of procedures, training programs, and quality system processes supporting both investigational and marketed products. This role partners closely with PSPV sub-functions, Quality Assurance, Clinical, Regulatory, and external vendors to ensure ongoing regulatory compliance. Key Responsibilities - Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes are implemented consistently and in alignment with regulatory requirements - Author, review, revise, and maintain PSPV procedures, work instructions, and related controlled documents in compliance with global PV regulations (FDA, EMA, ICH) - Contribute to and manage activities for the development, implementation, and maintenance of role-based PV training programs, including initial

Senior Manager, Clinical Data Management Redwood City, California, United States For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . The Sr Manager, Clinical Data Management, ensures optimized data collection, flow, and access across EDC and non-EDC data sources. Responsible for accuracy, completeness, and CDISC compliance of Corcept clinical databases. Responsibilities: - Provides input into the design of data flow across EDC and non-EDC data sources across vendor network - Manages data management service providers to ensure the quality of deliverables and that timelines are met - Develops and contributes to the design of processes enabling near-real-time data access for Corcept clinical trials - Ensure data quality of clinical database through the implementation of CDISC compliance - Reviews and critically assesses data query resolution metrics and suggests process improvement - Reviews study protocols to ensure that data collection and CRF design meet study objectives - Manages and oversees SAE and external vendor reconciliation between clinical and applicable

Associate Director, Clinical Development Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! The Associate Director, Clinical Development plays a key role in the design and execution of ongoing and new clinical development studies. This position serves as the clinical science representative on one or more U.S. and/or global clinical studies and contributes to the delivery of high‑quality clinical data to support registration and launch. The role partners cross‑functionally with Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Early Development,

Senior Director, Marketing Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key

Vice President, Commercial Manufacturing Operations Remote Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics' mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com . Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do-from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: The Vice President, Manufacturing Operations will report

Senior Director, Clinical Development Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! The Sr. Director, Clinical Development will play a key role in the design and execution of ongoing and new clinical studies and contribute to the clinical development plan for one or more programs. The position will successfully lead and/or serve as the clinical science representative on one or more clinical studies (US and/or global) to deliver high quality data for registration. The position requires the

Associate Director, Biostatistics Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! As an Associate Director, Biostatistics this person will provide statistical support for pipeline compounds' clinical development, regulatory filing, and commercialization. Reporting to Vice President, Head of Biometrics and Data Science, the successful candidate will serve as the biostatistician for assigned clinical trials to provide statistical leadership from trial design, data analysis, to results interpretation and dissemination. This role will also provide statistical support to regulatory filing

Director, Pharmacovigilance Operations and Engagement Redwood City, California, United States For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . This will serve as the PSPV lead for cross-functional activities and commercial initiatives, ensuring successful product launch and lifecycle management with patient safety integrated throughout the organization. This highly visible role will act as a strategic partner to Medical Affairs, Quality, Legal, and Commercial teams, driving operational and compliance excellence across all touchpoints. This is a hybrid role typically requiring on-site presence at least 3 days per week at company headquarters in Redwood City. Responsibilities: Cross-Functional Leadership & Collaboration: - Build strategic partnerships and alignment of patient safety objectives and deliverables with internal stakeholders (Medical Affairs, Quality, Legal, Commercial) and external vendors/partners - Establish and lead cross functional governance forum with PSPV, Medical Affairs, Quality, Legal, Commercial to review all commercial initiatives/activities for cross functional planning and execution - Act as the Safety Lead for implementation and

Associate Director, Oncology Digital and Omnichannel Marketing Remote For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . The Associate Director, Oncology Digital and Omnichannel Marketing will play a critical leadership role in shaping and executing the digital and omnichannel marketing plan for Corcept's first oncology product, Lifyorli, in platinum-resistant ovarian cancer. Reporting to the Senior Director of Oncology Marketing, this individual will be responsible for operationalizing Corcept's omnichannel engagement model, driving seamless, data-driven customer engagement across HCP and Patient audiences. This role will drive successful execution of digital and media plans for Lifyorli, collaborating closely with Marketing, Market Access, Insights & Analytics, and IT, ensuring campaigns are measurable and continuously optimized to deliver against brand objectives. This role requires a self-starter who can effectively navigate ambiguity, brings structure to complex initiatives and proactively partners cross-functionally to translate strategy into disciplined execution. Responsibilities: Omnichannel Planning & Implementation - Collaborate on the development and execution of the operational

Therapeutic Specialist Spain - Alicante posted: Posted 2 Days Ago

Senior Director & Therapeutic Area Head, Regulatory Affairs Redwood City, California, United States Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: - Provide management and leadership of one or more therapeutic areas for late-stage oncology programs. - Oversee the development of global regulatory therapeutic area and product strategies to drive product development, global registration, , and effective regulatory agency interactions. - Provide regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies. - Foster the career development of staff within the therapeutic area and contribute to departmental leadership activities. - Ensure alignment and consistency across programs within a therapeutic area based on regulatory intel, research, and competitive landscape. Primary Responsibilities: - Direct the development of global regulatory strategy from registrational studies to marketing application across one or more therapeutic areas. - Lead and mentor GRLs/Study Leads in the development of global regulatory strategies, in partnership with regional regulatory leads, including precedence, risk management and contingency planning. -

Therapeutic Mentor Bradenton, Florida posted: Posted 2 Days Ago

Therapeutic Specialist II China - Shenyang posted: Posted 24 Days Ago