Associate Director of Clinical Operations

Role Overview Acadia Pharmaceuticals is hiring an Associate Director of Clinical Operations. This position is based in either Princeton, New Jersey or San Diego, California. The Associate Director will guide key phases of clinical trials, focusing on high-quality execution and adherence to regulatory requirements. What You Will Do Lead and oversee essential stages of clinical trial operations Ensure all activities meet regulatory and company standards Promote effective collaboration across multiple teams Drive project timelines to support company objectives Take a hands-on approach to managing clinical operations

Join Kyowa Kirin, a rapidly expanding global specialty pharmaceutical company dedicated to leveraging cutting-edge biotechnologies to develop innovative medicines across four critical therapeutic areas: bone and mineral disorders, intractable hematologic conditions, hematology oncology, and rare diseases. As a Japan-based organization, we strive to transform scientific advancements into life-changing treatments for patients lacking adequate therapeutic options, guiding our projects from drug discovery to development and eventual commercialization. Our North American headquarters is located in Princeton, NJ, with additional offices in California, North Carolina, and Mississauga, Ontario.Position Overview:The Associate Director of Site Budget Management will play a pivotal role in providing strategic and operational direction for designated segments of Kyowa Kirin’s global clinical study portfolio. This position serves as a vital link between study-level execution and overarching enterprise strategies, ensuring effective budget governance, robust forecasting methodologies, financial risk management, and continuous process optimization.In this role, you will ensure budget consistency, oversee negotiation parameters, and manage payment processes while contributing to both short and mid-range portfolio planning. Additionally, you will uphold financial integrity and alignment with global Fair Market Value (FMV) standards across all relevant studies.

Acadia Pharmaceuticals is seeking a dynamic and experienced Director of Clinical Research to lead and manage our clinical research initiatives. This role is critical in shaping our clinical development strategy and ensuring the successful execution of clinical trials. You will collaborate with cross-functional teams and external partners to drive innovative research that aligns with our mission to improve the lives of patients.

Join Kyowa Kirin, a rapidly expanding global specialty pharmaceutical company, committed to innovating life-changing medicines through cutting-edge biotechnologies. We focus on four key disease areas: bone and mineral disorders, intractable hematologic conditions, hematology oncology, and rare diseases. Our mission is to convert scientific advancements into therapeutic solutions, ensuring that patients receive the care they need when existing treatments fall short. Our North America headquarters is based in Princeton, NJ, with additional offices in California, North Carolina, and Mississauga, Ontario.Position Overview:The Associate Director of Clinical Quality Management acts as the primary Risk-Based Quality Management (RBQM) Lead within Clinical Operations. This pivotal role oversees proactive risk management strategies across clinical trials, implementing a comprehensive RBQM framework that encompasses risk identification, assessment, mitigation, centralized monitoring, lessons learned, and the upkeep of a clinical risk library. This ensures uniform risk management practices across studies, programs, vendors, and regions. Collaborating with various departments, this role integrates risk-based decision-making into all aspects of study design, execution, oversight, and continuous enhancement, in accordance with ICH E6 (R3), GCP, and global regulatory standards.

About Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific breakthroughs into impactful innovations that significantly improve the lives of individuals in underrepresented neurological and rare disease communities globally. Our product lineup features the first and only FDA-approved therapies for Parkinson’s disease psychosis and Rett syndrome. We are at the forefront of therapeutic advancements with a rich pipeline that includes mid- to late-stage programs targeting Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage initiatives addressing various unmet patient needs. With Acadia, we strive to make a difference.Position OverviewThe Director of Clinical Pharmacology will leverage extensive expertise in preclinical and clinical development, demonstrating a proven ability to advance drug candidates through initial development stages. This role will be pivotal in representing the Clinical Pharmacology discipline within cross-functional Asset Teams and leading early-stage programs. Key duties encompass the strategic planning and execution of Phase 1 clinical trials, including First-in-Human (FIH) and proof-of-concept (PoC) studies involving healthy volunteers. This position supports drug development across various therapeutic areas, emphasizing neuroscience. Key ResponsibilitiesAnalyze nonclinical data and translate insights into clinical pharmacology development strategies that position Acadia’s programs for successful clinical transitions.Design and supervise early-phase clinical trials (e.g., FIH, food effect, DDI studies).Collaborate with team members to select and implement suitable biomarker, imaging, and pharmacodynamic endpoints for proof-of-concept (PoC) studies in healthy volunteers.Develop and review study protocols, statistical analysis plans, and tables, listings, and figures (T...

About Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific breakthroughs into impactful innovations for communities affected by neurological and rare diseases globally. Our portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are advancing a diverse pipeline of therapeutic solutions targeting Alzheimer’s disease psychosis and Lewy body dementia psychosis, alongside earlier-stage initiatives addressing additional patient needs. At Acadia, we strive to make a difference.Position Summary:The Director of Clinical Trial Materials (CTM) plays a critical role in supporting clinical development initiatives by assisting the Senior Director of CTM in both planning and operational execution for Phase I-IV studies and IIS trials. Responsibilities include defining both short and long-term objectives for the team, forecasting demand, managing budgets, establishing production timelines, reviewing protocols, ensuring compliance with labeling requirements, collaborating cross-functionally to meet regulatory standards, devising optimal packaging and distribution strategies, and monitoring drug supply levels while tracking product retest dates. This role requires effective interaction with internal departments, Contract Research Organizations (CROs), and Contract Manufacturing Organizations (CMOs) to coordinate the successful execution of clinical trial activities. Additionally, the Director will ensure adherence to global regulations and procedures related to the production and distribution of investigational products and mentor junior members of the CTM team as needed.Primary Responsibilities:Review and interpret clinical protocols or study overviews:Provide constructive feedback during the clinical protocol development process.Assess overall demand and translate this into a demand forecast.Collaborate with Project Managers to create clinical supply timelines, gather study overviews and drug requirements, and initiate procurement processes.Regularly review and update inventories and supply plans according to clinical forecasts, ensuring all supply-related information is accurate.

About Us Kardigan is a pioneering heart health organization dedicated to transforming cardiovascular disease from a leading cause of mortality into a preventable and curable condition.Our mission is to develop multiple targeted therapies simultaneously, ensuring that individuals suffering from cardiovascular diseases receive the cures they rightfully deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders reunite after successfully guiding MyoKardia in the discovery and development of mavacamten, the first cardiac myosin inhibitor, which culminated in its acquisition by Bristol Myers Squibb in 2020. We boast an innovative discovery and translational research platform, a robust pipeline of late-stage candidates, and an exceptional team committed to enhancing patients' lives. At Kardigan, our values shape our interactions and drive us towards our goals. We are patient-centered, prioritizing the needs of patients and their families. We value authenticity, fostering an environment where everyone feels accepted. With a strong curiosity, we embrace learning and are open to evolving our perspectives. We believe in collaborative success, supporting one another to achieve excellence with urgency and purpose. Finally, we aim to enable the impossible, taking calculated risks to drive innovation and advance scientific breakthroughs. These core values empower us to make a meaningful impact every day.

Kyowa Kirin is an innovative global specialty pharmaceutical company, leveraging cutting-edge biotechnologies to discover and deliver groundbreaking therapies across four key disease areas: bone and mineral disorders, intractable hematologic conditions, hematology oncology, and rare diseases. As a company rooted in Japan, our mission is to translate scientific advancements into meaningful patient outcomes by providing effective treatments where options are limited, spanning from drug discovery to product development and market entry. Our North American headquarters is located in Princeton, NJ, with additional offices in California, North Carolina, and Mississauga, Ontario.Position Overview:The Director of Pharmacometrics will spearhead a team of skilled Pharmacometricians within the Global Development Organization (GDO) and the Clinical Pharmacology (CP) function. This role combines direct project involvement with the mentorship of team members in the design and implementation of model-informed drug development (MIDD) strategies. Responsibilities include enhancing workflows and systems for delivering quantitative clinical pharmacology outputs. The Director will play a crucial role in educating project teams and organizational leadership on the significance of MIDD and quantitative clinical pharmacology strategies. Furthermore, the Director will explore collaborative opportunities with various Kyowa Kirin departments, such as Regulatory Affairs and Medical Affairs, to proliferate MIDD strategies throughout the development process and in post-marketing efforts.Key Responsibilities:Oversee pharmacometrics deliverables for project teams, ensuring scientific integrity, timeliness, and substantial impact; identify and capitalize on opportunities to elevate quantitative clinical pharmacology within the organization.Direct pharmacometrics strategy and guarantee high-quality preparation of pharmacometric components for scientific documentation, regulatory submissions, and responses to health authority inquiries.Provide scientific and technical guidance to pharmacometrics staff, ensuring excellence in modeling techniques and effective communication across all organizational tiers.Facilitate clear and impactful communication of pharmacometric and clinical pharmacology findings to diverse internal and external stakeholders.Collaborate with GDO Clinical Pharmacology colleagues and cross-functional partners to enhance efficiency, alignment, and innovation in drug development initiatives.

Kyowa Kirin, Inc. is a dynamic and rapidly expanding global specialty pharmaceutical company dedicated to advancing biotechnological innovations to discover and deliver groundbreaking therapies across four critical therapeutic areas: bone and mineral disorders, intractable hematological conditions, hematology oncology, and rare diseases. Headquartered in Princeton, NJ, we aspire to transform scientific breakthroughs into meaningful treatments, ensuring that patients have access to therapies where current options are insufficient. Our North American presence includes additional offices in California, North Carolina, and Mississauga, Ontario. Position Overview: As the Director of Clinical Science (Non-Hemato-Oncology), you will play a pivotal role in our expanding global organization. This leadership position within the Clinical Science group involves collaborating with multi-disciplinary project teams to drive key milestones (such as IND, FIH, POC, EOP2, NDA) for various development programs. You will lead scientific discussions, providing deep insights into the clinical aspects of your assigned programs, and serve as a subject matter expert. In addition, you will actively contribute to the preparation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans for both new and existing products, while also managing lifecycle strategies. Establishing and nurturing relationships with Key Opinion Leaders (KOLs) will be essential to your success.

Ascendis Pharma is an innovative and rapidly expanding global biopharmaceutical company with offices in Denmark, Europe, and the United States. We are at the forefront of advancing treatments in Endocrinology, Rare Diseases, and Oncology.At Ascendis, we take pride in our commitment to exceptional scientific discovery, visionary leadership, and a team of dedicated and passionate professionals.Driven by our core values of Patients, Science, and Passion, we leverage our TransCon® drug development platform to fulfill our mission of creating groundbreaking therapies that address significant unmet medical needs.Our culture is designed to empower skilled, adaptable, and resourceful professionals to leave their mark, offering a vibrant workplace that encourages continuous growth and skill development.The Director of Clinical and Medical Strategic Planning plays a pivotal role in enhancing productivity and efficiency within the Endocrine & Rare Disease Medical Sciences (ERDMS) team by providing structure, visibility, and decision-making support. As part of the ERDMS leadership team, this position will lead the design and execution of clinical development plans and medical evidence generation strategies, aligning with Ascendis Pharma’s mission, values, vision, and priorities.

About UsKardigan is a pioneering heart health company dedicated to making cardiovascular diseases preventable, treatable, and ultimately eliminating them as the leading cause of death globally.Our mission at Kardigan is to develop a range of targeted therapies simultaneously, ensuring that individuals suffering from cardiovascular diseases receive the cures they rightfully deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's team has reunited after their successful journey with MyoKardia, where they discovered and developed mavacamten, the first cardiac myosin inhibitor, culminating in a significant acquisition by Bristol Myers Squibb in 2020. We boast a state-of-the-art discovery and translational research platform, a robust pipeline of late-stage candidates, and an exceptional team committed to enhancing patient outcomes. At Kardigan, our values shape our operations and interactions. Driven by the needs of patients and their families, we prioritize their welfare above all. We believe in being authentic—creating an inclusive environment where everyone feels valued. Our team is characterized by a thirst for knowledge, fostering curiosity and adaptability. We emphasize teamwork, striving for excellence and urgency in all our endeavors. Our commitment to innovation drives us to take calculated risks, unlocking new scientific advancements for the benefit of patients. These guiding principles empower us to make a tangible difference every day. Position Title: Executive Director, Clinical Data Management Department: Development Operations & Biometrics Reports To: VP, Biometrics

We are seeking a highly skilled Senior Business Analyst to join our Clinical Operations team at Integrated Resources Inc. In this pivotal role, you will leverage your analytical expertise to support clinical projects and streamline operational processes. Your insights will guide decision-making and enhance project outcomes in a fast-paced and dynamic environment.

About Acadia Pharmaceuticals Acadia Pharmaceuticals focuses on bringing scientific advances to patients affected by neurological and rare diseases. The company’s commercial portfolio includes the only FDA-approved therapies for Parkinson’s disease psychosis and Rett syndrome. Acadia continues to develop a varied pipeline, with programs in mid- to late-stage development for Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage research addressing additional unmet needs. Location and Hybrid Work This Director of Translational Science Operations position may be based in San Diego, CA; San Francisco, CA; or Princeton, NJ. Acadia’s hybrid work model requires an on-site presence in the office three days per week on average. Role Overview The Director will lead operations for Translational Sciences, supporting nonclinical, toxicology, and pharmacology/pharmacometrics clinical teams. This position manages systems that support both clinical and nonclinical activities within the Translational Science department. Responsibilities include vendor and contract oversight, due diligence on agreements, and managing budgets and timelines. Success in this role depends on effective collaboration with internal and external stakeholders to ensure timely and coordinated execution across Acadia’s programs. Key Responsibilities Oversee operational management of Translational Science project activities, working closely with functional representatives to deliver on plan and within budget.

About Us Kardigan is at the forefront of heart health innovation, aiming to transform cardiovascular disease into a preventable and curable condition, ultimately striving to eliminate it as a leading cause of death worldwide.Our mission is to develop a range of targeted treatments simultaneously, ensuring individuals with cardiovascular diseases can access the cures they rightfully deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan has reunited after their successful journey at MyoKardia, where they pioneered mavacamten, the first cardiac myosin inhibitor, culminating in its acquisition by Bristol Myers Squibb in 2020. With a state-of-the-art discovery and translational research platform and a pipeline of late-stage candidates, our exceptional team is dedicated to enhancing patient lives. At Kardigan, our values shape our work culture, guiding our interactions and driving our achievements. We are fueled by our commitment to patients and their families, placing their needs at the forefront of our efforts. We embrace authenticity, fostering an environment where every individual feels valued and accepted. Our culture encourages curiosity and the willingness to adapt, as we strive for collective success with urgency, excellence, and purpose. We are unafraid to take risks to unlock innovation and propel scientific advancements; after all, our patients depend on us. These principles are the bedrock of our daily efforts, empowering us to make a meaningful impact. Job OverviewKardigan is in search of an Associate Director of External Manufacturing to lend their expertise in managing a significant late-phase portfolio. This position will report directly to the Senior Director of External Manufacturing.

Join Acadia Pharmaceuticals as an Associate Director of Vendor and Relationship Management, where you will play a pivotal role in optimizing our partnerships and vendor strategies. This leadership position requires a vision for fostering strong relationships with our suppliers while ensuring the efficient delivery of our pharmaceuticals.Your main responsibilities will include developing and executing vendor management strategies, overseeing contract negotiations, and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to support project goals and timelines, contributing to the overall success of Acadia's mission.

About Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific potential into innovative solutions that significantly benefit underserved communities dealing with neurological and rare diseases globally. Our current commercial portfolio features the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are actively developing a diverse pipeline of therapeutic advancements, which includes mid- to late-stage programs targeting Alzheimer's disease psychosis and Lewy body dementia psychosis, alongside earlier-stage initiatives aimed at addressing various unmet patient needs. At Acadia, our mission is to make a difference in the lives of these patients.Seeking talent near: Princeton, NJPosition SummaryThe Associate Director of Drug Product Development will lead the formulation, primary packaging, and manufacturing process development for Acadia’s expanding portfolio of drug candidates across all development phases. This role involves providing technical oversight, expertise, and guidance for outsourced drug product development activities. The responsibilities encompass the development of formulations, packaging, and processes for various administration routes, including oral solid, liquid, and injectable dosage forms, managing candidates from clinical development through to process validation and lifecycle management. The successful candidate will oversee activities related to these tasks at Contract Service Providers (CSPs) and play a pivotal role in addressing complex technological challenges while implementing new manufacturing technologies for products intended for clinical and commercial distribution. This position is vital for optimizing development, mitigating risks, and expediting the launch of new assets into the market.Primary ResponsibilitiesDesign and develop pharmaceutical formulations and manufacturing processes to support clinical trials, regulatory submissions, and product launches.Evaluate and validate new drug product Contract Service Providers (CSPs) to facilitate development, scaling, and commercialization of new drug candidates within Acadia’s pipeline. Initiate and manage supplier contract agreements as necessary.

About UsKardigan is an innovative heart health company dedicated to transforming the landscape of cardiovascular disease, making it preventable and curable, and ultimately eliminating it as the leading cause of death worldwide.Our mission is to develop a range of targeted treatments simultaneously to ensure that individuals suffering from cardiovascular diseases receive the cures they truly deserve.Founded by experts Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., who previously led MyoKardia in the groundbreaking development of mavacamten—the first cardiac myosin inhibitor acquired by Bristol Myers Squibb in 2020—we have established a state-of-the-art discovery and translational research platform paired with a robust pipeline of late-stage candidates. Our team is passionately committed to enhancing patient outcomes.At Kardigan, our core values guide our operations and interactions. We are driven by patients and their families, authentically engaging with each other to foster a supportive work environment. Our eagerness to learn fosters curiosity and adaptability. We believe in winning as a team, demonstrating urgency and excellence, and supporting one another regardless of our roles. We also strive to enable the impossible, taking calculated risks to unlock innovation and promote scientific advancements.

Kyowa Kirin is a rapidly expanding global specialty pharmaceutical company leveraging advanced biotechnologies to discover and deliver groundbreaking medicines across four key disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare diseases. Headquartered in Princeton, NJ, with additional offices in California, North Carolina, and Mississauga, Ontario, our mission is to transform scientific innovation into therapeutic solutions where effective treatments are currently lacking.Position Overview:The Associate Director, ERP Functional & Solutions Architect, ICT will play a pivotal role in managing the Microsoft Dynamics 365 (D365) Enterprise Resource Planning (ERP) system within our organization. This position is essential for implementing business process enhancements and ensuring the ERP system operates at peak functionality. The role involves planning, designing, configuring, and customizing MS D365/ERP modules and functionalities, ensuring they integrate seamlessly with existing systems while adhering to industry standards, security protocols, and regulatory requirements. As a business process analyst, the Associate Director will collaborate closely with various corporate functions including Supply Chain Management, Manufacturing, Quality, Finance, Human Resources, Legal, Compliance, and Procurement to ensure the successful development and delivery of technical solutions.Key Responsibilities:The D365 ERP F&O Functional Architect will oversee the comprehensive functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations, supporting business functions across Finance, Procurement, Supply Chain, Manufacturing, and Quality. This role will involve partnering with business stakeholders, technical teams, and implementation partners to align solutions with corporate strategies, ensure compliance with applicable GxP/GAMP 5 standards, and facilitate scalable solutions for future growth.Solution Architecture & Design:Lead the functional design and architecture of the D365 F&O solution across critical modules including Finance, Supply Chain, Manufacturing, Procurement, Inventory, and Quality. Translate complex business requirements into clear, scalable, and compliant functional solutions, emphasizing proactive leadership in solution architecture aligning with business objectives.

Join Kyowa Kirin, a rapidly expanding global specialty pharmaceutical company dedicated to leveraging cutting-edge biotechnologies to uncover and deliver innovative therapies across four key disease areas: bone and mineral disorders, intractable hematologic conditions, hematology oncology, and rare diseases. Headquartered in Princeton, NJ, with additional offices located in California, North Carolina, and Mississauga, Ontario, our mission is to transform scientific advancements into meaningful patient outcomes where effective treatments are currently lacking.Position Overview:The Associate Director, Veeva Vault Architect, acts as the technical and strategic leader in designing, implementing, and refining Veeva Vault solutions across our global operations. This crucial role ensures that all Vault applications are in harmony with business goals, regulatory standards, and enterprise architecture protocols. The architect will collaborate closely with business stakeholders, IT teams, and implementation partners to deliver scalable, compliant, and high-performance Vault-based solutions.Key Responsibilities:Solution Architecture & Design• Develop comprehensive architecture for Veeva Vault applications (including Quality, RIM, Medical, Commercial).• Translate business needs into scalable, secure, and compliant Vault configurations.• Define data models, object structures, workflows, lifecycle states, and security parameters.• Establish integration methodologies between Vault and other enterprise systems (ERP, LMS, MDM, LIMS, etc.).• Create architectural standards, design documents, and technical specifications.Platform Leadership• Serve as the expert on Veeva Vault capabilities, limitations, and best practices.• Guide configuration teams on Vault objects, metadata, workflows, and automation processes.• Evaluate new Vault features and releases, advising on their adoption and impact.• Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and other regulatory frameworks.Implementation & Delivery• Lead technical workstreams during Vault implementations, migrations, and enhancements.• Oversee data migration strategies, including mapping, cleansing, and validation.• Support test planning, execution, and defect resolution for configurations.

About Acadia Pharmaceuticals At Acadia Pharmaceuticals, we are dedicated to transforming scientific breakthroughs into impactful solutions for underserved populations affected by neurological and rare diseases globally. Our portfolio features the first and only FDA-approved therapies for Parkinson’s disease psychosis and Rett syndrome. We are advancing innovative treatments through a diverse pipeline, including programs targeting Alzheimer’s disease psychosis and Lewy body dementia psychosis. At Acadia, we strive to be the difference for those in need.Please be aware that this role can be located in San Diego, CA; Princeton, NJ; or San Francisco, CA. Acadia operates under a hybrid work model, requiring in-office attendance three days per week on average. Position OverviewThe Associate Director of GLP/GCP Quality Audits and Compliance is pivotal in safeguarding data integrity and ensuring regulatory compliance across the company's nonclinical and clinical operations. This role encompasses the planning, execution, and reporting of both internal and external GLP/GCP audits, ensuring adherence to U.S. and international regulations while promoting ongoing enhancements in quality systems.As a valued quality partner, this role will provide expert advice on GLP/GCP compliance, assist in regulatory inspections, and collaborate closely with internal teams and Contract Service Providers (CSPs) to sustain inspection-ready operations. The ideal candidate will possess strong audit leadership skills, sound regulatory judgment, and the ability to positively influence quality practices throughout the organization.Key ResponsibilitiesPlan, schedule, coordinate, and conduct internal and external GLP/GCP audits of company functions and Contract Service Providers (CSPs) according to company standards and global regulatory requirements.Manage the complete audit lifecycle, including preparation, execution, documentation, reporting, follow-up, and validation of corrective and preventive actions.Prepare, review, and approve clear, compliant audit reports, ensuring that observations, risks, and responsibilities are effectively communicated to relevant stakeholders.