Associate Director, Drug Product Development

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 Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific advancements into impactful innovations for the global community facing neurological disorders and rare diseases. Our approved treatments for Parkinson's disease psychosis and Rett syndrome set us apart as pioneers in the field. With a dynamic pipeline that addresses critical needs in Alzheimer's disease psychosis and Lewy body dementia psychosis, as well as ongoing early-stage programs, we strive to be the difference for those we serve.Talent sought in: Princeton, NJ; San Diego, CAPosition OverviewThe Associate Director within the Early Stage Drug Product Development team at Acadia will lead the formulation development of pharmaceutical products intended for early-phase clinical trials and preclinical studies. This role will closely collaborate with drug discovery teams to identify optimal drug candidates through comprehensive physicochemical analysis and property assessment. Focused on early development strategies, the successful candidate will ensure that formulations are primed for initial safety and efficacy evaluations. Collaboration with both internal scientists and external partners is vital to overcoming technical challenges and advancing promising compounds to clinical readiness.Additionally, the role involves managing activities at Contract Service Providers (CSPs) and contributing to the resolution of complex technological issues, ensuring the selection of viable drug candidates, mitigating risks, and accelerating the introduction of new chemical entities into Acadia's pipeline.Key Responsibilities Design and develop pharmaceutical formulations to facilitate early-stage clinical trials, incorporating rapid development options such as on-site compounding.Assess and validate new drug product CSPs (Contract Service Providers) to support...

We are seeking a highly experienced and strategic Senior Director of Drug Substance Development to lead our innovative team at Kardigan in Princeton, New Jersey. In this pivotal role, you will spearhead the development of drug substances from early-stage formulation through to commercialization, ensuring that our products meet the highest standards of quality and efficacy. The ideal candidate will possess a deep understanding of drug development processes, project management, regulatory requirements, and cross-functional collaboration. You will drive initiatives that enhance productivity and foster a culture of scientific excellence, providing mentorship and guidance to team members.

About Us Kardigan is a pioneering company dedicated to revolutionizing heart health by making cardiovascular diseases preventable and curable. Our mission is to develop a portfolio of targeted therapies that will provide effective treatments for individuals suffering from cardiovascular conditions. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan emerged from their success with MyoKardia, where they played key roles in the discovery and development of mavacamten, the first cardiac myosin inhibitor, leading to 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 core values shape every aspect of our work and interactions. We are driven by patients and their families, prioritizing their needs above all. We uphold a principle of authenticity, fostering an environment where everyone feels valued and accepted. Our curiosity fuels our eagerness to learn and adapt, while we emphasize team success through collaboration, urgency, and excellence. We dare to enable the impossible, taking calculated risks to drive innovation and scientific breakthroughs for the benefit of patients. These values empower us to make meaningful contributions every day. Position Title: Associate Director, Drug Substance Development Department: Technical Operations - Drug SubstanceReports To: Vice President, Head of Drug SubstanceLocation: Princeton, NJ...

Acadia Pharmaceuticals is hiring a Director of Drug Safety & Pharmacovigilance to join the team in Princeton, New Jersey. This leadership role holds responsibility for guiding the pharmacovigilance group and ensuring the safety and efficacy of Acadia's drug products. What you will do Lead and mentor the drug safety and pharmacovigilance team, providing direction and support. Oversee all pharmacovigilance activities across Acadia's portfolio, maintaining high standards for safety monitoring and reporting. Collaborate with colleagues in other departments to ensure compliance with regulatory requirements. Maintain drug safety processes that prioritize patient safety while supporting business objectives. Location This role is based onsite in Princeton, New Jersey, United States.

Join our dynamic team as a Drug Supply Manager where you will play a crucial role in managing the supply chain of pharmaceutical products. In this position, you will be responsible for ensuring the timely delivery and distribution of medications, maintaining inventory levels, and collaborating with various departments to optimize supply chain operations. If you are passionate about improving patient care and have a strong background in supply chain management, we want to hear from you!

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 is an innovative and rapidly expanding global specialty pharmaceutical company that leverages cutting-edge biotechnologies to discover and deliver groundbreaking medicines across four key therapeutic areas: bone and mineral, intractable hematologic conditions, hematology oncology, and rare diseases. Headquartered in Princeton, New Jersey, we pride ourselves on our mission to transform scientific advancements into impactful therapies, particularly in areas where treatment options are limited. Our North American operations extend across various locations, including California, North Carolina, and Mississauga, Ontario.Position Overview:The Senior Director of GRA Development & Product Strategy Team Lead will spearhead the formulation and execution of regulatory strategies while leading a talented team and overseeing global projects. This pivotal role includes managing a team of Global Regulatory Leads (GRLs) and may involve acting as a Regional Regulatory Lead (RRL) as dictated by business needs.Key Responsibilities:Develop and implement comprehensive global regulatory strategies for all products within the designated disease area, ensuring alignment with corporate objectives and maximizing the value of products.Lead and cultivate a high-performing team of Global Regulatory Leads (GRLs), providing direction and building capabilities to foster an accountable culture.Integrate regulatory strategies into global product development and lifecycle plans in close collaboration with cross-functional partners.Ensure the successful execution of regulatory strategies, encompassing global submissions, approvals, and post-approval activities for assigned products and projects.Represent the organization in engagements with health authorities, leading negotiations and overseeing agency meeting strategies.Oversee and approve global regulatory submission plans, including marketing applications and key lifecycle deliverables.Coordinate regulatory activities, timelines, and deliverables across internal teams and external partners to ensure timely execution.Maintain compliance with global regulatory requirements and internal policies, supporting inspections and audits.Monitor and communicate regulatory risks, emerging trends, and competitive intelligence, recommending mitigation strategies as necessary.Drive operational excellence by leading process improvements and standardization efforts.

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.

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

Integrated Resources, Inc. is seeking a dynamic and experienced Director of Business Development to spearhead our growth initiatives. In this pivotal role, you will be responsible for identifying new business opportunities, forging strategic partnerships, and driving revenue growth in line with our corporate objectives. Your leadership will be essential in expanding our market presence and ensuring the successful execution of our business strategies.

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.

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.

About Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific innovation into impactful solutions for underserved communities affected by neurological and rare diseases across the globe. Our commercial portfolio features the pioneering and sole FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. We are advancing the next generation of therapeutic breakthroughs with a robust pipeline that spans mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, alongside early-stage initiatives targeting other critical patient needs. At Acadia, we are committed to making a difference.This position is available in either San Diego, CA, or Princeton, NJ. Acadia operates on a hybrid model, requiring this role to be in the office an average of three days per week.

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.

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.

Join our dynamic team as a Product Event Demonstrator in Princeton, NJ! In this engaging role, you will showcase and promote a variety of products at events, engaging with customers and providing them with valuable information. Your ability to connect with people and communicate effectively will be essential in driving product awareness and sales.

About Acadia Pharmaceuticals Acadia Pharmaceuticals focuses on turning scientific discoveries into meaningful treatments for underserved communities affected by neurological and rare diseases. The company’s commercial portfolio includes the first and only FDA-approved therapies for Parkinson’s disease psychosis and Rett syndrome. Acadia continues to advance a diverse pipeline, with mid- and late-stage programs for Alzheimer’s disease psychosis and Lewy body dementia psychosis, as well as early-stage efforts aimed at additional unmet needs. The team is committed to making a real difference in patients’ lives. Location and Work Model This position may be based in San Diego, CA, San Francisco, CA, or Princeton, NJ. Acadia offers a hybrid work model. Role Overview The Executive Director of Translational Sciences leads the design and execution of disease and drug mechanism of action (MoA) studies that advance therapeutics through clinical development. This position requires deep expertise in translational sciences and hands-on experience in rare diseases. Strong leadership and mentoring skills are essential, as well as a thorough understanding of clinical biomarker development and the full drug development process from discovery through late-stage clinical trials. Success in this role depends on the ability to translate complex biological concepts and data into clear, actionable insights. The Executive Director must also demonstrate a record of effective cross-functional collaboration throughout the drug development process.