Seeking talent neat: Princeton, NJ ; San Diego, CA

Position Summary:

In support of clinical development programs, the Director of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.  Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required. 

Primary Responsibilities:

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Calculate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Proposes and implements improvements to assure efficient clinical supply operations.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
• Coordinates CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information.  Maintains departmental reports and files, updates SOPs and other projects as assigned

Education/Experience/Skills

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 4-6 years of experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Proven project management skills
• Ability to handle multiple projects simultaneously
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding of IRT system build-up and user testing
• Good negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Good organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #NC1

Please note that this position can be based in San Diego, CA OR Princeton, NJ OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Senior Manager, Quality Audits is responsible for leading and executing internal and external audits across Acadia’s expanding portfolio. This role plays a critical part in ensuring compliance with GMP and GxP regulations, maintaining robust Quality Agreements, and supporting the ongoing effectiveness and continuous improvement of Acadia’s Quality Management System. The position serves as a subject matter expert for audit readiness, regulatory compliance, and quality system optimization across clinical and commercial operations. 

Primary Responsibilities

• Plan, coordinate, schedule, and conduct internal and external GMP/GxP compliance audits, ensuring CSPs meet Acadia standards and all applicable FDA, EU (EudraLex), Canadian, and international regulatory requirements
• Prepare, review, issue, and track audit reports and observations to closure; compile, analyze, and present audit metrics and trends to support management review
• Develop, review, negotiate, and maintain quality agreements with clinical and commercial CSPs
• Maintain and continuously improve the internal audit program, including coordination of GxP audit activities with internal and external stakeholders
• Prepare, review, format, and maintain SOPs, and recommend or implement policy and procedural changes that may impact departmental or company-wide operations
• Provide GMP compliance expertise and advisory support, including support for annual product reviews, mock recalls, field alerts, and actual recall events
• Support the selection, implementation, validation, and continuous improvement of quality system–related computerized systems, including CSV support as needed
• Lead and support continuous improvement initiatives aligned with GMP and industry best practices, while ensuring compliance with company policies, including Privacy/HIPAA and other legal requirements
• Other duties as assigned

Education and Experience

• Bachelor’s degree in a Life Sciences or related field.  An equivalent combination of education and applicable job experience may be considered.
• Targeting 6 years of progressively responsible experience within quality assurance (QA), including 3 years directly responsible for GMP QA, with knowledge of external and internal auditing.
• Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
• American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus.

Key Skills:

• In-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industry
• Demonstrated expertise in QA activities and GMP regulations (FDA, EU, ICH) across clinical development, manufacturing, technology transfer, and commercial operations
• Strong ability to interpret and apply U.S. and international cGMP requirements
• Proven experience conducting internal audits, supplier audits, and manufacturing site inspections
• Ability to translate quality standards into practical implementation and review activities
• Clear, effective communicator with experience presenting technical and compliance-related information to cross-functional audiences
• Strong collaboration skills with the ability to influence and gain cooperation across functions
• Willingness to travel domestically and internationally (approximately 25–30%)

Scope

Manages department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems.  Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. It will require a focus on issues of moderate to diverse scope which will require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-Hybrid #LI-SL1

Incentive Trips:

• Help project manage annual incentive trip calendar, timelines, and budgets; track expenses, and reconcile upon program completion
• Support research and recommendations for extraordinary destinations and venues
• Plan and execute memorable on-the-ground experiences for attendees, including group meals, outings, and activities
• Brainstorm and source attendee gifts and gifting experiences
• Oversee attendee travel arrangements to ensure a VIP experience
• Provide on-site support to ensure an optimal attendee experience
• Track winner awards and rewards; report relevant information to Acadia Finance to ensure compliance with internal policies and procedures

Congresses & Conferences:

• Provide occasional on-the-ground support for medical congresses and conferences in support of Acadia’s congress-planning leads

Education/Experience/Skills:

Bachelor’s degree or an equivalent combination of relevant education and applicable job experience. A minimum of 5+ years’ experience in the pharmaceutical or biotechnology industries in progressively responsible meeting planning positions, including meetings, congresses, and incentive trips.

Must possess:

• Certified Meeting Professional (CMP) designation
• Cvent certification or comparable experience with Cvent Event Management, Attendee Hub, and Venue Sourcing modules
• Experience independently managing pre to post-event requirements for internal meetings of 30 – 50 attendees; Experience supporting meeting planning for internal meetings of 250+ attendees
• Strong written and verbal communication skills
• MS Office proficiency in Copilot, Outlook, Word, PowerPoint and Excel
• Understanding of Regulatory, Legal and Medical requirements for pharmaceutical marketing/events
• Effective interpersonal skills and the ability to lead without authority
• Strong organizational abilities and detail orientation
• Ability to prioritize effectively to manage multiple programs at one time
• Excellent budget management skills
• Experience negotiating hotel contracts
• Self-direction and a sense of urgency
• Flexibility, adaptability, and solution-orientation; able to pivot without skipping a beat
• Ability to thrive in an environment of growth and continual improvement

#LI-HYBRID #LI-CA1

Please note that this position can be based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

Primary Responsibilities

• Design, develop, validate, and deploy machine learning, statistical, and GenAI solutions that address complex business problems and support enterprise priorities
• Contribute to execution of the enterprise AI strategy and roadmap by providing technical input on use‑case feasibility, value hypotheses, architecture decisions, and build‑vs‑buy assessments
• Build and maintain scalable ML and LLM pipelines from data ingestion through production, adhering to established ML Ops and LLM Ops standards including versioning, evaluation, observability, and rollback
• Partner with business, analytics, IT, and security teams to identify, prototype, and deliver high‑value AI use cases across the organization
• Evaluate and integrate AI and GenAI platform components such as model endpoints, vector databases, agent frameworks, and guardrails in alignment with enterprise architecture standards
• Contribute to AI governance by supporting model documentation, lineage, risk assessment, bias testing, explainability, and compliance with applicable regulations and frameworks
• Provide technical input into AI platform and vendor evaluations, including RFI/RFP activities and assessments of cost, security, and data residency
• Support AI enablement efforts through development of reusable patterns, reference implementations, and technical documentation to accelerate adoption
• Apply and uphold policies for AI lifecycle management, bias/robustness testing, explainability, human oversight, and incident response. Support mapping of AI controls to major frameworks and regulations (e.g., NIST AI RMF, EU AI Act readiness) to ensure responsible and compliant AI deployment.
• Ensure all data science work complies with global AI regulations, ethical standards, and applicable GxP processes.
• Participate in cross-functional AI Governance Council activities as requested, providing technical expertise on model risk and data science practices.
• Other duties as assigned

Education/Experience/Skills

• Master’s degree or PhD in Data Science, Statistics, Computer Science, Mathematics, or a related quantitative discipline, or equivalent practical experience
• 5+ years of hands‑on experience in applied data science and machine learning, including model development, deployment, and production support
• Advanced proficiency in Python and common ML frameworks and tools such as scikit‑learn, TensorFlow, PyTorch, and SQL
• Practical experience with ML Ops and LLM Ops practices including model registries, version control, evaluation benchmarks, and monitoring
• Experience working with large language models, GenAI technologies, vector databases, or agent frameworks
• Experience operating in a regulated environment and following GxP or similar compliance processes
• Willingness and ability to travel domestically and internationally

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID

#LI-CS1

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Senior Manager R&D Learning & Development supports the development, implementation, and ongoing management of onboarding, training strategies, systems training, and learning processes that build scientific, operational, and future‑ready capabilities across the Research and Development organization and pipeline.

Primary Responsibilities

• Assist in the design, implementation, and continuous improvement of a tiered onboarding and capability-building curriculum aligned to the evolving needs of the R&D pipeline, including discovery, early development, and late-stage programs.

• Utilize experiential learning best practices to effectively engage adult learners and ensure the successful transfer of knowledge.

• Support the management of GxP, congress, and data training with internal stakeholders.

• Collaborate cross-functionally with R&D subject matter experts to develop disease area, modality, platform, and pipeline-focused training, including investigational asset education and emerging science.

• Lead and support training initiatives with internal stakeholders.

• Facilitate the management and development of learning modules in partnership with external vendors.

• Oversee the development of advanced, recurrent, and future-focused training programs, including non-technical skills critical to R&D success (e.g., scientific storytelling, data interpretation, matrix leadership, and decision-making).

• Ensure all content and training are in compliance with internal policies and external regulations.

• Lead cross-functional collaboration to enable systems and digital capability development that support scalable, data-driven learning across the R&D organization.

• Other responsibilities as assigned.

Education/Experience/Skills

Masters’ degree in Life Sciences or a related field; Advanced science degree strongly preferred (PharmD, PhD, MD).  Targeting 7 years of progressively responsible experience in psychiatry, neurology, or rare disease preferably in a pharmaceutical or biotech environment.  Psychiatry, neurology, or rare disease experience strongly desired. Must have education or training experience, including design, delivery, and evaluation of learning programs.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Knowledge of scientific, clinical and/or therapeutic area is preferred.

• Skilled and knowledgeable presenter, able to communicate complex scientific information clearly and effectively.

• Excellent oral and writing skills.

• Proficient computer skills in Microsoft Word, Excel and Outlook.

• Experience working with external vendors.

• Highly detail oriented, self-disciplined, and ability to work independently with limited direction to resolve discrepancies and issues.

• Ability to take initiative and demonstrate follow through skills.

• Excellent planning and organizational skills.

• Effective interpersonal skills to collaborate effectively in a matrix organizational structure, and with all levels within the organization.

• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.

• Must be willing and able to travel both domestically and internationally.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #NC1

Position Summary

The Sr. Director will support R&D teams through the management of reporting and analytics, workforce and budget planning and oversight, and driving strategic and transformational projects.  S/he will assist with the creation and implementation of policies and procedures.  This role will serve as a key resource across all therapeutic areas and research phases and will be required to work closely with R&D teams and vendors. 

Primary Responsibilities

Reporting and Analytics

• Oversee and manage the Acadia Clinical Command Center, including implementation, oversight, continuous improvement, and change management.
• Develop mechanisms and reports to drive data quality.
• Support data governance activities in support of the Clinical Command Center.
• Primary interface with vendor counterparts around data and to support reporting.
• Partner with cross-functional teams and external vendors to integrate data sources into the Clinical Data Warehouse.
• Oversee and drive high levels of data quality across R&D.
• Implement operational KPIs and establish governance with the purpose of driving improvements in operational efficiency.
• Develop dashboards and reports appropriate to multiple layers of functional leadership to support analysis and drive decisions.
• Point of contact for ad hoc analyses to support business questions.

Workforce Planning and Management

• Develop resource demand algorithms for R&D functions and roles.
• Establish and maintain workforce data for both internal and external staff (e.g. headcount, Functional Service Providers, contractors).
• Lead resource algorithm governance committee.
• Lead R&D workforce management through the regular review of resources, risks, issues and opportunities with key stakeholders.
• Generate and maintain access to workforce forecast data.
• Drive, in partnership with P&P, reporting around R&D headcount resources.
• Support strategic planning and portfolio decision-making through workforce modeling.

Leadership and Change Management

• Lead transformational projects across the R&D organization, as assigned.
• Lead process changes, stakeholder readiness and communication strategy as required.
• Support Business Development integration activities, as needed.
• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in a life science or a related field.  Targeting 12 years of progressively responsible experience in R&D Operations, preferably in a pharmaceutical or biotech environment.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced skills in data transformation and visualization techniques and tools (e.g. Excel, PowerBI, Tableau, Alteryx).
• Advanced skills in managing a broad-scope of multiple priorities & projects and work cross-functionally in a fast-paced environment..
• Excellent communication skills (both written and verbal), including experience in preparing/presenting key information to senior leadership.
• Ability to think and plan strategically.
• Strong analytical skills with the ability to understand scientific and financial data, recognize key issues and establish priorities.
• Committed to continuous improvement and consistently delivering measurable results
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively
• High degree of customer focus.
• Mentor and develop team members, fostering a culture of continuous improvement.
• Requires problem-solving abilities at both strategic and operational levels.
• Must be willing and able to travel both domestically and internationally.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #NC1

Please note that this position can be based in San Diego, CA, Princeton, NJ or San Francisco, CA. Acadia's hybrid model requires this role to work in our office on average three days per week.

Position Summary

Primary Responsibilities

• Develop materials to support GAP internal communications and external advocacy programs.  These may include internal newsletters, intranet content, program updates, talking points, slide decks; and external advocacy materials such as draft letters, emails, infographics and other collateral for use in advocacy programs
• At the direction of the Director of State Government Affairs, build strong and productive relationships with relevant state and local elected officials, community-based organizations, and civic partners to elevate Acadia’s visibility and drive successful outcomes for policy priorities
• Monitor state legislative and regulatory developments and provide timely analysis and updates to internal stakeholders
• Represent Acadia in relevant state and local trade associations and coalitions (e.g., BIOCOM, California Life Sciences Association, BioNJ)
• Partner with internal functions to develop briefing materials, policy positions, and presentations tailored to state and federal stakeholders
• Support the entire GAP team and work closely with our internal partners on the AIR, Commercial, Communications, Medical, R&D, Regulatory teams and others as directed
• Other duties as assigned.

Education/Experience/Skills

• Bachelor’s or Master’s degree in a relevant field such as health care administration or public policy, or equivalent relevant experience, with 5+ years of experience in health care policy and a strong understanding of today’s complex health care policy landscape.
• Proven ability to communicate effectively in both verbal and written formats
• Experience anticipating public policy trends in the health care sector
• Strong understanding of the current political environment and of policy-making processes at the state and federal level, including both legislative and regulatory processes
• Experience working across multiple functions within an organization to advance team- and enterprise-level goals
• Demonstrated ability to work collaborative and achieve consensus across a matrix environment
• Capable of managing multiple projects simultaneously with precise attention to detail, quality, and timelines.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID

#LI-CS1

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary:

Primary Responsibilities:

Data Analytics & Reporting

• Lead and mature the organization’s healthcare compliance data analytics and monitoring program, ensuring scalability, sustainability, and alignment with regulatory expectations.
• Design, develop, and maintain dashboards and analytical reporting using tools such as, Power BI and Excel to identify trends, anomalies, and compliance risk areas.
• Analyze data from key compliance systems and sources (e.g., expense reporting, HCP interactions, samples activity, state filings, and field monitoring) to support proactive risk detection and remediation.
• Partner with Compliance, Legal, Finance, and Commercial stakeholders to translate analytical insights into clear, actionable recommendations for leadership.
• Leverage analytics to support investigations and root‑cause analysis, including pattern identification, scoping, and validation of investigative findings.
• Continuously enhance data‑driven monitoring methodologies, helping to internalize analytics capabilities and strengthen overall compliance risk prioritization and training efforts.

Auditing & Monitoring

• Develop and execute the annual healthcare compliance and privacy audit and monitoring plan (U.S. and Global).
• Maintain and update monitoring documentation, workpapers, audit tools, remediation plans, and reporting templates.
• Collaborate with stakeholders across Legal, Medical, Commercial, and Finance to gather relevant data, validate findings, and drive remediation.
• Track, trend, and escalate monitoring results and areas of concern to leadership in a timely manner.
• Utilize company data sources such as email, Teams, Concur expenses, medical inquiries, samples inventory, Veeva, Elevator, and other relevant platforms.
• Apply relevant standards and regulations, including Code of Conduct, Compliance Roadmap, Employee Handbook, travel and expense SOP, internal policies, and applicable healthcare compliance and data privacy laws.

Investigations Support

• Support intake, triage, and documentation of compliance and employee relations concerns received through monitoring activities, hotline, or other reporting channels.
• Assist in fact-finding, document review, interview coordination, and root cause analysis during internal investigations.
• Maintain investigation logs, outcome documentation, and remediation tracking consistent with company policies and legal requirements.
• Ensure confidentiality, accuracy, and consistency in all investigative processes and outcomes.

Qualifications:

• Bachelor’s degree in business, compliance, healthcare, law, or related field.
• 5+ years of experience in compliance, auditing, monitoring, or investigations within the pharmaceutical, biotech, or healthcare industry.
• Strong understanding of healthcare compliance laws and regulations (e.g., Anti-Kickback Statute, False Claims Act, GDPR, HIPAA).
• Experience working with monitoring and audit tools, systems, and data sources (Concur, Veeva, expense reporting, etc.).
• Excellent analytical, organizational, and communication skills.
• Ability to handle sensitive information with discretion and maintain strict confidentiality.
• Experience in both U.S. and ex-U.S. regulatory environments.
• Background in data analytics or forensics applied to compliance monitoring.
• Prior experience supporting or leading investigations in a corporate setting.

Competencies:

• Analytical Mindset: Ability to interpret data, identify trends, and assess risk.
• Collaboration: Works effectively with cross-functional teams and external partners.
• Ethical Judgment: Applies integrity and fairness in decision-making.
• Communication: Clear and concise reporting to senior leadership.
• Adaptability: Able to navigate changing regulatory landscapes and business priorities.

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID 

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Executive Director will lead the design and implementation of disease and drug mechanism of action (MoA) studies to advance therapeutics into and through clinical development. The position requires deep experience in translational sciences, proven leadership and mentoring skills, hands-on rare disease experience, strong understanding of clinical biomarker development, and a deep understanding of drug development from discovery through late-stage clinical studies.  The ability to synthesize complex biological concepts and data into clearly communicated actionable insights is critical, as is a track record of successful partnering with functions across the drug development paradigm. 

Primary Responsibilities

• Develop translational biology strategies to interrogate disease and drug MoA, implement and drive execution for candidate targets and therapeutics

• Lead nonclinical sciences function, mentor scientists across translational sciences

• Partners with colleagues across the drug development paradigm to develop and test hypotheses designed to advance target and candidate molecule evaluation through various stages of development

• Partner with Translational Science colleagues to develop preclinical strategies supporting indication selection, PK/PD analyses, and mechanistic development for successful IND filing and clinical development

• Synthesize, analyze and integrate complex biological data, providing clear and actionable insights to drive drug development decisions

• Identify, evaluate and leverage cutting-edge technologies to expedite early-stage program development & success

• Identify and manage CROs and build strong collaborative relationships with Acadia partners to maximize the application of complementary areas of expertise

• Present programs and data for asset team, governance and senior / executive management review

• Contribute, as author and strategist, to document generation for preclinical studies & clinical protocols, clinical study reports, statistical analysis plans, research partnerships, regulatory materials (IB, IND, NDA, etc.) and publications

• Perform other responsibilities as assigned

Education/Experience/Skills

PhD in life science or related field.  Targeting 15 years of progressively responsible experience in drug development within the pharmaceutical or biotech industry.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong cross-functional leadership with a proven ability to build collaborative, high-performing teams and represent nonclinical sciences across Translational Sciences and program teams
  
  
• Hands-on experience across drug discovery, preclinical development, and clinical-stage programs (Phase 1–3), including rare disease
  
  
• Demonstrated success leading programs through IND filing, with deep expertise in small molecule INDs and regulatory submissions (IND, NDA, BLA)
  
  
• Expertise in preclinical  (MoA) analysis, indication selection, and supporting clinical development strategies
  
  
• Strong understanding of clinical biomarker strategy and development
  
  
• Ability to analyze complex, multifactorial datasets, with computational literacy and collaboration with computational biology; bioinformatics integration experience is a plus
  
  
• Effective communicator with high emotional intelligence; skilled in presenting complex data to senior leadership and influencing stakeholders
  
  
• Proven ability to make decisions under uncertainty, aligning with timelines and organizational objectives
  
  
• Track record of driving performance through goal-setting, accountability, continuous improvement, and leading change across teams
  
  
• Able to manage multiple priorities in fast-paced environments, with flexibility for domestic and international travel; experience in neurology and across modalities (e.g., ASO, mRNA) is a plus

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

LI #SL-1

Please note that this position can be based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Senior Manager, Field Force Effectiveness, will support Acadia’s commercial field teams within the Neuroscience franchise with strategic insights and data-driven recommendations. This role is critical in helping sales leadership to drive performance, identify opportunities within local geographies and support deployment strategies, including targeting, alignment and call-plan. This individual will collaborate closely with Sales, Marketing, Patient Support Services, and other cross-functional teams to help shape commercial decisions.The ideal candidate combines strong analytical capabilities with deep commercial understanding and the ability to influence cross-functional stakeholders in a highly regulated environment.

Primary Responsibilities

• Analyze sales performance, promotional effectiveness, and sub-national market trends to inform commercial sales leadership on strategy, tactics, and business planning activities
• Optimize targeting & segmentation (HCPs, IDNs, accounts)
• Align field activity with brand strategy and lifecycle priorities
• Evaluate and refine reach/frequency and HCP engagement models
• Provide insights on territory performance, sales force effectiveness, and targeting optimization to support field force initiatives
• Collaborate across functions on strategic Omnichannel Campaigns and/or triggers, working closely with Field, Marketing, IT and Advanced Analytics
• Work with large datasets (e.g., internal HUB/SP, IQVIA, claims data, etc.) to develop & enhance dashboards, KPIs, business reports, presentations and run ad-hoc analysis
• Collaborate with field leadership on the administration and execution of sales force deployment activities including processing territory alignments, targeting, and call-planning efforts
• Support Brand Planning and Business Reviews, by partnering with field leadership and Neuroscience Brand teams
• Conduct pre/post analysis of field initiatives, field activities, and local market dynamics to assess impact and ROI
• Maintain data integrity and ensure alignment with compliance and regulatory standards
• Implement advanced analytics (predictive modeling, next-best-action)
• Translate data into clear, actionable insights for leadership and reps
• Perform other duties as assigned

Education/Experience/Skills

Bachelor’s degree in Data Science, Business, Economics, Statistics, Life Sciences or related field. Targeting 6+ years of progressively responsible experience in analytics or business insights within the pharmaceutical or biotech industry. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong analytical skills with experience working with pharmaceutical data sets (e.g., internal HUB/SP, IQVIA XPT/DDD, Longitudinal claims data, CRM)
• Advance Proficiency in Excel, SQL, and BI tools such as Power BI, Tableau
• Working knowledge of sales operations, field force structure, marketing operations and/or commercial models in pharmaceuticals
• Strong communication with the ability to translate data into actionable business insights
• Experience collaborating cross-functionally with Sales, Marketing, Market Access, and Patient Services
• Strong project management and organizational skills
• Experience with CRM and analytics tools (e.g., Veeva CRM, BI tools)
• Experience in specialty or rare disease pharmaceutical markets is strongly desired
• Knowledge of data privacy regulations and compliance in healthcare analytics
• Must be able to travel domestically on occasion

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-CA1

Please note that this position can be based in either Princeton, NJ, San Diego, CA, or South San Francisco, CA. Acadia's hybrid model requires this role to work in our office an average of 3 days per week.

Position Summary

This position serves a role in the organization as the asset leader in support of the cross-functional strategy for programs (assets) in Acadia’s portfolio. This role contributes to the creation of the asset’s strategies, collaborating with the commercial, R&D, and G&A organizations to successfully deliver on asset objectives and goals. This role is accountable for the development and execution of program plans, including leading the Asset Strategy Teams (ASTs), ensuring effective communication across the wider cross-functional organization and translating decisions into action.

Primary Responsibilities

• Lead ASTs by developing, articulating, and delivering on an integrated asset strategy.
• Drive planning for key drug development stage-gate decision points, for approval at Portfolio Governance.
• Proactively conduct risk management, and contingency and scenario planning across disciplines, ensure transparent communication of risks and escalate to executive management with appropriate speed.
• Drive decision analysis with the team including development and assessment of outcome scenarios with alternative development options, robust go/no go decision criteria, probability of technical and regulatory success (PTRS), and value and investment implications.
• Ensure a coordinated approach across Portfolio Management to ensure aligned execution and consistent reporting across stakeholders (i.e., financial planning and analytics, governances).
• Manage an integrated program budget and resource plan in partnership with Finance team member and functional line representatives and sub-teams.
• Coordinate formation of the ASTs for early-stage development programs following a stage gate decision to move into IND-enabling studies or later stages through in licensing or acquisition.
• Facilitate resource planning, including financial and capacity assessments for assigned assets.
• Establish or update Target Product Profiles (TPPs) through ASTs.
• Collaborate with Sub-Teams to ensure development team plans and timelines align with asset objectives and goals.
• Other duties as assigned.

Education/Experience/Skills

• Bachelor’s degree in life science or related field; Advanced degree preferred. Targeting 12 years of progressively responsible, relevant experience focusing on program management with 8 years experience managing cross-functional project teams. Successful candidate will have a strong understanding of the drug development process from preclinical pharmacology through to regulatory approval and the principles, concepts, practices, and standards of pharmaceutical program management. An equivalent combination of relevant education and experience may be considered. 

Key Skills:

• Executive presence and communication skills required.
• Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality and risk management to teams.
• Advanced meeting facilitation skills and ability to lead cross-functional teams that include executive and senior management without direct authority.
• Financial management knowledge required.
• Excellent interpersonal, organizational, written and verbal communication skills.
• Independent, motivated, team leader with the ability to thrive in a matrix environment.
• Ability to support multiple asset teams simultaneously with strong organizational and time management skills and attention to detail.
• Ability to accommodate and lead teams through shifting priorities, demands and timelines.
• Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.· Adept at creating and communicating a clear vision for a program among team members to facilitate alignment of resources to achieve program and corporate goals.
•  Proven track record of implementing Project Management tools, methodologies, practices and infrastructure, as related to the biopharmaceutical Industry.
•  In-depth knowledge and skill with Microsoft (MS) suite including MS PowerPoint, MS Project, MS Word, MS Excel.
•  Must be able to travel domestically on occasions.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-CA1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director will lead Translational Sciences operations to support nonclinical, toxicology, and pharmacology/pharmacometrics clinical functions.  The role will own and manage systems to facilitate clinical and nonclinical activities within the Translational Science department including internal and external vendor and contract management, oversight and due diligence of agreements, management and oversight of budgets and timelines. Interfacing with internal and external stakeholders is central to the role to ensure smooth and timely operational execution across Acadia programs.

Primary Responsibilities

• Oversees the operational management of Translational Science project activities, partnering with functional representatives to ensure delivery to plan and budget and in accordance to Program Team plans/commitments

• Provides Translational Science team cross-functional project support to ensure seamless progress of activities across programs and with adjacent functions (CMC, Clinical Development)

• Identifies and manages vendors and consultants needed to complete Translational Science studies, including associated contracts and budgets. Key partner for Finance, Legal, Vendor Management and Project Management Functions

• Provides guidance to team members to objectively assess and resolve operational project issues to improve project effectiveness

• Owner of operational Translational Science group meetings to ensure budgetary compliance across programs and co-ordination with CMC to ensure compound supply is met for seamless program progression

• Partners with Head of Translational Sciences to maximize group efficiency and coordination, anticipating potential hurdles and developing mitigation strategies

• Other responsibilities as assigned

Education/Experience/Skills

Bachelor’s degree in life sciences or a related field.  Targeting 10 years of progressively responsible experience in project operations and/or project management, preferably supporting early‑stage drug development. Experience managing team resources, budgets, and external vendors or consultants., preferably in a pharmaceutical or biotech environment.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Experience managing cross-functional project activities and deliverables across complex programs

• Strong understanding of the drug development process, including pharmaceutical project management principles and GxP regulations (GLP, GCP, and related guidelines)

• Deep experience managing operational aspects of early-stage drug development, including academic and CRO-based contracts, timelines, and execution

• Demonstrated operational management of Toxicology and Clinical Pharmacology activities

• Proven experience overseeing vendors and consultants, including performance and deliverables management

• Ability to manage multiple priorities in a fast-paced, cross-functional environment

• Demonstrated experience in budget and resource planning, tracking, and management

• Strong interpersonal, negotiation, and problem-solving skills, with the ability to work effectively with business partners and leadership

• Advanced proficiency in Microsoft Project, Word, Excel, and reporting/tracking tools; ability to lead management of Translational Sciences systems and represent the function across tools

• Self-motivated team player who thrives in dynamic environments, with willingness to travel domestically and internationally

   

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI #SL-1

Please note that this position can be based in Princeton, NJ, OR San Diego, CA, OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

This role is responsible for supporting Clinical Operations’ management objectives to perform clinical trials that are of high quality, and that are delivered to agreed timelines and budget. This role manages clinical operations processes including project planning, budget, resource management, and contract research organization management. This role serves as a key contact and resource for Clinical Study Managers, CRA’s and Clinical Trial Assistants. Responsible for ensuring that clinical studies are carried out and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-functionally to ensure that the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.

Primary Responsibilities

· Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally. Works with clinical investigators, other roles, and Clinical Service Providers (CSP) to develop, execute, and deliver clinical studies/programs that are of high quality.

· Ensures quality delivery of study enrollment within agreed budgets and timelines.

· Participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.

· Develops and manages relationships with critical and non-critical 3rd party vendors and clinical site staff; maintains ongoing documentation, performs risk analyses, and may participate in due diligence and audit reviews.

· Effectively communicates project status and issues to management and the team.

· Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)) etc.

· Manages and reviews the work of Contract Research Organization (CRO) to ensure that tasks are performed to scope and budget.

· Liaises with other functional groups to ensure that timelines, budgets, and study objectives are met.

· Liaises closely with Clinical GCP group to ensure that quality metrics are met throughout a trial.

· Oversees clinical study budgets.

· Provides day-to-day direction to Study Managers and Clinical Trial Assistants to carry out their work.

· Ensures compliance with good clinical practices (GCP), good documentation practices (GDP), and regulatory guidelines.

· Recommends and implements innovative process ideas to positively impact clinical trials management.

· Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field. Targeting 8 years’ progressively responsible pharmaceutical experience with a focus on clinical trials and late phase development. Leadership experience and CNS therapeutic experience preferred. An equivalent combination of relevant education and applicable job experience may be considered.

Key Skills:

· Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.

· Experience developing clinical protocols, Standard Operation Procedures (SOP), Clinical Study Reports, and other documents to support New Drug Application (NDA).

· Demonstrated ability to successfully develop, implement, and manage clinical trials.

· Practical experience in clinical trial strategies, methods, and processes; knowledge of clinical trial design.

· Demonstrated technical, administrative, and project management capabilities.

· Strong interpersonal, organizational, and workload planning skills, along with excellent verbal and written communication skills.

· Proficient computer skills, including Microsoft Word and Excel.

· Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the department or segments of the organization.

· Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.

· Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.

· Must be willing and able to travel both domestically and internationally.

#LI-HYBRID #LI-CA1

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director will collaborate with the Clinical Data Management team by providing leadership and knowledge.  Assists the head of Data Management in directing the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives.  Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives.  Focuses on the oversight of quality data deliverables within Acadia Data Management and projects with Contract Research Organizations (CROs).

Primary Responsibilities

• Participates in the collaboration and coordination with others to design and implement clinical protocols and data collection systems.
• Assists in identifying and resolving data management issues on assigned studies.
• Responsible for ensuring data management timelines are met within assigned studies, in-house or outsourced.
• Provides strategic input into protocol design focused on data management portions.
• May assist Biostatistics in development/review of Statistical Analysis Plans.
• Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable.
• Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorisation Application (MAA), including integrated databases. 
• Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities.
• Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality.
• Oversees projects that have been engaged with CROs, as well leads and manages internal projects.
• Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies.
• Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
• Assures compliance with industry quality standards, guidelines and procedures.
• Assists in the selection and evaluation of new personnel to ensure the efficient operation of the function.
• May assist in the career development of Data Management personnel.  Position may have direct reports. May assist with input into corporate and department budget process and management.
• Other responsibilities as assigned.

Education and Experience

• Bachelor’s degree in Life Sciences, Mathematics or related field.  Targeting 8 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry.  An equivalent combination of relevant education and experience may be considered.
• Previous experience in data management from protocol concept through database lock and clinical study report finalization.
• Knowledge of medical terminology.
• Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
• Excellent verbal and written communication skills as well as interpersonal and organizational skills
• Proficiency in MS Office applications.
• Proficiency with data management systems and supporting statistical programs (e.g., SAS),
• Knowledge of database design and database concepts.
• Skilled at cross-functional/department communications to gain cooperation of others.
• Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Must be able and willing to travel on occasion.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-SL1

Seeking talent near: Princeton, NJ, San Diego, CA

Position Summary

The (Senior) Director, Clinical Research will be a highly qualified and motivated individual who will have a leadership role in the development of Acadia programs for rare diseases and/or neurologic and neuropsychiatric disorders. This person will have extensive clinical and scientific knowledge and a strong network in the medical community, and successful experience in leading clinical programs.

Primary Responsibilities

• Create and execute global clinical development plans consistent with the Company’s strategic vision and mission.

• Ensure the optimal planning, implementation and interpretation of clinical studies, including synopsis/protocol development, medical monitoring, data analysis and writing of final reports. 

• Maintain and build productive relationships with investigators, thought leaders and centers of excellence across the scientific community, as well as with colleagues across the Acadia organization.

• Interact frequently with sites to support study awareness, patient recruitment, and quality of study conduct.

• Communicate appropriate program issues and results to key internal and external stakeholders.

• Support regulatory interactions, including the submission of regulatory documents and presentations.

• Provide clear and insightful clinical and scientific expertise to advance the successful transition of compounds from discovery to full development, and subsequently to life cycle management.

• Review business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements.

• Comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practices, and Acadia’s policies and procedures.

• Other duties as assigned.

Education and Experience

MD or equivalent required; Board Certified/Eligible strongly preferred.  Targeting 3-5 years of relevant medical/clinical practice, related research, or academic experience within the pharmaceutical industry.   Ideal candidate will have experience with medical monitoring, including clinical research, creating and implementing development plans and clinical studies.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Applicable industry experience across several phases of development is strongly desired.

• Established relationships with thought leaders and investigators in depression and other mood disorders.

• Experience in rare disease and/or neurology strongly preferred.

• Demonstrated leadership to work well within a geographically diverse cross-functional team environment.

• Ability to work within a growing organization within the U.S. and to help the organization evolve over time into the world leader in rare diseases and neurologic and neuropsychiatric disorders.

• Experience interacting with senior leaders, including global regulatory agencies.

• Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills.

• Demonstrated problem solving abilities and conflict resolution skills.

• Ability to engage in an open, constructive and continuous dialogue with the Company’s stakeholders.

• Highly motivated, self-driven and dependable.

• Willing and able to travel both domestically and internationally.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID

Please note that this position is based in Princeton, NJ or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary:

The Director, Marketing will contribute to the development of the overall Consumer strategy of the brand while leading the management and execution of marketing tactics, plans and activities to promote the brand to caregivers. This role is responsible for shaping patient and caregiver messaging across channels, including direct-to-consumer (DTC) television advertising and educational materials, while ensuring alignment with brand strategy, regulatory standards, and patient-centric principles. The Director will deliver impactful communications that meaningfully engage the caregiver community, and will play a key leadership role within the consumer marketing team. This role will partner across key stakeholders (advocacy, medical affairs, regulatory, legal, compliance, patient services, market access, marketing operations, training, sales, etc.) to execute the programs and tactics identified in the brand plan.

Primary Responsibilities:

• Lead the development and execution of consumer and caregiver marketing initiatives, including core messaging, direct-to-consumer (DTC) television advertising, and educational materials designed to inform, support, and empower families within the Rett community.
• Oversee the caregiver speaker program, including speaker identification, onboarding, and management; development of compliant, engaging speaker content; and ongoing evaluation and optimization of program effectiveness.
• Ensure caregiver speaker materials and presentations are scientifically accurate, compliant, and aligned with brand strategy, with a strong emphasis on clarity, empathy, and patient- and caregiver-focused storytelling.
• Serve as the primary marketing liaison to the Family Support Educator (FSE) team, ensuring alignment between consumer marketing initiatives and field-based educational efforts to deliver a cohesive and consistent caregiver experience.
• Directs the development of strategic marketing programs for inclusion into brand plan, determines metrics for program success, and evaluates performance against metrics including contributions to the development and evolution of message strategy based upon in-depth analytics and ROI analysis. Manages within the established the US promotions budget for assigned products.
• Represents the department as a member of cross-functional project teams providing guidance, insight, and recommendations relative to the goals and objectives of the Marketing function to ensure strategic alignment medical education messaging across groups.
• Monitors and ensures that all Medical Legal Review (MLR) processes are followed, and all programs are compliant with legal guidance and corporate policies.
• Implements the brand strategy for products and product lines. Develops and delivers presentations as needed to commercial management and other internal groups. Monitors progress of plans and recommends adjustments, as necessary.
• Develops and maintains strong external relationships with Advocacy groups, physician speakers and Rett caregivers and families.
• Mentor and develop junior team members by providing clear direction, coaching, and constructive feedback, fostering strong marketing fundamentals, professional growth, and a collaborative, high-performing team culture.Lead day-to-day collaboration with the advertising agency of record, providing strategic direction and hands-on oversight across creative development and execution to ensure consumer-facing campaigns are aligned with brand strategy, patient-centric principles, timelines, and budget.

Education & Experience:

• Bachelor’s degree in marketing, health care, life science; master’s degree preferred.
• Targeting 10+ years of progressively responsible experience in pharmaceutical or biotech Marketing.
• 5+ years in a product manager role strongly desired.
• Launch experience and commercialization of new products preferred.

Required Skills:

• Rare Disease experience is highly desirable, with requirement of understanding specialty therapeutics addressing significant unmet medical needs.
• Strong Biopharmaceutical brand management experience and demonstrated track record of success.
• Proficient in marketing and media tactics directed towards HCPs and caregivers.
• Proficient at effectively prioritizing goals and coordinating resources to achieve those goals.
• Demonstrated ability to interface/collaborate with other departments as necessary to achieve goals.
• Significant travel required; ability to travel up to 50% of time during peak launch time periods.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently overnight up to 25% of the time and work after hours if required by travel schedule or business issues.

#LI-SM1 #LI-HYBRID

Please note that this position is based in San Diego, CA or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary 

Acadia Pharmaceuticals is seeking a seasoned and strategic Health Economics and Outcomes Research (HEOR) leader to serve as Senior Director, HEOR. In this critical role, you will lead the development and execution of comprehensive value evidence strategies that demonstrate the clinical, economic, and humanistic value of Acadia’s therapies across their lifecycle, from development through commercialization and global market access.

As the demand for high quality real world evidence and outcomes research continues to grow, this role will be central to supporting health technology assessments, payer decision making, reimbursement, and product differentiation. You will oversee the generation and dissemination of HEOR evidence, including real world evidence, economic modeling, and clinical outcomes assessments, to support access and adoption across global markets.

The Senior Director, HEOR will be responsible for shaping and communicating the value story for assigned products or indications, leading the development of global value dossiers, economic models, and HTA strategies that clearly articulate the benefit of Acadia’s therapies to patients, healthcare systems, and population health decision makers. This role requires close collaboration with Commercial, Market Access, Clinical Development, Medical Affairs, Regulatory, and other cross functional partners to ensure HEOR strategies are aligned with scientific objectives, business priorities, and regulatory expectations.

The ideal candidate brings deep expertise in outcomes research methodologies, strong scientific and strategic judgment, and the ability to lead complex, cross functional initiatives in a fast paced, global environment. This position offers a unique opportunity to shape evidence strategies that influence access, reimbursement, and ultimately patient outcomes for therapies addressing significant unmet medical needs.

Primary Responsibilities

• Build and implement the strategy for HEOR, including RWE and HTA evidence generation & dissemination within an assigned area for in-line and pipeline assets.
• Lead delivery of value evidence generation strategies throughout the product life cycle.
• Oversee and guide the development and implementation of patient-reported outcomes (PRO) and COA endpoints strategy.
• Ensure the work delivered by HEOR in the assigned area aligns with R&D and corporate goals.
• Represent HEOR on various cross-functional teams in commercial/clinical/medical areas.
• Direct and implement relevant HEOR initiatives with external entities.
• Contribute to the development and execution of overall and HEOR-specific publication plans.
• Establish an integrated HEOR plan aligned with Commercial, Market Access, and Scientific objectives.
• Other duties as assigned.

Education/Experience/Skills

• Master’s degree in public health, economics, epidemiology, health services research or HEOR-related field. 
• Targeting 12 years’ experience in the pharmaceutical or medical device industry; or, a Doctorate in health services research, pharmacy, medicine, public health, economics, and targeting 9 years’ experience in global biopharmaceutical or medical device industry. 
• Experience in outcomes research methodologies (retrospective observational cohort, cross-sectional studies, registries, etc.) to support product development and reimbursement efforts is required. 
•  Must have experience with the execution of scientifically robust qualitative and quantitative studies, development and validation of COA measures, including assisting clinical development teams in implementing COAs in clinical trials to measure patient-relevant endpoints.

Key Skills:

• Understanding of the global healthcare environment, clinical research processes, global regulations, and ethical guidelines.
• Rare disease or CNS experience with interactions with US and ex-US reimbursement agencies is preferred.
• Highly developed communications skills (written/verbal) and interpersonal savvy.
• Proven meeting planning and team facilitation skills.
• Ability to create, track, plan, and communicate project timelines to team members, and maintain budgets.
• Ability to create, track and plan timelines and budgets.
• Ability to support multiple projects while being well-organized, have strong time management skills, and attention to detail.
• Excellent organization and multi-tasking skills.
• Ability to accommodate shifting priorities, demands and timelines.
• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.
• Knowledge of regulatory guidance documents and scientific guidelines (FDA guidance; FDA qualification documentation; dossier outline; EMA guidance resources; ISPOR Task Force Documents, etc.).
• Understanding of instrument development and validation process.
• Strong computer skills (Microsoft Office, etc.) and knowledge of database management (Veeva Vault, etc.).
• Must be able and willing to travel (up to approximately 40%) for conferences, meetings, and HEOR project or team-management related business.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-SW1

#LI-Hybrid

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director, Vendor & Relationship Management will support and optimize strategic partnerships with clinical vendors, CROs, and functional service providers to ensure operational excellence, compliance, and value delivery across global clinical development programs. This role will drive vendor governance, performance management, and continuous improvement initiatives while collaborating cross functionally to support R&D business objectives and foster a culture of partnership and innovation.  The Associate Director will partner closely with R&D stakeholders, Procurement, Quality, Finance, and Legal to enable effective vendor oversight and consistent outsourcing practices across the Acadia R&D organization.

Primary Responsibilities

Vendor & Relationship Management

• Support the development and execution of vendor and supplier relationship management strategies, including identification and management of critical partners (CROs, central and specialty labs, functional service providers, clinical technologies, patient recruitment and retention vendors).

• Serve as a primary point of contact for vendor related operational issues, coordinating resolution and escalating unresolved matters through established governance pathways.

• Coordinate and facilitate, when appropriate, vendor governance, including operational and steering committee meetings.

• Develop and maintain supplier scorecards, dashboards, and KPIs to monitor vendor performance and identify trends and risks.

• Conduct routine business reviews with vendors to ensure alignment on priorities and performance expectations, partnering with Sourcing and Legal as needed.

Operational Oversight & Excellence

• Oversee vendor performance supporting outsourced clinical trials, through partnership with the Clinica Operations team. Ensure alignment with program timelines, budgets, and quality expectations.

• Partner with Clinical Operations, Clinical Supply Chain, Quality, Finance, and other cross functional teams to support timely and compliant delivery of services.

• Support inspection readiness activities, including audits, vendor oversight documentation, and CAPA development in collaboration with Quality.

• Contribute to process mapping, documentation, and implementation of standardized vendor oversight practices.

Innovation & Continuous Improvement

• Identify opportunities to improve vendor performance, efficiency, and collaboration through data driven insights and process improvements.

• Support innovation initiatives within vendor relationships, including new operating models, technologies, or ways of working.

• Contribute to the development and rollout of best practices, standards, and tools for R&D vendor management.

• Identify opportunities for cost optimization, demand management, and improved vendor utilization.

Data, Reporting & Technology Enablement

• Support the development and maintenance of vendor performance reporting and dashboards.

• Analyze performance metrics to proactively identify risks, issues, and opportunities for improvement.

• Partner with internal teams to support implementation and optimization of vendor management tools and systems.

• Act as a mentor and subject matter resource for team members and matrixed stakeholders involved in vendor oversight.

• Foster strong, collaborative relationships with internal stakeholders and external partners to enable transparent communication and proactive issue resolution.

• Effectively influence stakeholders across a matrixed organization without direct authority.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life science or a related field; Advanced degree preferred.  Targeting 8 years of experience in clinical trial operations, vendor/CRO oversight, supplier relationship management, or related roles within the biopharmaceutical industry.  Experience managing complex vendor relationships and supporting performance improvement initiatives required.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong understanding of clinical trial operations and outsourced service models.

• Working knowledge of ICH GCP, regulatory requirements, and quality expectations for outsourced clinical activities.

• Strong analytical skills, including experience with supplier scorecards, KPIs, and performance dashboards.

• Experience in R&D outsourcing, vendor governance, or business operations functions.

• Exposure to financial management of outsourced services, including budgeting and accruals.

• Experience supporting audits, inspections, or inspection readiness activities.

• Familiarity with alliance or partnership management methodologies.

• Excellent communication, interpersonal, and organizational skills.

• Ability to work effectively in a fast paced, matrixed environment while managing multiple priorities and working cross-functionally.

• Willing and able to travel both domestically and internationally.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HBRID #NC1

Seeking talent near: Princeton, NJ : San Diego, CA

Position Summary:

The Associate Director, Business Development will work collaboratively with a variety of company functions including External Innovation (Acadia’s R&D Search and Evaluation team), Commercial, and Finance as well as external resources to review, landscape, identify and evaluate external assets to support and enhance the Acadia portfolio.  We are seeking an individual with strong analytical and evaluation skills including data gathering and analysis, financial modeling experience and related analysis, competitive intelligence and scientific/commercial analysis of companies and programs in the pharmaceutical and biotech industry, as well as experience with BD transactions.  The person in this role must have experience in identifying and analyzing the value of companies and programs within the pharmaceutical industry, building a business case for potential BD opportunities, and working with Executive management to implement corporate Business Development (BD) strategies. 

Primary Responsibilities:

• Conducts extensive searches using industry resources to identify and evaluate potential BD opportunities.
• Constructs forecasts, recommendations and strategic/tactical plans based on business data and market knowledge.
• Develop a solid business case and provide other general support for BD transactions including scientific, commercial and financial considerations.
• Conducts search efforts to identify business development acquisition or in-licensing opportunities.
• Role supports and coordinates activities related to the search, identification, competitive intelligence, and business case for potential transactions, working with the External Innovation and Commercial teams who lead the scientific and commercial assessments, which are incorporated into the overall deal package by BD.
• Performs in-depth evaluations, interpreting competitive landscape and analysis of financial data.
• Develops and manages complex revenue & cash flow NPV models and assist in production and testing assumptions related to overall commercial opportunity modeling (e.g., future markets, product performance, customers & compliance and competitors). Works with Finance to create forecasting and deal evaluation models.
• Maintains awareness and knowledge of product strategy to assess fit of potential candidates.
• Stays abreast of emerging healthcare & pharmaceutical industry trends and assess their potential impact on business strategies.

Education/Experience/Skills:

Targeting a minimum of 5 years of progressively responsible experience within consulting, venture capital or investment banking with a focus on valuation of and strategic transactions related to of therapeutics/companies in the pharmaceutical or biotech industry. M.D., advanced degree in a relevant scientific discipline (e.g., Ph.D.), or an MBA or functional equivalent, is required. Experience in the rare disease and CNS space. A combination of relevant education and applicable job experience may be considered.

Must possess:

• Scientific knowledge of industry sub-segments of CNS, Neurology or Orphan/Rare disease as well as industry functional areas of R&D, Clinical Development and Commercial/New Product Planning.
• Extensive experience developing and using Excel-based models including working on/developing complex financial models.
• Experience in competitive analysis, market research and analysis, and new product development needed.
• Expertise with Microsoft Office applications (Word, Excel, PowerPoint) with a strong focus on PowerPoint presentation skills
• Excellent analytical abilities: ability to draw conclusions and present recommendations on a variety of data.
• Ability to create and deliver influential large scale project communications with clarity, confidence and enthusiasm.
• Demonstrated ability to manage projects and time with multiple commitments/projects simultaneously.
• Superior written / verbal communication, organizational and analytical skills
• Critical thinking skills with the ability to get to the right level of granularity to balance speed of execution and facilitate optimal decision-making by executive management.
• Excellent financial analysis and research skills and ability to translate analyses into sound strategic recommendations.
• Ability to work in a results-oriented, project-driven, real-time team environment, prioritize projects and deliver quality results within tight time constraints.
• Ability to think strategically as well as to act tactically.
• Excellent database skills.
• Ability to travel.

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication both in a standard office environment and while working independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedule or business needs.

Seeking talent near: Princeton, NJ; San Diego, CA

Position Summary:

Responsible for coordination of packaging (package design), artwork, and serialization with commercial Drug Product Contract Manufacturing organizations (CMO’s), and other third party suppliers for products as identified. Subject matter expert in the field of serialization to oversee our CMOs running commercial and Acadia data management and integration.

Experienced in the technical aspects of product introduction into the EU and other global markets as related to serialization, package design, and local requirements.

Primary Responsibilities:

• Develops and maintains good working relationships with both internal stakeholders and contract manufacturers.
• Acquires and maintains scientific and technological knowledge and background of existing and new pharmaceutical (surface) serialization technologies to ensure our CMOs are aligned. Verifies CMO serialization technologies and ensures compliance with pharmaceutical regulatory requirements (EU FMD and DSCSA).
• Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
• Maintains and follow through a consolidated Acadia Manufacturing action log to ensure all manufacturing related actions are completed on time.
• Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings.
• Works with Quality Group and Acadia Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
• Provide onsite process coverage as person-in-plant as needed
• Develops, collects appropriate internal and external metrics to measure CMO and Acadia performance.
• Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
• Supervise, train and mentor personnel as needed.

Education/Experience/Skills:

BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience.  Scientific advanced degree a plus.  A minimum of 8 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.

Must possess:

• Contract service provider experience.
• Strong understanding is required of the biopharmaceutical serialization and packaging process
• Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
• Extensive knowledge of current Good Manufacturing Practices (cGMPs)
• Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
• Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
• Domestic and International travel is required for this role.
• Experience in a cGMP environment
• Capability to communicate efficiently and effective about issues of a complex (technological and scientific) nature
• Attention for detail

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.   Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.

#LI-NC1 #LI-HYBRID

Please note that this position can be based in Princeton, NJ OR San Diego, CA. Acadia's hybrid model requires this role to work in our office an average of 3 days per week.

Position Summary:

Responsible for the chemical process development, implementation and management of robust, cost effective, and safe processes for the manufacture of APIs from the research stage, through clinical development and marketing approval. Will be responsible for the technical development, support, innovative solutions and commercialization of drug substances using an external network of providers. This position is integral to the advancement of ACADIA’s growing portfolio of drug candidates, and will provide technical oversight, expertise and guidance of externalized drug substance development related activities.

Primary Responsibilities:

• Lead scientific strategy for drug substance development, ensuring scalable, efficient, and compliant processes that meet clinical and commercial needs

• Oversee contract service providers (CSPs) to develop, optimize, and scale manufacturing processes from preclinical through commercialization

• Apply risk assessments and Quality by Design (QbD) principles to define design space and establish robust control strategies

• Develop end-to-end drug substance strategies supporting product quality, global regulatory approvals, and supply chain flexibility

• Manage technology transfer, outsourcing, and external manufacturing to build a reliable and scalable supply chain

• Establish, evaluate, and manage CSP partnerships, including contract negotiation, performance oversight, and issue resolution
  

• Ensure cGMP compliance, oversee deviations and change management, and partner with Quality and Regulatory to assess impact on filings

• Lead planning and execution of timelines, deliverables, and CMC documentation to support regulatory submissions and inspections
  
  
• Provide cross-functional leadership and technical expertise, supporting internal teams, governance forums, and external diligence activities

Education/Experience/Skills:

Ph.D. degree in Synthetic Organic Chemistry or other related scientific discipline. A minimum of 8 years of relevant progressive experience in API development and manufacturing in the pharmaceutical/biotechnology industry with a minimum of 5 years in a scientific role. An equivalent combination of relevant education and applicable job experience may be considered.

Requirements:

• Leadership experience in managing diverse project activities with contract CDMO facilities at different global locations

• Experience with global pharmaceutical/chemical development and manufacturing operations for development-stage small molecules, including upstream/downstream process development. Well-versed in drug substance manufacturing control strategies

• Highly knowledgeable with FDA and ICH guidelines relating to registration, quality and compliance with small molecule drug substance

• Awareness of scientific developments and opportunities in chemistry/chemical engineering

• Strong understanding of organic synthetic chemistry concepts and cross-functional understanding related to API development from pre-IND through NDA

• Chemistry Manufacturing Controls (CMC) expertise to prepare documents for regulatory filing (e.g. IND to NDA)

• Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs

• Excellent communication, interpersonal and presentation skills. Ability to effectively collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)

• Skilled at negotiating with business partners/management and influencing senior level leaders regarding matters of significance to the organization. Demonstrated problem-solving abilities and conflict resolution skills

• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary:

Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMO’s), and other third-party suppliers for products as identified. Responsible for tracking of ongoing manufacturing schedules to ensure commercial supply levels are maintained and inventory targets are met. Responsible for technical and business evaluation of manufacturing network.

Primary Responsibilities:

• Team and Project Leadership, capable of leading manufacturing activities and coordinating activities across a matrix team. A SME in DP manufacturing, knowledgeable in development, quality, and regulatory requirements for manufacturing.
• Manage all aspects of DP Manufacturing from authoring and revision of manufacturing documents (MBRs, Protocols, QRAs, etc), oversight of manufacturing operation, managing deviations, investigations, and relevant change actions, supporting product release, and ensuring the finished product arrives in warehouse for distribution.
• Responsible for DP vendor selection process for new commercial suppliers or for alternative suppliers. 
• Develops and maintains good working relationships with contract manufacturers.
• Develop and maintain Drug Product manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource.
• Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
• Maintains and follow through a consolidated Acadia Manufacturing action log to ensure all manufacturing related actions are completed on time.
• Provide onsite process coverage as person-in-plant as needed
• Develops, collects appropriate internal and external metrics to measure CMO and Acadia’s performance.
• Communicates manufacturing or technology related issues and information to Manufacturing production team members, TDO stakeholders, and other members of the project team.
• Supervise, train and mentor personnel as needed.
• Prepare Annual Product Reports with Manufacturing CMOs according to Acadia’s needs.
• Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings.
• Works with Quality Group and Acadia Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.

Education/Experience/Skills:

BS, MS, or PhD in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience.  A minimum of 12 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.

Must possess:

• Contract service provider experience.
• Strong understanding is required of biopharmaceutical manufacturing including regulatory filings and quality inspections and audits.
• Strong business acumen.
• Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
• Extensive knowledge of current Good Manufacturing Practices (cGMPs)
• Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
• Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
• Domestic and International travel is required for this role.

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #NC1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Clinical Pharmacology will bring deep expertise across both preclinical and clinical development, with a strong track record of success in advancing drug candidates through early development. This individual will serve as a key representative of the Clinical Pharmacology function on cross-functional Asset Teams and will be responsible for leading early-stage programs. Core responsibilities include the strategic planning and execution of Phase 1 clinical trials, including First-in-Human (FIH) and proof-of-concept (PoC) studies in healthy volunteers.  This role supports drug development across multiple therapeutic areas, with a focus on neuroscience.

Primary Responsibilities

• Interpret nonclinical data and translate findings into clinical pharmacology development plans that position Acadia programs for successful clinical transitions

• Design and oversee early-phase clinical trials (e.g., FIH, food effect, DDI studies)

• Collaborate with colleagues on the selection and implementation of appropriate 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 (TLFs) for Phase I studies

• Represent Translational Sciences / Clinical Pharmacology within asset teams

• Support regulatory submissions including IND enabling packages, NDAs, MAAs, and NDSs

• Acquire and maintain knowledge of national and international regulatory guidelines

• Collaborate effectively with multidisciplinary teams including clinical, regulatory, nonclinical, and CMC functions to ensure alignment and integration of clinical pharmacology strategies

• Ensure compliance with GCP, ICH guidelines, and internal Standard Operating Procedures (SOPs) for all clinical pharmacokinetic-related studies

• Work with the quality assurance team on SOP development, revision, and implementation

• Evaluate licensing and partnership opportunities, with a focus on clinical pharmacology aspects

• Other duties as assigned

Education/Experience/Skills

• Ph.D. in Pharmacology or related field.  Targeting 10 years of relevant industry experience, including all aspects of drug development.  An equivalent combination of relevant education and experience may be considered

• Track record of successful design and execution of Phase I studies

• Proven success in the design and selection of endpoints for PoC studies in healthy volunteers

• Deep knowledge of requirements for clinical pharmacology-related regulatory submissions (IND, NDA/MAA/NDS), with hands-on filing experience

• Experience in rare disease is a strong plus

• Strong analytical and problem-solving skills, with the ability to integrate multifactorial inputs into clear and actionable strategies

• Strong organizational skills and able to effectively multitask and prioritize

• Excellent interpersonal skills, with the desire to work as part of a multi-functional team

• Excellent written and verbal communication skills

• Excellent trouble-shooting and decision-making skills; able to listen to and consider different functional perspectives and escalate response to situations when appropriate

• Ability to identify inconsistencies and ensure accuracy in all aspects of work

• Must be able to travel on occasion

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director will be responsible for the oversight of Translational Science preclinical safety assessment/toxicology deliverables, with a clear understanding of functional interdependence and critical path activities. The role will contribute to the research and/or development of the products, projects, and programs in support of the pipeline.  Collaborate cross‑functionally to conduct basic research and development, including designing and overseeing preclinical safety and toxicology studies in support of diverse projects and long-term company objectives.  Ensure timely and effective communication of project status and issues to drive alignment and successful completion of team goals and deliverables.

Primary Responsibilities

• Plans experimental safety assessment/toxicology programs to include design, logistics, resource allocation, schedules. Identifies critical support needs, and other necessary details to implement the program(s).

• Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions and nonclinical post marketing approval requirements.

• Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology studies.

• Manages vendors and consultants, encompassing study design, detailed coordination of study execution, overview of quality compliance, and scientific rigor.

• Reviews and contributes to preparation of toxicology reports.

• Maintains oversight of test compound delivery, shipment and supply requirements.

• Works cross functionally on projects including an understanding of when broader discussion is required and the organization ad hoc working groups as needed to move project activities forward.

• Communicates project status and proactively identifies issues to ensure that project team goals and regulatory deliverables are met.

• Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.

• Other duties as assigned.

Education/Experience/Skills

BS or MS in a relevant discipline or a related field. Targeting 8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within the pharmaceutical or biotech industry.  DABT Certification strongly preferred. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Understanding of the drug development process and the principles, concepts, practices, and standards of executing preclinical safety assessment/toxicology strategies.

• Knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation, including the various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research and ability to evaluate the advantages and disadvantages of each, in terms of applicability to the research at hand.

• Knowledge of the preclinical study types necessary during drug development, including acute and chronic toxicology, safety pharmacology, developmental and reproductive toxicology, genotoxicity and carcinogenicity.

• Experience working in cross-functional project teams and in a semi-virtual environment including CROs and academic collaborations.

• Study monitoring experience on Good Laboratory Practices (GLP) safety assessment/toxicology studies at CROs.

• Experience in the composition and review of preclinical safety assessment/toxicology reports with respect to accuracy, quality and compliance.

• Knowledge and understanding of GLP, ICH and FDA guidance, and other relevant regulations and guidelines.

• Demonstrated skills and abilities in influencing, facilitation, development, and problem solving. Ability to elicit cooperation from a wide variety of sources and to be influential, encouraging and motivating.

• Excellent communication, presentation, consultative, partnership, and interpersonal skills. Self-motivated and able to work with limited supervision. 

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

• Must be able and willing to travel as needed.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

Please note that this position can be based in Princeton, NJ, San Diego, CA, or San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Sr. Director, Commercial Advanced Analytics & Data Strategy is a strategic leadership role responsible for defining, building, and scaling the analytics capabilities, data strategy, and governance frameworks that enable commercial decision-making across the organization. This role ensures that high quality data, advanced analytics, and AI enabled insights are seamlessly integrated into commercial strategy, planning, launch execution, and in market optimization.  The Sr. Director serves as a strategic partner cross-functionally, translating business priorities into scalable analytics products and platforms while ensuring governance, compliance, and measurable business impact.

Over time, this role will build and mature commercial advanced analytics and data capabilities, establish fit‑for‑purpose operating models, and define future talent and capability needs to support the evolving business. The role will work closely with Acadia’s AI team, which provides shared AI expertise across Commercial and R&D, as well as with IT teams responsible for enterprise data, infrastructure, and platform enablement.

Primary Responsibilities

Commercial Analytics Strategy & Leadership

• Partner with Commercial leadership to define the advance analytics vision, strategy and initiatives that enables the development of scalable analytics and decision-support capabilities that drive business outcomes

• Lead and govern advanced analytics projects, predictive analytics, and AI/machine learning solutions  supporting brand strategy, launch planning, patient support, segmentation, targeting, omnichannel optimization, and sales effectiveness.

• Enable AI-driven commercial use cases such as next-best-action, customer engagement optimization, automated forecasting, and scenario planning.

• Balance innovation with rigor by ensuring analytics solutions are interpretable, validated, and compliant with internal and external requirements including privacy laws

• Translate commercial business questions into analytics use cases, models, and decision frameworks.

• Ensure analytics outputs and insights are actionable, adopted, and embedded into commercial planning, existing workflows, processes, systems and demonstrate measurable outcomes.

• Act as a trusted advisor to Commercial leadership, influencing decisions through data-driven insights

• Partner with the Enterprise AI team to identify, prioritize, and scale high-value AI and advanced analytic capabilities, solutions and governance.

Data Strategy, Governance and Cross-Functional Enablement Leadership

• Establish commercial data strategy to support the organization in achieving its business objectives. This includes leading the acquisition, implementation, and evolution of the commercial data assets, including syndicated claims, EMR, prescription, HUB/SP/Partner, promotional, and digital data.

• Partner cross-functionally with Enterprise Data, IT, and infrastructure teams to enable scalable data platforms, data pipelines, and tools that support analytics, AI, and self-service insights.

• Oversee vendor selection and management for data sources, analytics tools, and platforms.

• Establish governance frameworks for data access, analytics validation, and model lifecycle management.

• Collaborate with legal/compliance teams to mitigate risk and ensure compliance with HIPAA, GDPR, CCPA, and internal data privacy and security policies.

• Partner with IT data and infrastructure teams to align commercial analytics needs with enterprise architecture, platform standards, security requirements, and long-term data strategy.

Leadership & Communication

• Serve as a bridge between business stakeholders and technical teams, ensuring clarity of requirements and outcomes.

• Influence senior executives through concise storytelling, visualization, and business impact measurement.

• Build, lead, retain and mentor a high-performing team and capability in support of advanced analytics, data acquisition, and data governance, while fostering a culture of accountability, continuous improvement, and innovation.

• Assess and evolve organizational capabilities, talent, and ways of working needed to scale commercial advanced analytics over time.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in data science, statistics, engineering, computer science, or a related field; Advanced degree (MS, PhD, or MBA) preferred.  Targeting 12 years of progressively responsible experience in commercial analytics, data science, or data infrastructure data strategy, or related functions, with significant experience in biotech or pharmaceutical organizations.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced analytics, modeling, and visualization tool experience (AI/ML, predictive analytics (Python), SQL, R and PowerBI).

• Experience working with modern data platforms and cloud technologies (e.g., Snowflake, Databricks, DataRobot, Dataiku, AWS, Azure, GCP).

• Deep experience and understanding of commercial datasets, data environments, and data vendors (including Hub, Specialty Pharmacy, patient services, Veeva CRM, syndicated claims, prescriptions, payer, social media/website, Google, Facebook etc.).

• Proven ability to lead cross-functional AI/ML and Analytical initiatives and influence senior stakeholders and to drive adoption of analytic solutions.

• Solid understanding of pharmaceutical commercialization concepts including launches, brand planning, and lifecycle management.

• Demonstrated experience in leading data governance initiatives and processes.

• Demonstrated ability to design and communicate complex systems and analytical solutions to both technical and non-technical audiences, aligning resources and execution to achieve functional and enterprise goals.

• Proven abilities with executive-level communication, data storytelling, and change leadership.

• Demonstrated impact of analytics on commercial strategy, decision making, performance, and ROI.

• Proven ability to lead, coach, and develop talent while building organizational capability in a fast-evolving environment.

• Experience partnering effectively with cross-functional partners and business stakeholders to deliver scalable analytics solutions.

• Ability to balance strategic vision with hands-on prioritization and execution in fast past environment.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-CA1

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Drug Safety & Pharmacovigilance is a medical safety expert within the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the Acadia portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products. 

Primary Responsibilities

• Serves as the primary medical safety resource for assigned Acadia products, providing product-level clinical safety and pharmacovigilance expertise across all stages of development and post-marketing surveillance
• Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, ad hoc safety assessments, and benefit-risk analyses; escalates complex or novel safety issues appropriately
• Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
• Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
• Performs medical review of all serious adverse events from Acadia clinical trials for assigned products
• Performs retrospective medical review of adverse events for post-marketed products
• Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
• Provides oversight for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
• Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
• Formulates response strategies and authors health authority responses for safety-related queries pertaining to assigned products, in collaboration with the Head of Medical Safety
• Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
• Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
• Ensures all PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and Acadia standards
• Maintains current knowledge of global regulatory authority regulations and guidance
• Other responsibilities as assigned

Education/Experience/Skills

• MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience; candidates who are eligible for U.S. medical board certification are preferred. MPH or pharmacoepidemiology training is a plus. 
• 6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment.  
• Neurology, psychiatry, rare disease, or CNS-related therapeutic area experience strongly preferred
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
• Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
• Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
• Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
• Strong analytical and critical decision-making skills; ability to manage competing priorities and meet deadlines with minimal oversight
• Experience with pharmacovigilance safety databases (Argus) and signal detection tools
• Familiarity with pharmacoepidemiology concepts and study design
• Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
• Proficiency in MS Office Suite (Word, PowerPoint, Excel)
• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment
• Must be willing and able to travel both domestically and internationally

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID 

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally, collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities
 

• Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team, late-stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.  A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.  Demonstrated success in the field of formulations and dosage form development.   Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel to domestic and international locations is required.

#LI-HYBRID #NC1 

Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

#LI-HYBRID #NC1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

Responsible for the oversight of Translational Medicine preclinical safety assessment/toxicology deliverables, with a clear understanding of functional interdependencies and critical path activities.  The role will contribute to the research and/or development of the products, projects, and programs in support of the pipeline. Conducts and collaborates with others on basic research and development including preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Conducts and collaborates with others on basic research and development including designing and monitoring preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Responsible for the communication of project status and issues and develops strategies to ensure project team goals and deliverables are met.

Primary Responsibilities

• Plans experimental safety assessment/toxicology programs to include design, logistics, resource allocation, schedules.  Identifies critical support needs, and other necessary details to implement the program(s).

• Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions and nonclinical post marketing approval requirements.

• Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology studies.

• Manages vendors and consultants to complete Translational Medicine safety assessment/toxicology studies for the various programs.

• Responsible for preparation and review of reports and regulatory documents for IND and NDA submissions. Explore innovative approaches to enhance efficiency of toxicology evaluations.

• Supports business development related nonclinical Tox/ADME assessments and due diligence projects by assessing available study data and regulatory submissions, identifying gaps, defining additional nonclinical study plans and test compound requirements, and developing overall project timelines and associated budgets.

• Supports Impurity/Degradant safety assessment reviews requested by Chemistry, Manufacturing, and Controls (CMC) groups, involving public domain literature reviews, evaluating structure activity relationships using in silico databases, and competitive intelligence sources.

• Works across functional areas on projects including lleading and participation in team and sub-team meetings and organizing ad hoc working groups as needed to move project activities forward. 

• Communicates project status and issues and ensures project team goals and regulatory deliverables are met. Clearly presents data, interpretation and recommendations to R&D leadership.

• Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.

• Other duties as assigned.

Education/Experience/Skills

PhD or DVM in a relevant discipline or related field.  Targeting 10 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development experience within the pharmaceutical or biotech industry.  DABT Certification strongly preferred.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced understanding of the drug development process and the principles, concepts, practices, and standards of executing preclinical safety assessment/toxicology strategies.

• Broad knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation, including the various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research. Through a complete understanding of the tools and design methods, able to evaluate the advantages and disadvantages of each, in terms of applicability to the research at hand.

• In depth knowledge of the preclinical study types necessary during drug development, including acute and chronic toxicology, safety pharmacology, developmental and reproductive toxicology, genotoxicity and carcinogenicity.

• Experience managing cross-functional project teams and working in a semi-virtual environment including CROs and academic collaborations.

• Specific direct study monitoring experience on Good Laboratory Practices (GLP) safety assessment/toxicology studies at CROs.

• Experience in the composition and review of preclinical safety assessment/toxicology reports with respect to accuracy, quality and compliance.

• Knowledge and understanding of GLP, ICH and FDA guidance, and other relevant regulations and guidelines.

• Demonstrated skills and abilities in leading teams and sub-teams, coaching, influencing, facilitation, development, and problem solving. Passion for science and teamwork with self-motivation and ability to work with limited supervision.

• Excellent communication, presentation, consultative, partnership, and interpersonal skills. Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

• Willing and able to travel as needed.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director, Trial Master File (TMF) Oversight & Inspection Readiness (IR) is responsible for leading the operational oversight of the TMF and supporting the framework that ensures Trial Master File integrity, sustained inspection readiness, and regulatory compliance within Clinical Operations.  This role leads TMF health governance, inspection preparedness, and risk identification processes to safeguard the organization during regulatory inspections and audits.  The Associate Director serves as the Clinical Operations lead for inspection defense, by advancing consistent standards, proactive risk visibility, and clear organizational insight into TMF integrity and inspection readiness.

Primary Responsibilities

TMF Oversight & Governance

• Establish TMF health oversight framework across studies, ensuring compliance with GCP and industry standards.

• Monitor TMF quality metrics across programs, ensuring completeness, timeliness, and accuracy of essential documents; Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.

• Lead and share TMF best practices with internal and external stakeholders, as appropriate. Oversee TMF risk trending and remediation plans.

• Maintain inspection-readiness standards for documentation.

Inspection Readiness Leadership

• Develop and maintain a sustainable inspection readiness model, including development and maintenance of comprehensive inspection readiness tools, reference materials and coordinating training guidance to staff on preparation efforts for health authority inspections.

• Lead inspection storyboarding and narrative development. Coordinate inspection preparation activities. Lead designated Clinical Operations activities during regulatory inspections.

• Support post-inspection CAPA alignment, in partnership with Quality.

• Support Clinical Operations team on all inspection commitments, responses, post-inspection activities and implementation of corrective and preventative actions; provide lessons learned from mock and actual inspections. Ensure portfolio-level visibility of inspection risk.

Other Responsibilities

• Partner cross-functionally to align on audit and inspection strategy, as well as TMF platform integrity. Align with functional study teams on TMF accountability expectations. Maintain awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.

• Other responsibilities as required.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field; Advanced degree preferred.  Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience, with at least 5 years TMF experience in a leadership role.  Health Authority inspection and eTMF experience is required. An equivalent combination of relevant education and experience may be considered.

Key Skills

• Thorough understanding of GCP and ICH guidelines; thorough understanding of the drug development process.

• Knowledge and understanding of the current regulatory requirements (e.g., FDA, EMA, MHRA) in a global environment.

• Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group is preferred.

• Veeva Vault eTMF/CTMS experience preferred.

• Ability to lead, motivate, and influence others, including prior leadership experience, is strongly preferred.

• Adept at creating and communicating a clear vision among, effectively aligning resources and motivating stakeholders to achieve goals.

• Demonstrated analytical abilities and proficient planning and negotiation skills. Demonstrated technical, administrative and project management capabilities. 

• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.

• Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output. Demonstrated problem-solving abilities, with strong attention to detail. 

• Able and willing to travel both domestically and internationally.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

#LI-Hybrid #LI-SL1