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 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 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 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