<ul> <li>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. </li></ul> <p>Position Summary</p> <p>We are seeking a scientifically driven and strategic Director, Clinical Pharmacology - Bioanalytical to lead the development, validation, and oversight of bioanalytical and biomarker assays that support our clinical and nonclinical drug development programs. This pivotal role is responsible for setting bioanalytical strategies and ensuring the delivery of high-quality, regulatory-compliant data through effective partnerships with Contract Research Organizations (CROs).</p> <p>As a senior scientific leader, you will apply deep expertise in ligand binding assays, mass spectrometry, and regulatory guidelines to design and guide bioanalytical plans across therapeutic programs. You will collaborate cross-functionally with internal stakeholders and external partners, serving as a key subject matter expert in bioanalysis and biomarker assay development. This is an exciting opportunity to contribute meaningfully to the development of transformative therapies within a fast-paced, innovative, and team-oriented environment.</p> <p>Primary Responsibilities</p> <ul> <li>Establish bioanalytical and biomarker assay development strategies to support context of use </li><li>Work effectively within cross-functional team environments, conceive and communicate strategy and reduction to practice </li><li>Design, develop, and validate bioanalytical and biomarker assays, including ligand binding assays (e.g., ELISA, MSD) and mass spectrometry-based assays (e.g., LC/MS) </li><li>Oversee the execution of bioanalytical studies, ensuring compliance with GLP/GCLP regulations </li><li>Analyze and interpret bioanalytical data, providing scientific insights and recommendations </li><li>Establish and manage productive relationships with external CROs and ensure timely delivery of high-quality data </li><li>Prepare and review technical reports, standard operating procedures (SOPs), and regulatory submissions </li><li>Stay current with advancements and innovations in bioanalytical and biomarker technologies and regulatory requirements </li><li>Act as a subject matter expert at bioanalytical compliance and regulatory audits </li><li>Perform other duties as assigned </li></ul> <p>Education/Experience/Skills</p> <p>Ph.D. in Chemistry, Biochemistry, Pharmacology, or a related field. Targeting 10 years' relevant experience in the pharmaceutical industry. An equivalent combination of relevant education and experience may be considered.</p> <p>Key Skills:</p> <ul> <li>Proven track record in assay development, validation, and troubleshooting </li><li>Strong understanding of regulatory guidelines (e.g., FDA, EMA) related to bioanalysis </li><li>Excellent communication and interpersonal skills </li><li>Proven ability to work effectively in a team-oriented environment and present complex information clearly and effectively </li><li>Demonstrated ability to successfully interact with internal staff and manage external bioanalytical vendors, including CROs </li><li>Strong foundation in preclinical and clinical pharmacology with working knowledge of cross-functional interfaces that are important for efficient drug development </li><li>Ability to work independently, take initiative and complete tasks to deadlines </li><li>Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines </li><li>Ability to think creatively and strategically, with strong problem-solving skills </li><li>Highly motivated with a passion for drug development </li><li>Ability to effectively present information to leaders, external contractors and employees at all levels of the organization </li><li>Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team's ability to achieve goals and meet timelines/deliverables </li><li>Ability to travel on occasion </li></ul> <p>Physical Requirements:</p> <p>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 may 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.</p> <p>#LI-SW1 #LI-HYBRID</p>