Director Clinical Pharmacology Bioanalytical

Acadia Pharmaceuticals; San Diego (CA); Hybrid; USD 151,000 - 189,000; Full time

Job summary

An innovative company is seeking a Director of Clinical Pharmacology to spearhead bioanalytical strategies for transformative therapies. This pivotal role involves leading assay development, ensuring regulatory compliance, and collaborating with cross-functional teams. The ideal candidate will have a Ph.D. and 10 years of experience in the pharmaceutical industry, showcasing expertise in mass spectrometry and ligand binding assays. Join a dynamic team dedicated to advancing neuroscience breakthroughs and making a meaningful impact on patients' lives. This position offers a hybrid work model, allowing for flexibility while contributing to groundbreaking research.

Benefits

Discretionary Bonus

Equity Awards

Flexible Work Schedule

Health Insurance

Retirement Plan

Qualifications

• 10 years of experience in the pharmaceutical industry required.
• Strong foundation in preclinical and clinical pharmacology.

Responsibilities

• Lead bioanalytical assay development and validation.
• Ensure compliance with GLP/GCLP regulations.
• Manage relationships with external CROs.

Skills

Assay Development

Mass Spectrometry

Ligand Binding Assays

Regulatory Guidelines

Communication Skills

Team Collaboration

Problem-Solving Skills

Attention to Detail

Education

Ph.D. in Chemistry

Ph.D. in Biochemistry

Ph.D. in Pharmacology

Job description

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us atAcadia.comand follow us onLinkedInandX.

*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

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).

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.

Primary Responsibilities

• Establish bioanalytical and biomarker assay development strategies to support context of use
• Work effectively within cross-functional team environments, conceive and communicate strategy and reduction to practice
• 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)
• Oversee the execution of bioanalytical studies, ensuring compliance with GLP/GCLP regulations
• Analyze and interpret bioanalytical data, providing scientific insights and recommendations
• Establish and manage productive relationships with external CROs and ensure timely delivery of high-quality data
• Prepare and review technical reports, standard operating procedures (SOPs), and regulatory submissions
• Stay current with advancements and innovations in bioanalytical and biomarker technologies and regulatory requirements
• Act as a subject matter expert at bioanalytical compliance and regulatory audits
• Perform other duties as assigned

Education/Experience/Skills

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.

Key Skills:

• Proven track record in assay development, validation, and troubleshooting
• Strong understanding of regulatory guidelines (e.g., FDA, EMA) related to bioanalysis
• Excellent communication and interpersonal skills
• Proven ability to work effectively in a team-oriented environment and present complex information clearly and effectively
• Demonstrated ability to successfully interact with internal staff and manage external bioanalytical vendors, including CROs
• Strong foundation in preclinical and clinical pharmacology with working knowledge of cross-functional interfaces that are important for efficient drug development
• Ability to work independently, take initiative and complete tasks to deadlines
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Ability to think creatively and strategically, with strong problem-solving skills
• Highly motivated with a passion for drug development
• Ability to effectively present information to leaders, external contractors and employees at all levels of the organization
• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables
• Ability 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 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.

#LI-SW1 #LI-HYBRID

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range $151,000 — $189,000 USD

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete ourReasonable Accommodation Request Formor contact us [e-mail]858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.