For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.
Responsible for Clinical Pharmacology deliverables across all of the therapeutic areas at ACADIA with a clear understanding of functional interdependencies and critical path activities. The Director of clinical pharmacokinetics is an integral member of the project teams, represents the department and provides subject matter expertise, assists in developing and applying clinical pharmacokinetic strategies from early development (pre-IND) through NDA filings of different drug products in development. In this role the candidate is expected to provide scientific and technical input to the design of the protocols, coordinate and execute the clinical pharmacokinetic elements of the Phase I studies. Another key role is to oversee bioanalytical activities related to drug assay from development to regulatory submission.
- Effectively representing the department in cross functional teams to ensure integration of modern pharmacokinetic principles in designing the clinical pharmacology plan
- Perform pharmacokinetic non-compartmental and compartmental analyses and provide sound interpretation of the pharmacokinetic results
- Provide pharmacokinetic input and work collaboratively with study biostatisticians, medical writers, clinical trial managers, and representatives from Regulatory Affairs, in support of the phase I and proof of concept trials
- Responsible for the clinical pharmacokinetic-related section in documents, including clinical protocols, study reports; clinical pharmacokinetic components of investigator brochures, and regulatory documents
- Interacts effectively with members from various disciplines; serves as pharmacokinetic expert and liaises with partners on projects
- Ensures an adequate follow-up of studies and project timelines
- Facilitate establishment of contracts with CRO’s selected to perform bioanalytical analyses and manage budget, agreements, and timelines
- Manage bioanalytical activities for multiple studies across several programs and therapeutic areas
- Oversee assay development, validation, generation and completion of assay performance reports
- Coordinate input into clinical study documents such as the protocol, lab manual, CRFs, and data and bioanalytical report deliverable timelines
- Act as a subject matter expert at bioanalytical compliance and regulatory audits
PhD from an accredited college or university in clinical pharmacology, pharmaceutics, clinical pharmacokinetics or biopharmaceutics or closely related field and at least 8 year experience in the Pharmaceutical Industry working in clinical pharmacokinetics, bioanalysis, and drug metabolism.
- Demonstrated ability to successfully manage the clinical pharmacokinetic components of multiple drug products in early phases of development
- Demonstrated ability to successfully manage pharmacokinetic aspects of regulatory agency interactions
- Demonstrated ability to successfully interact with internal staff and manage external bioanalytical vendors
- Strong foundation in clinical pharmacokinetics and a detailed understanding of non-clinical and clinical DMPK processes; expertise in PK/PD and Population PK modeling is also desirable
- A sound working knowledge of the cross-functional interfaces that are important for efficient drug development
- A sound working knowledge of regulatory documentation requirements
- Ability to present complex issues in oral and written form
- 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
- Excellent interpersonal, communication, analytical, and organizational skills
- Proven ability to work within and motivate cross-function teams
- Ability to effectively present information to management, external contractors and employees at all levels of the organization
Serve as clinical pharmacokinetic and bioanalytical lead and drive the execution and implementation of all related activities from protocol concept to final report including interpretation of pharmacokinetic results. Create and maintain internal and external networks to preserve cutting edge knowledge in clinical pharmacokinetic and bioanalytical approaches. Represent and lead clinical pharmacokinetic and bioanalytical contributions to all regulatory documents. Work with clinical teams to ensure quality and timely deliverables. Maintain extensive scientific awareness that allow continuous improvement and resolution of emerging issues during the drug development.
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. Employee must occasionally lift and/or move up to 15 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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity