Director, Clinical Pharmacology
Director, Clinical Pharmacology
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Salary Not Disclosed
1 Vacancy
Job Description
Position Summary
The Director of Clinical Pharmacology will play a pivotal role in driving Acadias early development strategy across multiple therapeutic areas with a strong emphasis on neuroscience. This strategic and hands-on leader will shape and execute early-phase clinical pharmacology programs translating nonclinical findings into meaningful clinical outcomes. As a key member of cross-functional Asset Teams the Director will be responsible for the design and execution of Phase 1 studies including First-in-Human (FIH) food effect drug-drug interaction (DDI) and proof-of-concept (PoC) trials in healthy volunteers.
This role demands deep scientific expertise regulatory fluency and cross-disciplinary collaboration to inform data-driven decisions and enable seamless progression from discovery to clinical validation. The ideal candidate will bring a proven track record in designing and delivering early development strategies including biomarker and pharmacodynamic endpoint integration with the ability to influence program direction and regulatory submissions.
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.
- Perform 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.
Key Skills:
- 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.
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Required Experience:
Director
Employment Type
Full Time
