Job Summary

The Clinical Research Pharmacist is responsible for the set-up of clinical studies and for the receipt, storage, production, drug accountability and destruction of investigational medicinal products for Clinical Research Unit participants or patients, meeting regulatory requirements for preparation of dose formulations under Good Clinical Practices (GCP) for new chemical entities (NCE) and biologicals in accordance with applicable laws and regulations.

Job Responsibilities

Leads pharmacy projects for the preparation of both sterile and non-sterile customized extemporaneously prepared or manipulated drug product investigational drugs as well as solid dosage form dispensing. Develops ideas and leads/co-leads standard and complex pharmacy projects within clinical research pharmacy, pharmacy regulation. Creates an environment where pharmacy and technology innovation is the standard. Reviews preparation setup and completion work performed by preparation team. Maintains pharmacy compliance with all state and federal laws, and all applicable licensing and regulatory bodies, including but not limited to FDA, DEA, USP. Co-leads compounding development verification and optimized delivery of doses via novel processes in collaboration with formulators, analysts and QA. Provides after hours business support as needed and on a rotating schedule

Here Is What You Need (Minimum Requirements)

• Doctor of Pharmacy degree
• Minimum 2 years of pharmacy practice experience
• Minimum of 1 year of pharmaceutical industry experience
• Current license to practice pharmacy from the Connecticut Commission of Pharmacy. Multi-state licensure preferred
• Knowledge of pharmacy practice principles and comprehensive knowledge of principles within drug product formulation and development.
• Current BLS certification required
• Excellent verbal and written communication skills
• Ability to work independently
• Ability to build collaborative working relationships with colleague

Bonus Points If You Have (Preferred Requirements)

• Post-doctoral residency or fellowship
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

This role has office-based, pharmacy preparation and patient exposure environment requirements. As such, the role requires mental acuity to perform accurate complex pharmaceutical calculations and the ability to understand the implications of calculation errors (i.e., over dosing or under dosing research subjects). Additionally, in the clinical environment, candidate is required to understand the risk of exposure to blood borne disease. The role has moderate physical requirements and some travel (approximately 10%) is expected as needed in support of project needs.

PHYSICAL/MENTAL REQUIREMENTS

Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to wear full face respirator, face mask, and PAPR.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to work off-hours and on weekends as needed (most years may require 1-2 times); Ability to perform aseptic gowning requirements.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Research and Development