Sr Clinical Drug Delivery (Investigational Product) Specialist
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries.
Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable until now.
We don t follow footsteps.
We create the path.
Primary Duties
The Sr Clinical Drug Delivery (Investigational Product) Specialist will develop administration protocols and site pharmacy training materials in support of clinical trials, as well as post-marketing product handling and preparation training for Treatment Centers.
The individual will author and review documents related to clinical administration and handling of Spark products.
S/He will work with internal and external customers to accomplish project objectives, develop systems to manage clinical supplies, and ensure clinical supply and training readiness at clinical sites.
The individual will also serve as a subject matter expert on drug product handling, preparation, and formulation as it relates to the clinical setting.
Responsibilities
% of Time
Job Function and Description
70%
Clinical trial logistics
Responsibilities:
-Author and review clinical documents including trial protocols and pharmacy brochures
-Develop educational materials and perform pharmacy trainings at sites to ensure proper handling and dosing of investigational products
-Work with Clinical Operations and Clinical Development to support dose calculations, delivery of investigational product, and training of sites
-Develop/review IP preparation protocols
-Align with Clinical Supply to support timely shipping to US and international sites, coordinating logistics and material needs with appropriate departments
-Develop and utilize clinical management systems including Interactive Response Technologies (IRTs) to ensure efficient distribution of IP, supplies, and supportive medications
-Act as a resource to clinical sites, responding to pharmacist questions and observing preparations
-Conduct pharmacy/investigational product trainings during Investigator meetings; attend investigator phone calls; interact with sites regarding questions related to investigational product and handling
-Review and update SOPs
-Participate in cross-functional team meetings
20%
Regulatory Support:
-Provide input/assist with device compatibility studies in support of regulatory filings; author protocols and reports
-Author and review drug product sections of regulatory documents
-Respond to questions from regulatory agencies related to drug product handling and preparation
10%
Support Launch of Marketed Products at Treatment Centers
-Review and edit preparation protocols and Pharmacy Manuals
-Develop training materials and perform pharmacy educational sessions
-Observe preparations at Treatment Centers
-Serve as a resource to Treatment Centers regarding product handling and preparation
Other duties as assigned
Education and Experience Requirements
- Bachelor s degree in a scientific discipline or equivalent; advanced degree (MS, PhD, PharmD) preferred
- Minimum of 5 years of pharmaceutical industry or compounding pharmacy experience; experience with vaccines, viral vectors, or AAV is a plus
- Experience with handling of biologics
- Experience working with third-party vendors, CROs, or CRAs
- Knowledge of USP 797, USP 800, and CFR
- Knowledge of GCP, GMP, and applicable regulations
- Proficient in Microsoft Office applications
- Requires domestic and international travel (approximately 25%)
Key Skills, Abilities, and Competencies
- Understanding of drug development process and clinical trial design
- Ability to communicate effectively both orally and in writing with internal and external partners; excellent presentation skills required
- Capable of representing Spark professionally with external global investigators, vendors, regulatory agencies, alliance partners, and others
- Able to effectively engage with investigative sites and personnel
- Ability to work effectively cross-functionally, and to serve as a resource within Spark
#LI-JW1
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Estimated Salary: $20 to $28 per hour based on qualifications.
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