Senior Clinical Scientist
Abide Therapeutics is seeking a highly motivated, experienced senior clinical scientist to contribute to the identification and development of novel small molecule drugs targeting the serine hydrolase enzyme family. Abide’s mission is to develop innovative medicines that target serine hydrolases, one of the largest enzyme classes in nature with validated, but mostly untapped therapeutic potential. Abide is a privately held biotechnology company. We have offices in San Diego, California and Princeton, New Jersey.
The correct candidate will join a small development group composed of two physician scientists, two senior clinical scientists who focus in early development, and a project manager.
If you thrive in a dynamic, fast-paced environment and enjoy creative and challenging work, Abide may be the company for you. We are currently seeking a Senior Clinical Scientist to join our team.
The successful candidate will be responsible for the support of Abide’s clinical programs in accordance with Good Clinical Practice (GCP), International Council on Harmonization (ICH) guidelines, federal regulations, and standard operating procedures (SOPs), and will participate in Abide cross-functional teams to ensure the effective delivery of project milestones. Specific responsibilities include:
- Manage, under the supervision of senior Abide clinical staff, the successful and timely execution of all operational aspects of clinical trial activities, including: planning of investigator meetings and safety review meetings; vendor management; tracking and monitoring of lab results, dosing compliance, and sample shipments; planning and reconciliation of clinical supplies
- Contribute to site feasibility and selection of qualified investigators and sites, and to selection and oversight of clinical vendors
- Oversee clinical study data management partners and serve as primary point of contact for data management communications for all assigned Abide studies
- Ensure regulatory documents and study supplies are maintained during the lifecycle of each study for all assigned Abide studies
- Oversee and maintain the Trial Master File for all assigned studies in accordance with Abide SOPs, GCP, and ICH Guidelines
- Oversee preparation, review, approval, and maintenance of Abide SOPs, including archiving and coordination of annual review process
- Coordinate and contribute to authoring of protocols, ICFs, IBs, related clinical trial documents (e.g., study-specific manuals/plans), study reports, and related regulatory submission documents (e.g., DSURs), under the supervision of senior Abide clinical staff
Experience and education requirements
- MS/PharmD/PhD in science, BS will be considered
- Knowledge of GCP as related to clinical trial management
- 1-3 years (Scientist) 3-5 years (Senior Scientist) of experience in site management and logistical execution of clinical trials within a pharmaceutical, biotechnology, and/or CRO setting
- Excellent oral and written communication skills
- Excellent problem-solving, troubleshooting, and organization skills
- Proficient with computers, business software such as Microsoft Word, Excel, PowerPoint
- Both an effective team player and a strong individual contributor, flexible, and able to prioritize multiple tasks and deliver high quality results under tight timelines
- Experience with data management
- Experience with clinical supplies
For additional information about Abide Therapeutics, Inc. please visit our website at www.abidetx.com. In addition to a competitive compensation package with stock options, Abide also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) Plan. For consideration, please submit your resume and cover letter referencing job SCS2018.12.03. Abide Therapeutics, Inc. is an EEO employer.