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About Us:

Timberlyne Therapeutics  is a clinical-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for high unmet medical needs. Timberlyne’s lead program is CM313, an IgG1 monoclonal antibody with enhanced complement-dependent cytotoxicity that targets CD38. By targeting CD38, which is highly expressed on plasma cells, NK cells, and other immune cells, CM313 modulates multiple immune cell types leading to both rapid and durable responses across a range of autoimmune diseases and cancers.

 Position Summary:

Timberlyne is seeking a Clinical Trial Associate (CTA) to join the Clinical Operations team.  The Clinical Trial Associate will participate in planning and assisting in managing the conduct of clinical trials in accordance with company policies and procedures and applicable regulations.

This position is a key member of the Clinical Operations team, responsible for providing administrative and operational support throughout the duration of a clinical study.

Essential Responsibilities:

• Supports the Clinical Operations team under the supervision of the Clinical Program Manager.
• May contact clinical trial sites, vendors, CROs, and partners as needed.
• Performs administrative tasks to support clinical project teams.
• Maintains the Trial Master File (TMF).
• Prepares meeting agendas, meeting minutes, and tracking logs.
• Tracks clinical trial progress, including enrollment tracking, status update reports, and other reports as needed for assigned clinical trials.
• Submits applicable documents to the Trial Master File (TMF).
• Follows applicable Standard Operation Procedures (SOPs)
• Assists with the creation and maintenance of documentation for assigned clinical trials. Documents may include, but are not limited to presentations, pharmacy manuals, regulatory binders, lab manuals, and training materials.
• Partners with external vendors for accurate distribution of all clinical trial-related materials to clinical trial sites or clinical team members.
• Responsible for scheduling internal meetings and meetings with external collaborators and generating timely meeting minutes.
• Assists with creation and distribution of study-level communication to stakeholders.
• Supports the study team by proactively identifying, resolving, and/or escalating issues to assigned staff.
• Under general supervision collects, processes and tracks investigator sites and regulatory documents required by the FDA, and other regulatory authorities.
• Coordinates, processes, and tracks shipments (i.e., supplies, study-related materials, etc.)
• Serves as a point of contact for clinical supplies, document collection and preparation for close-out.
• Prepares and maintains documents and files such as clinical study files, regulatory binders, and operations manuals for clinical sites (i.e., informed consent form, protocol and investigators brochure).
• Assists with the quality review of documentation e.g., ICFs, regulatory green light packages.
• Capable of handling additional tasks with little supervision.

Skills and Experience:

• S. or B.A. in biological sciences, advanced degree preferred, with 2+ years of relevant industry experience.
• Ability to travel as required.
• Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Ability to establish and maintain effective working relationships with coworkers, managers, vendors, and clients.
• Excellent written and verbal communication skills.
• Significant attention to detail, time management and organizational skills with the ability to multi-task and prioritize.
• Ability to deal with time demands, incomplete information or unexpected events.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

How To Apply:  Please send your resume to careers@timberlyne-tx.com

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.