Careers

« Back to careers

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 CTM/Senior CTM to join the Clinical Operations team.  This individual will be responsible for the execution of global clinical studies. Reporting to the Clinical Program Manager, they will work closely with the study team, vendors, clinical monitors and clinical sites throughout the life cycle of the study.

This individual may be required to manage multiple studies and contribute to work central to Timberlyne’s strategic goals. They will apply existing technical skills, learn new skills, and play a key role in the execution of studies to help grow the company.

The CTM is responsible for the successful implementation of a clinical study or studies, including executing on all aspects of global clinical trials in line with budgets and timelines.

 Essential Responsibilities:

• Accountable for executing all aspects of the clinical trial(s) within the assigned program.
• Provides guidance and oversight for the successful execution of all aspects of international clinical trials within designated program budgets and timelines.
• Work closely with vendors, including CRO, central lab, EDC/IRT systems, etc.
• In conjunction with the CPM, proactively identifies potential issues/risks across the study and implements solutions.
• May be required to attend and present at cross-functional meetings as needed to represent Clinical Operations relative to study level items.

 Skills and Experience:

• S. or B.A. in biological sciences, advanced degree preferred with 5+ years of relevant industry experience.
• Ability to travel as required for the program (10-15%).
• Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines.
• Experience working with CROs, consultants and vendors.
• Proficient in executing trial plans.
• Strong analytical and problem-solving skills at a study level to collaborate with the CPM on problem solving and solutions.
• Strong communication and influencing skills.
• Ability to deal with time demands, incomplete information or unexpected events.
• Outstanding organizational skills with the ability to multi-task and prioritize.
• 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.