Senior Manager/Associate Director, Clinical Data Management

Timberlyne Therapeutics • San Francisco, CA

2d

About The Position

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 Program Manager (CPM) to join the Clinical Operations team. This individual will be responsible for the management of global clinical programs. They will lead the study team, vendors, clinical monitors and clinical sites throughout the life cycle of a clinical program. This individual will be able to manage multiple study teams across a program and have broad involvement in work central to Timberlyne’s strategic goals. They will apply existing technical skills, learn new skills, and play a key role in the development of the programs and help grow the company and guide its direction. CPM is responsible for the successful implementation of a clinical program, including providing mentorship and oversight of all aspects of global clinical trials within designated program budgets and timelines. Experience in leading staff as well as mentoring and developing junior staff will be essential to the team’s success. The CPM will represent Clinical Operations at Project team meetings and may represent Timberlyne at professional events.

Requirements

• BS. or B.A. in biological sciences, advanced degree preferred with 8+ 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 in leading teams, including CROs, consultants and vendors.
• Proficient in developing trial plans and implementing operational changes across multiple studies
• Highly developed leadership skills to successfully lead multiple direct reports
• Must display strong analytical and problem-solving skills at a program level and collaborate with colleagues to generate solutions
• Strong communication and influence skills and ability to create a clear sense of direction
• 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

Responsibilities

• Accountable for all operational aspects of clinical trials within the assigned program
• Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
• Examine functional issues from a broader organizational perspective and develop a strategy to implement with a cross-functional team
• Provides oversight to vendors, including CRO, central lab, EDC/IRT systems, etc.
• Proactively identifies potential issues/risks across the program and recommends/implements solutions.
• Participates in the selection, training and evaluation of clinical trial managers and clinical trial management associates to ensure the efficient operation of the function.
• Attends and presents at cross-functional meetings as needed to represent Clinical Operations and program level items
• Provides mentorship and career development to direct reports.
• Provides leadership to the clinical operations team working on the assigned program.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager