Director/Sr. Director, Data Management
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company’s proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations.
Black Diamond Therapeutics (BDTX) Senior Director role in Data Management is expected to perform a variety of clinical study delivery activities in support of our company’s senior-level leaders in Clinical Development/Clinical Operations.
This role oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, set up, maintenance, and close out. Manages the day-to-day data management of project activities including, but not limited to; timelines, budgets, project scope, reports and communication for the lifecycle of the project(s).Responsibilities
Under the direction of the VP of Clinical Operations the role must achieve successful delivery of data management deliverables, meeting internal and external Company needs.
- Oversees day to day data management project activities performed by the in-house team or by external vendors
- Works closely with other functions and serves as the primary Company liaison for data management issues
- Establishes, monitors and maintains timelines for data management responsibilities
- Participates in vendor selection for data management activities
- Oversees/manages direct reports providing direction and guidance on assigned tasks and employee development.
- Mentors and trains Data Managment members as needed.
- Develops, informs and drives departmental goals and SOPs as needed.
- Ensures Vendor Management Plans are in place for all DM vendors, as appropriate
- Ensures Data Transfer Agreements are put in place for each DM vendor in a timely fashion
- Develops a plan and oversees timelines for activities for each study, including but not limited to timelines leading to database lock
- Monitors project budget and project scope, as they relate to data management activities
- Ensures Clinical Trial Managers receive regular updates on project progress pertaining to data management activities from assigned team members
- Performs other duties as assigned
- Undergraduate degree in clinical, science, or health-related field from an accredited institution, or equivalent work experience required
- Advanced degree (e.g., M.S., M.B.A., Pharm.D.) preferred
- A minimum of 8 years of industry experience
- Prior experience in the contract research environment preferred
- Prior experience managing staff in Data Management
Knowledge, Skills and Abilities (language, technical, communication, etc.)
- Exceptional working knowledge of clinical trials and data management role in the clinical trials process
- Excellent organizational skills
- Outstanding leadership capabilities
- Highly effective communication skills, including oral and writing
- Previous experience driving Data Management related timelines, with particular focus on database locks
- SOP writing
- Technical skills will include industry standard clinical data management systems (e.g. Oracle Clinical, Phase Forward Inform, Medidata RAVE, , Datalabs, REDCap) and Excel.
- Additional skills may include any of the following:MS Project, involvement with a federal submission (either NDA or PMA), programming skills (SAS, PL/SQL) and analytical capabilities.
This job operates in a professional office and lab environment. This role routinely uses standard office equipment.
The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.
Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.