Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of MasterKey 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 therapy that targets a specific family of mutations, termed a MasterKey therapy.
Black Diamond Therapeutics is looking for an agile, self-motivated,and experienced individual to serve as the Senior Director/Director, Medical Writing to support clinical project teams to meet their clinical document deliverables. The successful candidate will be detailed oriented, self-directed and with the ability to be flexible and manage workload to meet project timelines.
- Rooted in a deep understanding of the project(s), the medical writer understands the key message(s) the document must convey and can analyze, interpret and distill data and other information to create documents with a robust argument.
- Understands the principles of scientific writing, writing with the audience in mind and conveying messages in a clear and concise manner.
- Applies advanced knowledge of relevant regulatory requirements and company policies as well as work experience to assess document requirements and identify information gaps or other potential issues.
- Innovative with problem solving and peer influence skills.
- Ability to collaborate with project teams, subject matter experts, and line management to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Flexible to roll up their sleeves to support the team as needed with writing needs.
- As a lead MW, coordinates review cycles of documents, managing all aspects of document development process and leads project teams through the process, including leading discussions on document revision, QC and finalization to resolve team comments.
- Responsible for the preparation of quality well-structured and formatted documents that follow the internal style guide and can be readily published and submitted through health authority gateways.
- Highly proficient in the use of internal systems, tools, and processes.
- Engages early with project teams and subject matter experts to plan and review tables, listings and figures for assigned documents.
- Writes or coordinates clinical and regulatory documents such as, but not limited to, CSRs, safety narratives, IBs, protocols, IND and NDA summary documents, responses to regulatory authorities, and briefing documents.
- Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality. Responsible for ensuring agreed upon document timelines and internal processes are followed. Interacts with cross-functional colleagues on document content and champions MW processes and best practices.
- Responsible for creating and maintaining document templates in collaboration with the VP of Regulatory Affairs and Functional Leads.
- Develops and maintains MW timelines and ensures timelines are aligned with overall regulatory and program timelines in collaboration with Regulatory Affairs, Project Management and the Functional Heads.
- Identifies areas for process improvements and possible solutions and communicates these to line management or appropriate functional line.
- Communicates medical writing's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
- Aligns with department management to set strategy for meeting department goals.
- External: May interact with or oversee day-to-day work by contractors or external service providers as needed. Produce documents in conjunction with vendors as needed.
- Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- Minimum of 5 years medical writing experience for a pharmaceutical or biotech is required. Experience in oncology is desired.
- Demonstrated track record writing in a clinical drug development or medical research at pharmaceutical/biotech environment. Deep personal experience in the writing of Protocols, Investigator Brochures, Briefing Documents, and other Regulatory documents.
- Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
- Experience producing high quality clinical and regulatory submission documents.
- Strong project management, organizational and prioritization skills for the management of multiple concurrent projects. Able to define realistic and detailed timelines and obtain cross functional input and agreement.
- Ability to manage documents of greater complexity and/or variety and to multi-task and work effectively under pressure
- Ability to work collaboratively with multifunctional teams and partners understanding the role of each team member of cross-functional teams
- Additional experience directly contributing to and/or supervising the writing of congress presentations and manuscripts is preferred.
- Experienced in resource planning and management experience with virtual teams. Ability to manage/mentor junior team members or contract writers.
- Available during Eastern Time working hours.
This job operates in a professional office environment. This role routinely usues 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.