Associate Director, Medical Writing
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.
The BDTX Medical Writer role collaborates with cross-functional team members to develop high-quality clinical and regulatory documents (eg, clinical study protocols, Investigator brochures, clinical studyreport) and other related documents within the project timelines.Responsibilities
To be successful in the role, the individual must be able to perform the following:
• Prepares, edits, and finalizes clinical and regulatory documents.• Works in a collaborative manner with cross-functional partners (clinicians, clinical scientists, biostatisticians, pharmacokineticists, etc) to ensure study results and statistical interpretations are accurately and clearly reflected in documents.• Schedules and conducts document-related meetings, including kickoff and roundtable consolidation meetings. • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addresse• Works closely with the study team to ensure timelines are adhered to for deliverables.• Ensures that medical writing deliverables conform to ICH, FDA, and other relevant guidelines.• Develops documents in accordance with established standard operating procedures and work instructions.• Ensures the final version of documents are submission ready and are appropriately stored within the document management system.• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements.• Suggests or identifies changes, modifications, and/or improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity.• May manage external writers and QC specialists.• Aligns with the Head of Medical Writing to ensure the MW department achieves its goals.Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required.
The ideal candidate will have:• At a minimum: Bachelor degree (preference with a major in science). Post-graduate degree (Master’s or Doctoral degree preferred).• Relevant medical writing experience, with preference for those with experience writing documents related to oncology: Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years.• Knowledgeable regarding ICH/FDA regulatory guidance for clinical/regulatory documents.• Previous experience creating documents included in INDs and/or NDAs.• An understanding of the drug development process.• Ability to work on multiple projects at the same time.• Experience in interacting with cross functional study team members.
Knowledge, Skills and Abilities:• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing.• Ability to interpret TLFs and to summarize results in a clear and concise manner.• Ability to work independently with minimal supervision, multi-task, work effectively under pressure, and adapt to change as needed.• Possess project management skills with a high attentive to details.
This job operates in a professional office 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.