Senior Director, Head of Clinical Medical Writing

Location
Cambridge, MA, US
Posted
Feb 06, 2021
Ref
1080
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

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-AllosteryPharmacology, 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 Clinical Development team at Black Diamond Therapeutics is looking for an agile, self-motivated,and experienced individual to serve as the Senior 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.

Responsibilities
  • Provides Medical Writing leadership for all assets from pre-IND to NDA.
  • Acts as a medical writing subject matter expert and works with clinical development team to deliver on medical writing program goals.
  • Oversee, and potentially contribute directly to, the development of a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, IND and NDA and other regulatory submissions documents.
  • Oversee, and potentially contribute directly to, the development of publications/presentations of emerging clinical data for Congresses, and/or other external stakeholders.
  • Oversee, and potentially contribute directly to, the development of manuscripts summarizing the emerging clinical data.
  • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
  • Oversee, or directly contribute to, the planning, process and coordination timelines to ensure timely completion of clinical writing projects.
  • Manage timelines and communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables.
  • Provide support for QC of complex clinical documents.
  • Ensure that the key messages in protocols, publications, presentations and regulatory documents align with each other, and also with the Investor Relations documents.
  • Ensures that the Medical Writing department is fully resourced to manage the workload for multiple clinical and pre-IND assets. This will include roll-up-your-sleeves personal contribution, bringing in (and supervising) consultants, as well as building an in-house organization.

Qualifications
  • Minimum of bachelor's degree or equivalent in scientific or medical discipline; Advanced degree preferred.
  • Minimum of 10 years medical writing experience for a pharmaceutical or biotech is required.
  • Experience supervising other medical writers (whether in an Agency, consultants and/or full-time employees). Experience building teams is preferred.
  • Deep personal experience in the writing of Protocols, Investigator Brochures, Briefing Documents, and other Regulatory documents.
  • 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, employees based in field locations, and functional service providers.
  • 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 and organizational skills.
  • Strong organizational/prioritization skills for the management of multiple concurrent projects.
  • Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches.
  • Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes.


Work Environment:

This job operates in a professional office environment. This role routinely usues standard office equipment.

Physical Demands:

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.