Black Diamond Therapeutics Inc

Medical Director/ Sr. Medical Director, Clinical Development

Job Locations US-MA-Cambridge
ID
2020-1036
Category
Clinical Development
Type
Regular 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-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 Medical Director will be responsible for clinical research activities pertaining to Black Diamond's lead clinical asset, BDTX-189 as well as future clinical candidates as they move from discovery into IND-enabling activities. The Medical Director will engage relevant scientific/medical experts and key opinion leaders in order to manage clinical data generation from company-sponsored trials and other sources with the goal of obtaining regulatory approval for patients with an unmet medical need.

The ideal candidate will be a medical oncologist or equivalent with a proven track-record in leading targeted therapy clinical protocols in patients with relevant solid tumors.  The role will have the opportunity to contribute on the clinical development of novel drug candidates intended to treat patients in a tumor agnostic fashion. 

Responsibilities

Key Responsibilities:

  • Collaborate with internal stakeholder in discovery, preclinical and clinical development and other relevant functions as well as external experts, as necessary, to develop and execute clinical trials from first-in-human to registration according to corporate timelines.
  • Assume medical responsibility of ongoing and planned clinical trials. This includes real-time medical monitoring such as patient eligibility assessment, safety and efficacy assessment, address study design and protocol procedure questions.
  • Perform single-case and aggregate safety review in collaboration with CRO according to safety monitoring plans.
  • Assess expectedness of SUSARs to determine expedited regulatory reporting.
  • Analyze, interpret and present clinical data. This includes collaboration with investigators on publications of abstracts, posters, and manuscripts.
  • Participate in writing of clinical study protocols, Investigator's Brochures, clinical study reports, and other relevant controlled documents.
  • Participate in writing of relevant documents and sections for INDs and NDAs as well as responding to questions from regulatory authorities and IRBs/ethics committees.
  • Represent Black Diamond Clinical Development at scientific meetings, advisory boards and other outreach, as needed.

Qualifications

Experience & Qualifications:

  • MD (or equivalent) with successful academic or medical practice experience. Board certification or eligibility in medical oncology highly desired.
  • At least 4-5 year of clinical drug development experience leading oncology clinical trials within biotechnology or pharmaceutical industry. Similar relevant experience in academia may be considered.
  • Strong knowledge of clinical drug development activities in patients with solid tumors and knowledge of the regulatory requirements domestically and ideally internationally.
  • Strong knowledge of personalized/precision medicine including utility of relevant biomarker selection strategies, novel study design and stratification options. Should have basic knowledge of companion diagnostic requirements.
  • Personal and professional relationship with relevant investigators and key opinion leaders in the medical oncology community.
  • Strong knowledge about relevant GCP and ICH requirements and FDA regulations.
  • Must be able to meet deadlines in a fast-paced quickly changing environment.
  • A proactive approach to problem-solving with strong decision-making skills.
  • Professional level verbal and written communications skills.

 

Work Environment:

This job operates in a professional office environment with travel activities of approximately 20-30% of the time. 

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed