Clinical Scientist (Contractor)

Location
Cambridge, MA, US
Posted
Feb 12, 2021
Ref
1083
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Contract
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.

We are seeking a Clinical Scientist to play a pivotal role in supporting key oncology programs. This position will report to the VP, Clinical Operations. The Clinical Scientist will be responsible for providing scientific support for all clinical development activities.

Responsibilities
  • May involve contributing to the development of clinical strategies and trial execution.
  • Development of protocols for clinical studies.
  • Provide support as needed for scientific issues that may arise during study execution.
  • Collaborate with the Clinical Operations group to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol safety, Case Report Forms (CRFs), etc.
  • May involve developing relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
  • May act as a clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
  • May involve serving as liaison to project teams, CRO's, Clinical sub-teams, and others.
  • Maintain updated knowledge of competitive landscape in regard to assets with similar MOA and/or evolving standards of care for indications of interest.
  • Collaborate with the Regulatory group in the drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, CSRs and other FDA submissions, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.
  • Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature.
  • Understand and support creation of competitor landscape, medical need, regulatory strategy.
  • Perform literature searches and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
  • Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied.
  • Write abstracts and present data at scientific meetings, both internally and externally.
  • Contribute positively to a strong culture of business integrity and ethics.
  • Act within compliance and legal requirements as well as within company guidelines.

Qualifications
  • Advanced degree (e.g., MS, PhD, PharmD).
  • Minimum of 10 years of experience in a pharmaceutical industry or CRO environment in drug development.
  • Prior oncology drug development experience is required.
  • Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
  • Proven track record of working with investigators, site staff, external experts, Contract Research Organizations, and vendors.
  • Demonstrated ability to work in matrix teams and in a fast-paced environment.
  • Excellent management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams.
  • Strong analytical ability.
  • Excellent interpersonal and decision-making skills.
  • Ability to work independently and enthusiasm to deliver the program objectives in a timely manner. Negotiation and influential skills are advantageous.
  • Ability to lead, coach and train more junior team members within the function.
  • Demonstrated ability to comprehend complex scientific concepts and data.
  • Proficient in reviewing and assessing clinical data.


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.