Sr. Manager/Associate Director/ Director, Non-Clinical Operations

Location
Cambridge, MA, US
Posted
Mar 15, 2021
Ref
1068
Hotbed
Genetown
Required Education
Bachelors Degree
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-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.

Black Diamond is currently seeking a Nonclinical Operations lead to become an integral member of the Nonclinical Development function. This versatile, self-motivated individual will play an instrumental role in organizing and maintaining an efficient operating environment for project-related Nonclinical Development activities, and by establishing and executing on overall program plans. We are looking for a consummate team player who seeks a scientifically rigorous and collaborative environment in which to grow their career in drug development.

Responsibilities

Primary Responsibilities:
  • In partnership with Nonclinical leads and project leaders, develop program goals and timelines for Black Diamond's late discovery and development programs
  • Day-to-day oversight and management of Nonclinical activities, including project planning and timeline tracking, sample management, study logistics, and CRO management
  • Oversee process for legal contracts (CDAs, MSAs, SOWs), in close collaboration with Legal
  • Ensure coordination of activities and deliverables across DMPK, Toxicology and Clinical Pharmacology functions as well as cross-functionally, including collaboration with Project Management
  • Manage the Nonclinical budget, including raising POs and resource tracking
  • Manage and oversee documentation and data management/archiving for Nonclinical
  • Contribute to building and maintaining Quality infrastructure through the authoring, review and management of SOPs, protocols, etc.
  • Manage CROs and other vendors, including periodic travel to CROs

Qualifications

Qualifications:
  • 7-10+ years of relevant biotech and/or pharmaceutical industry experience is required
  • Undergraduate or advanced degree in a scientific discipline
  • At least 4-5 years in Nonclinical Operations is required
  • Experience managing projects across discovery and preclinical programs; experience managing cross functional activities through IND submission preferred
  • Operational experience and familiarity with the drug development process, including function-level activities and external regulatory requirements. Good working knowledge of GLP.
  • Excellent communication skills; comfortable navigating complexity and ambiguity in a fast-paced environment
  • Excellent organizational skills with knowledge of project management tools (e.g. Microsoft Project)


Work Environment:

This job operates in a professional office environment with travel activities of approximately XX% 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.