Black Diamond Therapeutics Inc

Head of Technical Operations

Job Locations US-MA-Cambridge
ID
2020-1038
Category
Clinical Development-Clinical Operations
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 Head of Technical Operations will be responsible for Black Diamond’s manufacturing & supply chain strategy, including CMC/early development, for all development programs in preparation for commercialization and in support of the Company’s corporate objectives and strategy.

 

Key aspects of the role include ensuring clinical supply for on-going clinical trials, building out manufacturing resources and capabilities, identifying and securing key supplier relationships, preparing for and supporting regulatory filings and interactions, and preparing for commercialization based on accelerated approval pathways.  The successful candidate enjoys the environment of an early-stage clinical biotech company and alternating between being “hands-on” and strategic.

Responsibilities

  • Plans and implements product manufacturing strategy through outsourced relationships ensuring adequate and timely supply of drug product for development programs and potential commercialization based on accelerated approval pathways.
  • Responsible for long-range strategic planning for manufacturing and supply chain operations; discusses and presents manufacturing plans/updates to the Executive team, the Board of Directors, and business partners, as required.
  • In coordination with Reg CMC, leads the implementation of the overall CMC strategy for clinical to commercial stage products ranging from strategic sourcing, tech transfer, process validation, clinical supply, and commercial supply manufacturing.
  • Negotiates and administers contracts with suppliers, and contract manufacturing organizations. Performs on-site visits as needed to key suppliers in North America, Asia, and Europe.
  • Selects and manages vendors to ensure compliance with product quality, regulatory requirements, manufacturing schedules and contract terms.
  • Develops long-term strategies to establish and maintain a robust commercial supply chain, enact appropriate risk mitigation procedures, and monitor and identify future market trends.
  • Ensures all manufacturing and process validation activities are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.
  • Prepares documentation, regulatory reports and technical papers including CMC sections of various regulatory filings.
  • Plans, coordinates, and directs programs for process development, and improvement of manufacturing processes.
  • Coordinates process research and analysis activities according to applicable government regulations, manufacturing processes, or other considerations, and approves modification of formulas, standards, specifications, and processes.
  • Reviews research, testing, quality control, and other operational reports to ensure that quality standards, efficiency, and schedules are met.
  • Provides chemistry and manufacturing expertise to product evaluation team members considering compounds for in licensing.
  • Advises and assists in obtaining patents for products, processes, or improvements.
  • Directly supervises existing CMC team and develops, oversees, and takes responsibility for manufacturing operational budgets and resource planning to meet market growth and associated business objectives. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; Addressing complaints and resolving problems.

Qualifications

 

  • Requires a BS in chemistry or engineering with an advanced degree preferred.
  • Requires at least 15 years of related experience in manufacturing and CMC activities within the Biotechnology or Pharmaceutical industry, with significant experience in the field of oncology drug development.
  • Leadership experience with supply chain, manufacturing development strategy and oversight, establishing improvement objectives, and delivering results within tight project deadlines.
  • Demonstrated ability to manage supplier relationships for clinical and commercial manufacturing, including relationship building, improvement of execution deliverables and contract negotiation.
  • Experience in overseeing manufacturing/labeling/packaging for global markets to support product launch and commercialization is required.
  • Experience in CMC activities from IND-enabling requirements to commercial-scale activities for small-molecule compounds.
  • Proven track-record leading CMC activities from first-in-human testing to scale-up and commercial launch.
  • In-depth knowledge about domestic and international regulatory requirements including experience interacting with applicable authorities.
  • Outstanding interpersonal verbal, written, and presentation skills in communication with internal and external colleagues and partners.
  • Strong analytical, decision-making, project management and problem-solving skills
  • Ability to navigate through ambiguity, rapid growth, and adapt to change
  • Ability to accommodate domestic and international travel at the request of the business (approximately 25-30%).

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.

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