Associate Director/Director, Clinical Supply Chain

Location
Cambridge, MA, US
Posted
Nov 07, 2020
Ref
1055
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 Therapeutics, a clinical stage company, based in Cambridge Massachusetts is looking for an experienced clinical supply chain management professional to oversee all aspects of clinical supply management including forecasting, packaging, labeling, distribution, monitoring inventory, and vendor oversight.

Responsibilities
  • Develop and manage forecasts by creating and reviewing clinical supply demand for clinical trials
  • Work closely with Technical Operations and Clinical Operations teams to ensure timely labeling, packaging and distribution of clinical trial material
  • Ensure continuity of supply by establishing and monitoring an appropriate monthly forward inventory level and advising Clinical Operations team and study sites on inventory levels throughout the trials
  • Identify potential supply risks and develop preventive actions to avoid supply interruptions
  • Collaborate with external vendors to develop and approve specifications and user acceptance testing of IVR/IWR systems, while reviewing and modifying when study plans change
  • Review vendor-generated documentation and collaborate with Quality team to complete final review/approvals
  • Manage vendors and their respective contracts, invoice review, and budget planning
  • Establish workflows and SOPs in accordance with industry best practices

Qualifications
  • A degree in natural science, engineering, nosiness administration
  • A minimum of 6 years of clinical supply chain experience. APICS certification or coursework is preferred
  • Direct experience in planning and overseeing supply for double-blinded placebo-controlled, as well as, open label clinical studies
  • Forecast and manage supply needs and distribution
  • Knowledge of global practices governing pharmaceutical drug product manufacturing and conduct of routine clinical trials distribution
  • Clinical supply management including forecasting, labeling, packaging, distribution, expiries, inventory tracking, and managing IRT systems
  • Knowledge of US, EU, and rest of the world clinical supply labeling requirements is required. Knowledge of QP review process for European clinical supplies is preferred
  • Experience with both ambient and cold chain products is preferred


Work Location:

The role will be based in our Cambridge office.

Work Environment:

This job operates in a professional office environment. This role routinely uses 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.

Incumbent's Name: _______________________________

Signature: _______________________________ Date: ___________