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Principal Scientist

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Black Diamond Therapeutics

Location: Cambridge

Posted on: September 12, 2020

Job Description:

National Postdoctoral Association Career Center Black DiamondTherapeutics is a precision oncology medicine company pioneeringthe discovery and development of small molecule, tumor-agnostictherapies. Black Diamond targets undrugged mutations in patientswith genetically defined cancers for whom limited treatment optionscurrently exist. Black Diamond is built upon a deep understandingof cancer genetics, protein structure and function, and medicinalchemistry. The Company’s proprietary technology platform,Mutation-Allostery-Pharmacology, or MAP, platform, is designed toallow Black Diamond to analyze population-level genetic sequencingdata to identify oncogenic mutations that promote cancer acrosstumor types, group these mutations into families and develop asingle small molecule therapy in a tumor-agnostic manner thattargets a specific family of mutations.

Black Diamond is currently seeking a Toxicology project leadwith postgraduate training in toxicology or related discipline andpreferably board-certified in general toxicology (DABT) and/orpathology (DACVP). Reporting to the VP Preclinical Development, theincumbent will be the toxicology and safety pharmacology lead onproject teams developing small molecule modulators as precisioncancer medicines. We are looking for a consummate team playerseeking a collaborative environment in which to grow their careerin drug development.

Key Duties & Responsibilities:

In partnership with functional/project leaders, set thepreclinical/regulatory toxicology strategy and plans for BlackDiamond’s programs in late discovery and early development.

Establishment and oversight of activities at CROs, includingnon-GLP pilot toxicity studies and GLP toxicology studies tosupport the development of multiple drug candidates.

Be the functional area representative for Toxicology on projectteams; collaborate with medicinal chemistry and CMC to ensuresynthesis, formulation, and delivery of test articles for use intoxicology studies. Collaborate with DMPK in the design andintegration of DMPK activities into toxicology studies.

Design, analyze, and interpret preclinical toxicology studies insupport of program goals.

Author and review study reports and prepare relevant sections ofregulatory documents, including pre-IND packages, INDs, clinicaltrial applications (CTAs), Investigator Brochures, special protocolreviews, regulatory Briefing Documents, and NDAs/MAAs.

Requirements

An advanced degree and 5-10+ years of experience in thebiotech/pharmaceutical industry, with a focus on toxicology,pathology, safety pharmacology, or related discipline. DABT orDACVP preferred.

Previous experience in managing nonclinical toxicology/safetyprograms, and design, execution, and regulatory reporting of GLPtoxicology and safety pharmacology studies are required. Experiencein drug development and regulatory submissions, including IND/CTA,is desired.

Technical depth and a broad understanding of preclinical safetyassessment, preferably with experience in oncology.

Experience leading Toxicology programs on projects from latediscovery through development.

Operational experience and familiarity with the drug discoveryand development process, including external regulatoryrequirements. Well versed in authoring and reviewing nonclinicalsections of regulatory dossiers.

Proficient in the management of activities at contract researchorganizations and comfortable working in a virtual outsourcedmodel.

Excellent communication and organizational skills; comfortablenavigating complexity and ambiguity in a fast-paced environmentinteracting with consultants, external vendors, and internalcross-functional, global project teams.

To Apply:

Please forward applications via email only tocareers@bdtherapeutics.com including a cover letter and resume. Inthe e-mail subject line, please indicate the position title ofPrincipal Scientist, Toxicology.

Black Diamond Therapeutics is an equal opportunity employer andwelcomes and encourages all applications. Diversity and inclusionare important to core values and will encourage our creativity andgrowth as a company.

Job Information

Job ID: 54317257

Location:

Cambridge, Massachusetts, United States

Company Name: Black Diamond Therapeutics

Job Function: Product Safety

Job Type: Full-Time

Job Duration: Indefinite

Min Education: Master's Degree/Equivalent

Min Experience: 5-10 Years

Required Travel: 0-10%

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Keywords: Amazon Workforce Staffing, Cambridge , Principal Scientist, Other , Cambridge, Massachusetts

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