Executive Director, Clinical Development (EDCD)

Job Description

Metacrine is a dynamic, clinical-stage biotech company headquartered in San Diego, CA. The company is focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases.

We are looking for an Executive Director of Clinical Development (EDCD).  This highly motivated individual will report to the Chief Medical Officer and be a key member of the clinical and development teams. In addition to leading the planning and execution of clinical trials, the EDCD will maintain external collaborations with Key Opinion Leaders (KOL) and provide input for relevant documents such as Clinical Protocols, Investigator Brochures, Clinical Trial Applications and IND filings.

Key Responsibilities

  • Lead developer of clinical trial protocols, study reports, and relevant regulatory/ethics committee documents
  • Joint responsibility with clinical operations in selecting and managing contract research organizations (CROs) and other study vendors
  • Planning and managing advisory boards, investigators meetings, and other clinical/scientific events
  • Development and execution of clinical data communication/publication plan
  • Collaboration with pre-clinical colleagues to assess the need for and design of appropriate preclinical experiments to support the development plan
  • Analyses of development strategies and options for discovery pipeline programs

Requirements 

  • MD or PhD in a field related to biomedical research
  • 10+ years in clinical science/research/development, with 3+ years in a start-up biotech environment
  • Prior therapeutic experience in liver, GI or metabolic diseases a plus
  • Prior success in clinical trial design, data analysis, interpretation and clinical relevance
  • Knowledgeable with FDA and EMA regulations, Good Clinical Practice, and ICH guidance
  • Clear and precise verbal, presentation, and writing skills
  • Proven ability to work collaboratively in a fast-paced, matrix environment
  • Track record of creative problem-solving
  • Ability to “roll up your sleeves” and individually contribute to specific timelines and goals
  • Able to travel in U.S. and international up to 20% of the time

To apply for this position please submit a resume to careers@metacrine.com naming the position in the subject heading.

Executive Director, Clinical Operations (EDCO)

Job Description

Metacrine is a dynamic, clinical-stage biotech company headquartered in San Diego, CA. The company is focused on building an innovative pipeline of drugs to treat liver and gastrointestinal (GI) diseases.

We are looking for a highly motivated individual to lead Clinical Operations. Reporting to the Chief Medical Officer, the Executive Director of Clinical Operations (EDCO) will provide strategic leadership of all clinical operations activities at Metacrine. Additionally, the EDCO will manage and foster the growth of the clinical operations group.

Key Responsibilities

  • Support and supervise the activities of direct reports in trial conduct
  • If appropriate, assume lead operational role in select studies
  • Identify and resolve clinical operations issues related to data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, and review of trial master files
  • Partner with clinical development scientists/physicians to ensure successful data collection, analysis, and reporting
  • Proactively manage trial timelines and budgets to ensure that studies are completed on-time and within budget
  • Ensure compliance of clinical study sites to protocols and applicable regulations

Requirements 

  • Bachelor’s degree in a field related to biomedical research
  • 10+ years in clinical operations/development, with 3+ years in a start-up biotech environment
  • Prior therapeutic experience in liver, GI or metabolic diseases a plus
  • Knowledgeable with FDA and EMA regulations, Good Clinical Practice, and ICH guidance
  • Proven ability to work collaboratively in a fast-paced, matrix environment
  • Established track record in CRO/vendor management, including timeline/budget management and d negotiation skills
  • Managerial experience in recruiting, motivating and mentoring the growth of clinical operations team members
  • Ability to “roll up your sleeves” and individually contribute to specific timelines and goals
  • Able to travel in U.S. and international up to 20% of the time

To apply for this position please submit a resume to careers@metacrine.com naming the position in the subject heading.

DMPK Research Associate/Scientist

Job Description

Metacrine is a clinical-stage biopharmaceutical company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal diseases. Our most advanced program is focused on the farnesoid X receptor (FXR) an important drug target in multiple liver and GI diseases. Beyond our FXR program, we are building a pipeline of novel drug candidates by taking advantage of our drug discovery and development capabilities.

We are looking for a motivated, flexible, highly productive individual who is seeking a dynamic fast-paced biotechnology environment. This individual will join the DMPK team will interact extensively with the research and development team.

Key Responsibilities

  • Design and execute preclinical in vitro ADME studies to understand the ADME and PK characteristics of NCEs, and analyze and interpret the results with minimal direction from supervisor
  • Operate, maintain and troubleshoot triple Quad, QTRAP, HPLC/UPLC systems, auto sampler and data software systems, and perform and/or manage bioanalytical assay method development, characterization and validation
  • Manage multiple tasks/projects simultaneously to meet timelines and maintain a high level of productivity

Qualifications

  • MS degree (> 5 years) or BS degree (> 10 years) equivalent in drug metabolism or related discipline with relevant industrial experience in drug discovery/development
  • A strong theoretical and practical understanding of in vitro ADME assay principles and technologies including Bioanalysis is required.
  • Proficiency in operating and trouble-shooting HPLC-tandem Mass spectrometer (LC-MS/MS) is required.
  • Prior experience in LC-MS method development for separation and structural identification of multiple metabolites from various matrices would be a plus.

Applicants will not be considered without a cover letter highlighting recent industry experience and a list key DMPK techniques/procedures for which they are proficient.

To apply for this position please submit a resume to careers@metacrine.com naming the position in the subject heading.