Full-Time

Vice President

Clinical Operations

Posted on 11/5/2024

Chroma Medicine

Chroma Medicine

51-200 employees

Develops single-dose genomic medicines using epigenetics

Biotechnology
Healthcare

Senior, Expert

Boston, MA, USA

Category
Healthcare Administration & Support
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Google Cloud Platform
Requirements
  • Bachelors in life or health care sciences; advanced degree preferred
  • Preference for 12+ years’ experience in the pharmaceutical or biotechnology industry as member of teams delivering complex therapeutics to patients with at least 5+ years’ experience in multi- or cross-functional leadership
  • In-depth understanding and experience across the clinical operations value chain with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
  • Experience with feasibility analysis for clinical site selection including patient distribution, estimation of recruitment rate, and practical evaluation of site capabilities
  • Therapeutic experience in genetic medicines, coupled with experience from early phase through pivotal, global multi-site clinical trials is highly desirable
  • Problem solving in challenging clinical studies required, working knowledge of GCP/ICH, GDPR (General Data Protection Regulation), clinical trial design, regulatory, and clinical development processes
Responsibilities
  • Establish vision and strategy for clinical operations capabilities at Chroma, including growing a core team supporting initial Phase 1 studies to planning for expanded efforts as the company grows.
  • Develop the strategy and oversee execution of Chroma’s initial first in human study evaluating CRMA-1001, an epigenetic editor for the treatment of chronic hepatitis B.
  • Build and lead a team of clinical operations professionals, providing mentorship and development opportunities
  • Oversee and manage all clinical trials ensuring alignment with global clinical development strategies; establish and execute processes to track timely execution of studies through metrics and analytics
  • Ensure effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols
  • Collaborate with cross-functional teams including medical, regulatory, legal, and future commercial departments
  • Keep abreast of competitive regulatory and clinical practices and utilizes this knowledge during the ongoing development and adjustment of plans; mentor clinical operations team on the Regulatory Inspections process and develops a pro-active approach for Inspection readiness in partnership with Quality Assurance colleagues
  • Build infrastructure including developing Chroma SOPs where needed to supplement those used from selected CRO
  • Manage relationships with CRO partners and their FSP models, vendors, and third-party partners involved in clinical trial execution ensuring alignment with global outsourcing strategies
  • Ensure vendors deliver high-quality, timely, and cost-effective services that meet project and organizational goals; establish key performance indicators (KPIs) and oversee vendor performance metrics, managing any issues or escalations as needed
  • Develop and maintain strong relationships with CROs, academic partners, and advocacy groups to ensure effective execution of clinical programs
  • Ensure all clinical trials comply with local regulatory and ethical requirements
  • Ensure trials are conducted in accordance with applicable regulatory requirements, ICH-GCP guidelines, and company SOPs.
  • Implement and maintain robust risk management strategies, identifying and mitigating operational risks related to clinical trial execution
  • Oversee quality assurance and audit processes for clinical trials
  • Develop and manage budget for clinical operations, ensuring cost-effective use of resources; forecast resource needs and work closely with program teams to ensure appropriate staffing and funding levels
  • Effectively review, negotiate, and oversee budgets with CROs and other vendors for clinical trials
  • Provide strategic view on operational planning, direction and delivery aligned to corporate goals
  • Provide strong input to the program teams in all aspects of ideation, planning, and delivery of clinical programs

Chroma Medicine develops single-dose genomic medicines that utilize epigenetics to regulate gene expression. By altering the structure of chromatin, the material that carries DNA, the company aims to create lasting changes in how genes are expressed without modifying the DNA sequence itself. This method has the potential to lead to new treatments for various diseases. Unlike many competitors, Chroma Medicine focuses on a unique approach to gene regulation, which could open new avenues in genomic therapeutics. The goal is to advance the field of genomic medicine and provide effective therapies for patients, while also expanding their research and development capabilities.

Company Stage

Series B

Total Funding

$252.9M

Headquarters

Boston, Massachusetts

Founded

2021

Growth & Insights
Headcount

6 month growth

-10%

1 year growth

-10%

2 year growth

64%
Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with Whitehead Institute enhances Chroma's epigenetic editing capabilities.
  • Jenny Marlowe's appointment could accelerate transition to clinical trials.
  • Successful preclinical results in PCSK9 reduction expand their cardiovascular therapeutic portfolio.

What critics are saying

  • Departure of key executive Kaplan may indicate potential leadership instability.
  • Recent layoffs suggest possible financial challenges or strategic pivots.

What makes Chroma Medicine unique

  • Chroma Medicine uses epigenetic editing to regulate gene expression without altering DNA.
  • Their CHARM technology offers precise gene silencing, enhancing therapeutic potential.
  • Chroma's single-dose approach aims for durable treatment effects, setting them apart.

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