ABOUT THE ROLE

The Vice President, Clinical Operations leads the Clinical Operations capability, providing strategic input, guiding infrastructure development, and delivering on the execution of clinical trials at Chroma. We are moving rapidly toward the first clinical trials of our epigenetic editors and this role will be responsible for building and leading our clinical operations function to support successful trials. The Vice President, Clinical Operations will demonstrate a robust blend of leadership, operational expertise, vendor management, and cross-functional collaboration.

Clinical Operations Leadership

• 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

Vendor & CRO Management

• 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

Compliance And Risk Management

• 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

Budget & Resource Management

• 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

SKILLS & COMPETENCIES:

• Impactful leadership skills; conveys a sense of purpose, ownership, and urgency as a collaborative, positive, and decisive leader​
• Demonstrated ability to build and lead a new functional team at Chroma
• Broad and deep understanding of the drug development process and associated operational experience
• Ability to thrive in a fast-paced, innovative, and dynamic environment while remaining flexible, proactive, and resourceful
• High degree of organizational awareness and aptitude and an understanding of change management​ needs
• Partners, influences, motivates, and inspires with an ability to effectively resolve potential conflicts within a cross-functional matrix team structure
• Strong interpersonal, communication, and influencing skills for bridging between scientific and business participants, for negotiating timelines, and for effective collaboration
• Excellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
• Passionate, adaptable, and keen on working in the fast-paced biotech startup space to drive cutting-edge science

QUALIFICATIONS:

• 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