Chroma Medicine
Vice President, Clinical Operations
Chroma Medicine, Boston, Massachusetts, us, 02298
Chroma Medicine is pioneering a new class of genomic medicines that harness epigenetics, nature's innate mechanism for gene regulation, to deliver precise, programable single-course therapeutics while preserving genomic integrity.
Founded by the world's foremost experts in genomic medicine and backed by industry-leading investors, Chroma is working at the cutting edge of precision genetic medicine, building an entirely new class of therapeutics that can precisely and durably control gene expression without changing or cutting the underlying DNA sequence. Chroma is rapidly advancing novel epigenetic editing therapeutics to patients who are living with serious diseases.
We are hiring at our Boston, Massachusetts site, offering a unique opportunity to be part of our foundational Chroma team.
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 opportunitiesOversee 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 analyticsEnsure effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocolsCollaborate with cross-functional teams including medical, regulatory, legal, and future commercial departmentsKeep 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 colleaguesBuild infrastructure including developing Chroma SOPs where needed to supplement those used from selected CROVendor & 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 strategiesEnsure 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 neededDevelop and maintain strong relationships with CROs, academic partners, and advocacy groups to ensure effective execution of clinical programsCompliance And Risk Management
Ensure all clinical trials comply with local regulatory and ethical requirementsEnsure 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 executionOversee quality assurance and audit processes for clinical trialsBudget & 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 levelsEffectively review, negotiate, and oversee budgets with CROs and other vendors for clinical trialsProvide strategic view on operational planning, direction and delivery aligned to corporate goalsProvide strong input to the program teams in all aspects of ideation, planning, and delivery of clinical programsSKILLS & COMPETENCIES:
Impactful leadership skills; conveys a sense of purpose, ownership, and urgency as a collaborative, positive, and decisive leaderDemonstrated ability to build and lead a new functional team at ChromaBroad and deep understanding of the drug development process and associated operational experienceAbility to thrive in a fast-paced, innovative, and dynamic environment while remaining flexible, proactive, and resourcefulHigh degree of organizational awareness and aptitude and an understanding of change management needsPartners, influences, motivates, and inspires with an ability to effectively resolve potential conflicts within a cross-functional matrix team structureStrong interpersonal, communication, and influencing skills for bridging between scientific and business participants, for negotiating timelines, and for effective collaborationExcellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspectivePassionate, adaptable, and keen on working in the fast-paced biotech startup space to drive cutting-edge scienceQUALIFICATIONS:
Bachelors in life or health care sciences; advanced degree preferredPreference 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 leadershipIn-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 inspectionExperience with feasibility analysis for clinical site selection including patient distribution, estimation of recruitment rate, and practical evaluation of site capabilitiesTherapeutic experience in genetic medicines, coupled with experience from early phase through pivotal, global multi-site clinical trials is highly desirableProblem solving in challenging clinical studies required, working knowledge of GCP/ICH, GDPR (General Data Protection Regulation), clinical trial design, regulatory, and clinical development processes
Chroma Medicine is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, Chroma Medicine complies with applicable state and local laws governing nondiscrimination in employment.
COVID-19 Vaccination Policy: All Chroma Medicine team members must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemptions for medical or sincerely held religious beliefs will be considered.
Founded by the world's foremost experts in genomic medicine and backed by industry-leading investors, Chroma is working at the cutting edge of precision genetic medicine, building an entirely new class of therapeutics that can precisely and durably control gene expression without changing or cutting the underlying DNA sequence. Chroma is rapidly advancing novel epigenetic editing therapeutics to patients who are living with serious diseases.
We are hiring at our Boston, Massachusetts site, offering a unique opportunity to be part of our foundational Chroma team.
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 opportunitiesOversee 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 analyticsEnsure effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocolsCollaborate with cross-functional teams including medical, regulatory, legal, and future commercial departmentsKeep 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 colleaguesBuild infrastructure including developing Chroma SOPs where needed to supplement those used from selected CROVendor & 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 strategiesEnsure 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 neededDevelop and maintain strong relationships with CROs, academic partners, and advocacy groups to ensure effective execution of clinical programsCompliance And Risk Management
Ensure all clinical trials comply with local regulatory and ethical requirementsEnsure 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 executionOversee quality assurance and audit processes for clinical trialsBudget & 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 levelsEffectively review, negotiate, and oversee budgets with CROs and other vendors for clinical trialsProvide strategic view on operational planning, direction and delivery aligned to corporate goalsProvide strong input to the program teams in all aspects of ideation, planning, and delivery of clinical programsSKILLS & COMPETENCIES:
Impactful leadership skills; conveys a sense of purpose, ownership, and urgency as a collaborative, positive, and decisive leaderDemonstrated ability to build and lead a new functional team at ChromaBroad and deep understanding of the drug development process and associated operational experienceAbility to thrive in a fast-paced, innovative, and dynamic environment while remaining flexible, proactive, and resourcefulHigh degree of organizational awareness and aptitude and an understanding of change management needsPartners, influences, motivates, and inspires with an ability to effectively resolve potential conflicts within a cross-functional matrix team structureStrong interpersonal, communication, and influencing skills for bridging between scientific and business participants, for negotiating timelines, and for effective collaborationExcellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspectivePassionate, adaptable, and keen on working in the fast-paced biotech startup space to drive cutting-edge scienceQUALIFICATIONS:
Bachelors in life or health care sciences; advanced degree preferredPreference 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 leadershipIn-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 inspectionExperience with feasibility analysis for clinical site selection including patient distribution, estimation of recruitment rate, and practical evaluation of site capabilitiesTherapeutic experience in genetic medicines, coupled with experience from early phase through pivotal, global multi-site clinical trials is highly desirableProblem solving in challenging clinical studies required, working knowledge of GCP/ICH, GDPR (General Data Protection Regulation), clinical trial design, regulatory, and clinical development processes
Chroma Medicine is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, Chroma Medicine complies with applicable state and local laws governing nondiscrimination in employment.
COVID-19 Vaccination Policy: All Chroma Medicine team members must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemptions for medical or sincerely held religious beliefs will be considered.