- Design and build the clinical operations function, including staffing, systems, procedures, and external collaborations
- Establish strong relationships with investigators and clinical site staff; oversee site feasibility assessment, qualification, contracting, and performance management
- Identify, select, and manage contract research organizations and clinical vendors as needed
- Contribute to study and program documents, including clinical protocols, consent forms, case report forms, governance charters, study reports, clinical development plans, and regulatory documents
- Build and track timelines, budgets, milestones, and risk-management plans; partner with the finance team to estimate trial costs and support long-range planning
- Partner with the quality team to ensure compliance and audit-readiness in accordance with all applicable standards and guidelines
- Work collaboratively across functions, in the program team environment, and as a member of the leadership team to achieve corporate goals
- A Bachelor's Degree with at least ten years of Clinical Operations experience in the biopharmaceutical industry
- A thorough understanding of clinical trial processes, including clinical project management, site management, clinical supply, medical writing, data management, and data analysis
- A strong and current knowledge of Good Clinical Practices (GCPs), including ICH, FDA, EMA, and other relevant guidelines
- A prior track record of success in developing and maintaining successful relationships with external partners
- Previous experience with regulatory filings (INDs, CTAs, etc.) with various health authorities (FDA, EMA, etc.)
- Strong leadership capabilities, including excellent communication, presentation, problem-solving, and interpersonal skills; demonstrated ability to succeed in a matrixed environment and lead by influence
- Domain expertise in rare disease drug development and trial recruitment
- Willingness and ability to travel domestically and internationally (up to 20%)
- Prior experience working in advanced therapies (i.e., cell or gene therapy)
- Prior experience with early-stage clinical trials
- Prior experience establishing a Clinical Operations function in a small to mid-size biopharmaceutical company
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Head of Clinical Operations - Boston, United States - Ensoma, Inc.
1 week ago
Description
Position:
Head of
Clinical Operations Location:
Boston, MA
Job Id:
C0001 # of Openings: 1
We are seeking an experienced, collaborative, and motivated individual to serve as Head of Clinical Operations for Ensoma's gene therapy programs.
This role offers an opportunity for a versatile leader with deep clinical operations expertise to become an integral member of the Ensoma team.
You will be responsible for establishing and leading a world-class clinical operations function to conduct industry-leading gene therapy clinical trials across Ensoma's portfolio.
This impactful role is an opportunity to build a function, shape the development of Ensoma's in vivo therapies, and ultimately enable a better future for patients.
Responsibilities:
Qualifications:
Required:
Preferred:
About Ensoma:
Ensoma is a place where you can ask the big questions.
We look at gene therapy today and ask:
What if we could eliminate the patient burden? What if we could treat diseases that affect millions? What if we could treat people anywhere around the world?
Ensoma was founded to answer these questions through our Engenious platform that can transform the hematopoietic (blood & immune) system with a single treatment.
Our Engenious gene therapy platform is the first to precisely engineer any or all hematopoietic and immune cells with a one-time, off-the-shelf in vivo treatment.
Engenious therapies have an unmatched capacity to deliver all modern genetic modification tools and set a new standard for versatile cell programming and control across a range of complex diseases.
We believe the future of medicine lies within us - and this bigger, bolder vision for gene therapy needs incredible people to make it a reality.
For our team, realizing this vision is personal.Founded and guided by leaders drawn from the top of the cell and gene therapy field, we feel an urgency and passion for our work driven by its potential global impact.
A meeting at Ensoma is a space where curiosity, trust, authenticity, problem-solving and professional development are celebrated. A career at Ensoma is an opportunity to be part of the team building the future of medicine.
Ensoma is a 5AM Portfolio company supported by top-tier investors, strategic partners, and a passionate team committed to a bold global vision for genomic medicines.
