We engineer stem cell transplants that shield healthy cells from targeted therapies
Targeted therapies work by attacking cells that express particular proteins on their surface. Unfortunately, both diseased and healthy cells often express the same proteins, resulting in collateral damage to healthy cells.
At Vor Bio, we engineer hematopoietic stem cells (HSCs) to lack a biologically redundant target protein, then transplant these cells into the patient.
These eHSCs give rise to generations of new healthy blood cells that are effectively shielded from targeted therapies so that only the remaining cancer cells are killed. We are also developing our own CAR-T cell therapy using T cells from the same healthy donor who could potentially provide HSCs for our shielded stem cell transplant and thereby, avoid issues of donor-mismatch. We believe our CAR-T cell therapy may enable more potent and durable responses post-transplant.
Vor Bio is aiming to cure blood cancers through our novel platform combining HSC biology, genome engineering, and targeted therapies to unlock treatment options previously unavailable to patients. Come be a part of a passionate team striving to collaboratively develop a groundbreaking approach to cancer treatment, one of medicine’s greatest challenges.
What we value in our fellow Voracians
Passion: Enthusiastically driving our science toward innovative medicines
Fellowship: Fostering genuine bonds of collaboration and mentorship
Humility: Acting selflessly by putting the collective mission first
Who we are looking for:
Vor Bio is seeking a highly motivated Director, Clinical Operations to join our fast-paced, dynamic team at this exciting phase of our Clinical Development Program.
Key areas of responsibility:
- Executes the day-to-day operations of clinical trials from the protocol concept through the clinical study report, per established goals and objectives in compliance with applicable GCP/ICH guidelines, regulations, SOPs and other regulatory requirements as applicable.
- Develops and manages comprehensive trial timelines and metrics.
- Ensure that clinical trials are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
- Develop and manage trial budget(s) and maintain within financial goals.
- Drive selection, management and oversight of external vendors including planning, executing trial-specific meetings, key performance indicators and participates, as applicable, in vendor management governance.
- Lead the identification and management of third-party Clinical Operations vendors, including development of Request for Proposals (RFPs), scope of work (SOW) documents, and vendor specifications.
- Perform and document trial level Sponsor Oversight of outsourced clinical activities.
- Manage invoice and budget tracking for individual trials and provide input into monthly and bi-annual accrual/forecasting activities for trials and programs.
- Review and provide functional input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans, as appropriate.
- Prioritize day-to-day issues and Corporate/Clinical goals, escalating issues to Senior Management as appropriate.
- Provide real time updates to Senior Management and cross-functional teams to ensure seamless communication and collaborative working relationships.
- Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
- Coordinate activities related to audit findings and/or identification of significant site noncompliance.
- Develop relationships with Key Opinion Leaders.
- Coach and provide guidance to Clinical Operations team; may have management responsibilities for Clinical Operations team members.
- Manage direct reports, conduct regular meetings and oversight as well as complete all annual performance review activities, as applicable.
- Train and mentor junior staff on Clinical Operations processes and the related execution of GCP and ICH guidelines such that compliance is the top priority, followed closely by excellent execution of all responsibilities.
- Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance.
- Strive for continuous improvement and more efficient ways of working within the Clinical team.
- May serve as subject matter expert (SME) in one or more areas such as development of SOPs, systems, tools, best in class standards for operational execution etc.
Qualifications:
- Minimum of BA/BS with a minimum of 8 years of clinical trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure).
- Experience with Cell and Gene Therapy is highly desirable and 4+ years Phase 1-3 experience in Oncology is required.
- Robust experience in early and late phase global drug development.
- Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
- Cross-collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
- Advanced working knowledge of current FDA, ICH, GCP regulations and guidelines
- Experience in GCP inspections/audits.
- Outstanding verbal and written communication skills, in addition to excellent organizational skills.
- Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry.
- Resilient, creative, capable problem-solver.
- Excellent organizational skills and ability to work independently.
- Experience in establishing and maintaining relationships with key opinion leaders.
- Ability and willingness to travel up to 20%.
This position requires 3 days onsite at our offices in Cambridge.
By becoming a team member here at Vor, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, parental leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. We are conveniently located in Cambridge with easy access to public transportation and ample parking.
As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Please visit our website at https://www.vorbio.com/ for more information.
