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SalaryWe 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 Senior Clinical Trial Manager to join our dynamic Clinical Operations team. The Senior Clinical Trial Manager (Sr CTM) is a motivated, independent, organized individual who will be responsible for the successful execution of Clinical Trials from protocol conception to the Clinical Study Report. The Sr CTM ensures completion of all study deliverables, oversight of the Clinical Research Organization partner(s)/supporting vendors and proactively identifies and resolves Clinical Trial issues.
Key areas of responsibility:
- Independently lead, manage and coordinate all aspects of the Clinical Trial, including study timelines, budgets and resources to ensure timely execution and successful completion according to Corporate and Departmental goals
- Contribute to and coordinate the development of the Investigator Brochure, Protocol, Informed Consent Form, operational plans, manuals, training materials, patient-facing materials, Case Report Forms etc. and all required regulatory documents
- Participate in vendor selection, generate applicable Request for Proposals, manage and oversee selected Clinical Trial vendors
- Build and maintain collaborative, professional relationships with internal cross-functional teams, CROs/vendors, Investigators and clinical site staff
- Manage and monitor trial progress and performance metrics, providing regular updates to cross-functional team and senior management
- Work with Finance to provide accurate accruals and forecasting; contribute to Long Range Planning budget exercise, as needed
- Participate in periodic study data review and oversee site management to ensure data quality and timely data entry
- Manage (oversee) timely data cuts for external data reviews and presentations, publications etc.
- Lead, manage (oversee) and participate in study-related meetings; Study Team Meetings (internal and external), Investigator/Study Coordinator teleconferences, safety review meetings, DSMB and dose escalation meetings etc
- Proactively identify and mitigate risks and issues that may impact trial budget/timelines, implementing appropriate corrective actions as needed
- Oversee the development and maintenance of the Trial Master File (TMF), ensuring regular TMF audits and a final TMF that is complete and inspection-ready
- Contribute to the development of Clinical SOPs, process improvements and work with Quality to support all audit activities
- Manage the trial in accordance with SOPs, GCP/ICH guidelines and all applicable laws and regulations
- Communicate timely updates to ClinicalTrials.gov postings to Regulatory Affairs
Qualifications:
- Bachelor's degree in health science or a related field
- Minimum 5 years in Clinical Trial management, with 3+ years at a sponsor biotech/pharma
- Experience with Cell and Gene Therapy is highly desirable and 3+ years Phase 1-3 experience in Oncology is required
- Thorough working knowledge of current FDA, ICH, GCP regulations and guidelines
- Strong experience facilitating clinical study team meetings, demonstrated by excellent verbal/written communications skills, presentation skills and effective cross-functional communication
- Excellent organizational skills and ability to prioritize activities, manage timelines, and work effectively in a collaborative, fast-paced, cross-functional environment
- Ability and willingness to travel up to 20% (domestic and international)
This is an on-site position at the Vor Bio office in Cambridge, MA
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.
