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Monte Rosa Therapeutics, Inc
Boston, MA, United States
Overview: Monte Rosa Therapeutics is seeking a highly experienced Clinical Operations professional to lead the successful planning, implementation, and conduct of clinical trials across multiple indications. Reporting to the Head of Clinical Operations, the Director, Clinical Operations will be responsible and accountable for development of operat
Job Source: Monte Rosa Therapeutics, IncCorbus Pharmaceuticals
Norwood, MA, United States
We are seeking a Director, Clinical Operations to provide strategic leadership and operational planning expertise to Corbus Pharmaceuticals clinical development programs. We are looking for an experienced Clinical Program Manager who can lead the creation and high-quality implementation of thoughtful clinical develop plans. This position is both a
Job Source: Corbus PharmaceuticalsActalent
Boston, MA, United States
Job Title: Director Clinical Operations (ONCOLOGY) Job Description As a Director of Clinical Operations (Oncology) - you will be accountable for the operational planning and execution of First-in-Human, clinical pharmacology patient studies, and Phases 1-3 clinical trials (primarily phase III) This role includes responsibility for clinical program
Job Source: ActalentConfidential
Boston, MA, United States
Director, Clinical Operations About the Company Esteemed clinic facility Industry Hospital & Health Care Type Privately Held About the Role The Director, Clinical Operations will be responsible for overseeing operational planning activities, collaborating with cross functional teams, and managing and resolve study conduct issues. Travel Percent 2
Job Source: ConfidentialMonte Rosa Therapeutics, Inc
Boston, MA, United States
Overview: Monte Rosa Therapeutics is seeking a highly experienced Clinical Operations professional to lead the successful planning, implementation, and conduct of clinical trials across multiple indications. Reporting to the Head of Clinical Operations, the Director, Clinical Operations will be responsible and accountable for development of operat
Job Source: Monte Rosa Therapeutics, IncCorbus Pharmaceuticals
Norwood, MA, United States
We are seeking a Director, Clinical Operations to provide strategic leadership and operational planning expertise to Corbus Pharmaceuticals clinical development programs. We are looking for an experienced Clinical Program Manager who can lead the creation and high-quality implementation of thoughtful clinical develop plans. This position is both a
Job Source: Corbus PharmaceuticalsCorbus Pharmaceuticals
Norwood, MA, United States
Company Description Corbus Culture: Our passion. Our purpose. At Corbus, it starts at our core. We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anyti
Job Source: Corbus PharmaceuticalsSchrödinger Inc.
Cambridge, MA, United States
Schrödinger is revolutionizing drug discovery through the use of breakthrough computational methods that are advancing internal programs into the clinic. We’re seeking a Director/Senior Director of Clinical Operations to join the New York-based Early Clinical Development team. This hire will oversee study management activities, budgets, and c
Job Source: Schrödinger Inc.Cambridge, MA, United States
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 is an in-house position at the Vor Bio office in Cambridge, MA
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Email Alert for Director, Clinical Operations jobs in Cambridge, MA, United States
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