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location: Cambridge, Massachusetts
job type: Permanent
salary: $180,000 - 190,000 per year
work hours: 9 to 5
The company is seeking a Director of Clinical Operations to manage Rare Disease and Autoimmune programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations within the Rare Disease Therapeutic Area. This position will work collaboratively across the Rare Disease and Autoimmune teams and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.
•Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
•Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
•Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders
•Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and SOPs
•Support the selection, oversight, and management of CROs and other vendors
•Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
•Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
•Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
•Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
•Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
•Perform and document study level Sponsor Oversight of outsourced clinical activities
•Communicate study-status, cost and issues to ensure timely decision-making by senior management
•Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
•Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
•Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
•Develop and foster strong, collaborative relationships with key stakeholders both within and external to the company
•Support program level deliverables/activities at the discretion of the Senior Director, Clinical Operations
•Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise. May include direct management of junior clinical operations staff
•Strive for continuous improvement and more efficient ways of working in clinical development
•Act as a role model for the company's values
•Minimum of BA/BS with at least 8-10 years of trial and clinical program experience. Advanced degree preferred.
•Experience in Rare Disease or Autoimmune indications highly desired
•Solid experience in early and late phase 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.
•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
•Some travel required
skills: SOP, GCP (Good Clinical Practice), Clinical Study Design, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.