Associate Director, Clinical Operations (Oncology)

Our client, a clinical stage biotech in Massachusetts are pioneering a new class of medicines consisting of messenger RNA, or mRNA. The possibilities of using mRNA as a drug are extensive and could meaningfully improve how medicines are discovered, developed and manufactured. Since the company's inception, they have worked to build one of the industry's leading mRNA technology platforms, an infrastructure to expedite drug discovery and early development, a robust clinical-stage pipeline, and a world-class culture and team. The company's pipeline includes assets for mRNA-based therapies that are applicable to a range of disease areas, with multiple pre-clinical trials underway for other assets progressing toward the clinic.

Job Responsibilities:

• 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 client's SOPs
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
• 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 client's 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
• Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs
• 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 client
• 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
• Strive for continuous improvement and more efficient ways of working in clinical development
• Act as a role model for client's values

If you are having difficulty in applying or if you have any questions, please contact Proclinical at clinicaloperationsjobs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.