Associate Director, Clinical Operations, Cambridge

Associate Director, Clinical Operations

New Today

The Role: Moderna is seeking an Associate Director, Clinical Operations to manage studies within the Clinical Operations, Therapeutics and Oncology Therapeutic Area. 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 will work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position will be focused on ongoing studies in metabolic rare diseases, but the role will later support oncology.

Here’s What You’ll Do: Accountable for delivery of assigned clinical study 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 Moderna 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 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

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 Moderna

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 Moderna’s values

Here’s What You’ll Bring to the Table: Minimum of BA/BS with at least 8-10 years of 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). Advanced degree preferred.

Robust experience in oncology required. Experience in immuno-oncology desirable. Experience in ultra rare disease desirable but not required. The ideal candidate has experience with high complexity clinical trials, and late-stage clinical trials, including inspection readiness activities.

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

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Lifestyle Spending Accounts to personalize your well-being journey Family planning and adoption benefits Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities Location-specific perks and extras

Apply

Location:: Cambridge
Job Type:: FullTime

Start a New Search