Associate Director, Clinical Business Operations

Role Summary:

The Associate Director, Clinical Business Operations provides support for clinical vendor outsourcing and financial oversight, tracking and forecasting for Dyne’s clinical trials. This role is responsible for leading vendor identification and selection efforts in support of Dyne’s Clinical trials ensuring cross functional input and evaluatoin.  Work to optimize and ensure efficent spend within Clinical Operations. The Associate Director, Clinical Business Operations works closely with cross functional teams to ensure a fit-for-purpose outsourcing strategy and budget management is achieved for each trial.  This role will work closely with other internal stakeholders including Finance, Legal and Quality.

 This role is based in Waltham, MA without the possibility of being a remote role.
 
Primary Responsibilities Include:

• Lead and manage the operational aspects of clinical business operations, including overseeing clinical trial budgets, vendor selection and relationship management
• Develop and implement strategic plans to optimize clinical business operations and ensure the efficient and cost-effective execution of clinical trials
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, and finance, to align on trial execution plans and milestones
• Manage relationships with external vendors, CROs, and other partners to ensure high-quality deliverables, adherence to timelines, and budget management
• Assist in the development and management of clinical trial budgets, forecasting and expenses
• Ensure compliance with regulatory requirements, GCP guidelines, and company SOPs in all aspects of clinical business operations
• Provide leadership and mentorship to team members, fostering a culture of collaboration, continuous improvement, and excellence in clinical business operations
• Provide support of the Request for Information (RFI) and/or Proposal (RFP) process for Development programs and/or clinical studies of various phases, complexity, and risk
• Manage contract and financial negotiations with external service providers for Development programs
• Partner with the Legal to ensure that the appropriate templates and legal terms/conditions are applied
• Maintain current knowledge of outsourcing industry trends and provide ongoing support and training to key stakeholders on best outsourcing practices
• Proactively identify and collaborate to address opportunities for process or business improvements including operational efficiencies 
• Embrace and enable diversity of perspectives to enhance the overall effectiveness of the team
• Represent Clinical Operations and support other functions on company-wide process improvements and initiatives 
• Travel up to 25% domestic and/or international

Education and Skills Requirements:

• Bachelor’s degree; advanced degree (e.g., MBA, MPH) preferred
• At least 8 years of experience working within a pharmaceutical/biotech company, CRO, or similar organization
• Demonstrated leadership and project management skills, with a track record of successfully leading cross-functional teams and delivering results on time and within budget
• Excellent communication and interpersonal skills, with the ability to effectively collaborate and establish effective business relationships with internal and external stakeholders at all levels
• Experience in outsourcing management, vendor budget negotiations, budget management, and vendor oversight
• Experience in developing and implementing process improvements and operational efficiencies in clinical business operations
• Experience as a strategic partner providing effective and complex solutions and systems to the organization
• Comprehensive understanding of clinical trial operations regulatory requirements, with an understanding of clinical trial operations
• Strong analytical, negotiating and business communication skills.
• Ability to think strategically and effectively communicate ideas
• Able to interact and influence effectively with multi-functional teams at all levels of the organization
• Self-motivated and able to prioritize and manage a large volume of work in a dynamic, changing, growing start-up culture

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